Insights and resources
Continuing education for the pharma services industry
We have internal subject matter experts and work with technical and scientific experts from across the drug manufacturing and clinical trials industry to bring you whitepapers, articles, webinars, and more to help you through every phase of development, from molecule to medicine.
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Event
Tradeshow
DCAT Week 2023
Join us at DCAT Week in New York City where will be discussing the elements of a trusted partnership and what’s needed to ensure your project goes smoothly, every step of the way.
Event
Tradeshow
Bio-Europe Spring 2023
Join us at Bio-Europe Spring where we will be discussing the elements of a trusted partnership and what’s needed to accelerate your biologic discovery to market.
Fact sheet
Support proof-of-concept studies to move toward cGMP manufacturing
Through Translational Research Services, our interdisciplinary team of scientific experts offer end-to-end support to advanced therapy developers, to generate relevant materials and help ensure a seamless transition from discovery to clinical phase manufacturing.
Whitepaper
Evolving solutions to optimize clinical trial decentralization
This whitepaper highlights Thermo Fisher's solutions to drive high adherence in decentralized trials.
Infographic
Regulatory pathways for CGT and ATMP products
CGT is one of the world's fastest-growing therapeutic areas today. Instead of treating patients for the rest of their lives, these therapies offer them hope of a cure.
In this infographic, we will review three tips for achieving regulatory success.
Infographic
Top 10 traits to look for in a CDMO partner for cell, gene, or advanced therapy medicinal products
This guide can help ease the CDMO selection process by identifying key areas of conflict and uncertainty in the partnership and production process. By proactively asking questions and addressing concerns with CDMO candidates, pharmaceutical companies can minimize conflicts down the line and ensure they have selected a partner that maximizes their chance of success.
Blog post
Top tips for providing the right amount of detail in first-in-human common technical documents
In the early-development stage, little may be known about a drug’s characteristics. What’s more, drug processes and formulations frequently evolve as more information emerges following testing and trials. Learn more.
5 minute read
eBook
Cell and gene therapies in the US vs. the EU: Top five areas of differentiation
In this eBook we share the five key differences in the drug development and review process for companies hoping to gain market access through US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval—as well as tips for navigating these differences.
Infographic
Cell therapy manufacturing workflow
View our new infographic for an overview of a genetically modified cell therapy workflow and the key considerations at each step, ranging from plasmid production through cold chain logistics.
Infographic
A practical guide to writing robust chemistry, manufacturing, and controls dossier modules to support first-in-human trials
Do you need to get your first-in-human (FIH) paperwork in order? This informative checklist can help you draft phase-appropriate chemistry, manufacturing, and controls (CMC) modules for the common technical document (CTD).
Blog post
Enabling a digital culture through integrated business processes
In contrast to a physical work environment, where stability and experience are key, a digital business environment focuses on innovation and connectivity. Learn more.
4 minute read
Blog post
Delivering on the promise of cell and gene therapies: A patient-centric approach
8 minute read
Infographic
Looking both ways for your small biopharma clients
Learn which CDMO partner can lead your biopharma clients down the ideal path and keep client’s projects on time, and on track for regulatory and market success.
Webinar
Enabling a digital culture through integrated business processes
In this webinar, we share our perspective for achieving digital transformation and digital culture enablement, focusing on innovative solutions, opportunities for attaining new levels of operational excellence through proven technologies to drive digital transformation and the Pharma 4.0 journey, and key considerations for transforming the traditional supply chain model into a digitally integrated value chain network
Blog post
Gaining a deeper understanding of your API
As active pharmaceutical ingredients (APIs) become increasingly complex, they pose potential formulation problems that can extend timelines and explode budgets. Read this blog to learn more.
5 minute read
Case study
Midsize pharma company stabilizes API - Accelerates time to clinic from three months to three weeks
A midsize pharma company wanted to progress its therapy from early development to late-phase clinical trial stage, but needed a CDMO partner to provide support in formulation analysis so that it could stabilize its product and successfully reach its clinical studies milestones.
Poster
Accelerating path to clinic through an end-to-end solution focused on supply chain, regulatory, and a robust manufacturing process for viral vectors
Enhancing the path to clinic with an end-to-end solution that addresses supply chain, regulatory, and robust manufacturing processes for viral vectors.
Learn more about a true end-to-end offering for AAV and LV vector manufacturing.
Webinar
Navigating the EU regulatory landscape: Accelerating drug development, treatment innovation and market access
During this three-part webinar series, we cover key areas sponsors must be mindful of during drug development in preparation for filing successful regulators submissions.
Blog post
EU and US regulations: What’s coming for cell and gene therapies?
Cell and gene therapy (CGT) developers today face an added challenge in their quest to bring a product through clinical trials and to the market. Read this blog to learn more.
7 minute read
Webinar
Gateway to China: Developing Biologics for the fastest-growing patient population on Earth
Hear from Yan Fang Ma, general manager of Thermo Fisher’s site in Hangzhou, China, as she describes the opportunities and challenges multinational companies may face bringing biologics and sterile drug products to market in China and the how the right CDMO partner can provide trusted guidance along the way.
Infographic
CDMO checklist to launch your molecule globally
Preparing to take your drug into the global market? You’ll need to make sure your CDMO has what it takes to successfully navigate the global regulatory space with speed, security, and supply safeguards. Use this quick list as a reference when evaluating your options.
Webinar
Future Therapies Track Keynote: Delivering on the promise of cell and gene therapies
Gain insights into the complexities of the CGT ecosystem, and the challenges that must be overcome to successfully move these therapeutics from the laboratory to the patient. Learn about best practices, tools, and integrated solutions for streamlining CGT development and key areas of focus for improving the journey of patients enrolled in CGT clinical trials and beyond.
Video
Autologous and allogenic therapies - today and tomorrow
In this roundtable discussion, clinical and commercial experts address the complex dynamics associated with allogeneic vs. autologous cell therapies and offer insight into the current and future state of the industry. Specific topics include best practices for manufacturing and logistics, regulatory landscape and CMC requirements, and the role of standardization.
Webinar
Addressing cell and gene therapy supply chain challenges through global, integrated solutions
The following webinar features insights from industry experts to help you mitigate supply chain risk and accelerate access to new cell and gene therapies.
Fact sheet
Frederick, MD
Learn more about our facilities in Frederick, Maryland, a center of excellence for ultra-cold and cryogenic storage and distribution of cell and gene therapies.
Brochure
Real Time Track and Trace
Real Time Track and Trace supports enhanced shipment visibility by enabling
tracking of all shipments in one place, viewing cold chain shipments using real-time temperature and location tracking, real-time tracking of delays and excursions, and advanced monitoring for critical cold chain and high value product shipments. Real-Time track and trace keeps the client informed every step of the way
Whitepaper
Comparator sourcing: Leveraging the Bolar exemption to accelerate market access for generic and biosimilar products
Thermo Fisher's Comparator team has the required expertise to leverage the Bolar exemption, providing clients early access to generic / biosimilar drugs.
Strategies to accelerate drug development through harmonization of early and late stage processes
This technical article presents a harmonized and streamlined approach established at Thermo Fisher Scientific for manufacturing AAV and LV vectors for discovery research using technologies and processes mirroring current GMP platforms.
Webinar
Preparing your biologic for commercialization: strategies to reduce risk and optimize outcomes
Leverage the experience of a top CDMO for best practices including how to remain flexible in the face of uncertain market demand, identifying the best practices to a reliable execution, and optimizing the latest digital tools to reduce risk to your timelines
Case study
Thermo Fisher partners with orphan drug developer to resolve dissolution challenges
Learn how Thermo Fisher Scientific’s pharma services team used sophisticated imaging techniques and stability studies to help a pharmaceutical company resolve instability issues, threatening patient safety and successful use of the drug in a Phase III clinical trial.
Webinar
Patient-centric sterile injectables: Improving patient experience through formulation and delivery
Join us for an expert panel of biologics experts as we discuss patient-related characteristics that should inform drug product design decisions, product-related characteristics that can be modified to address the needs of the target patient populations and innovative technologies that can be used to address patient needs
eBook
Decentralized clinical trials in the EU - Strategies and digital solutions for navigating the regulatory landscape
Download this eBook to learn how to navigate the complexity of the regulatory landscape in the EU with the right guidance and resources.
Webinar
Material matters: Material science, process simulation and modeling for oral solid dosage forms
In the development of oral solid dosage forms, predictive modeling and simulation tools of the manufacturing processes can enhance process understanding, save on API supply, improve product quality, and reduce or eliminate many of the bottlenecks associated with empirical methods.
Webinar
Accelerating your biologic’s development: From lab, to clinic, to market
Learn how Thermo Fisher Scientific is supporting new and emerging biotechs to get to clinic and to market, faster. No longer viewed as transactional service providers, CDMOs are an integral part of the pharmaceutical supply chain, and collaboration is foundational to the drug sponsors’ success.
Whitepaper
Targeting cancer with therapeutic antibodies: Solutions for every phase of mAb development
This whitepaper identifies the key challenges faced at each stage of mAb development and provides guidance for streamlining pipeline progress of therapeutic mAb candidates.
Whitepaper
Switching delivery formats: A lifecycle management strategy for sterile injectables
Switching delivery formats can be an effective strategy to enhance they lifecycle of your drug. This whitepaper provides insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.
Webinar
Smart packaging in clinical trials: What clinical supply teams need to know
This webinar is a mix of a short didactic presentation and a panel discussion with clinical supply innovators from across the industry, sharing their experience and lessons learned as they work to normalize the use of adherence measurement tools and smart medicine packages.
Fact sheet
Customs warehouse solution
Learn how our customs warehouse solution can positively impact your overall material import and export costs.
Infographic
The 5 benefits of a customs warehouse solution
See how our customs warehouse solution can simplify your import/export strategy with our interactive infographic.
Infographic
mRNA manufacturing workflow
Like many therapeutic manufacturing workflows, every step in the mRNA process builds upon the prior step. This infographic explores each intertwined step in the mRNA manufacturing process and outlines how Thermo Fisher Scientific’s flexible approach can get your mRNA product to clinic and market faster.
Fact sheet
Commercial autoinjector capabilities
Learn about our commercial autoinjector packaging, labeling and kitting capabilities.
Webinar
Flexible regulatory pathways and key CMC considerations to commercialize cell and gene therapy products
This webinar will provide key advice for determining and navigating the regulatory pathway for any cell and gene therapy.
Webinar
Risk assessment strategies in oral solid dosage development and manufacturing
When you reach each stage in your drug development journey, there are numerous items to look out for as you look to scale up your product.
Fact sheet
Small molecule API solutions
Whether you require standalone API services or fully integrated end to end drug development, we’ll act as extension of your team. Combining the power of deep scientific expertise, industry leading technology, and the backbone of a global network, we’re dedicated to get you closer to your goal.
Whitepaper
Expediting early-phase development of small molecules: An integrated approach
Small molecule drug development has changed substantially in recent years. With the heightened focus on molecularly targeted therapies, small molecule active pharmaceutical ingredients (APIs) and drug products are more complex and potent than ever, requiring increasingly specialized
manufacturing processes and drug delivery solutions. At the same time, the competitive demand for rapid entry into clinical development—combined with accelerated review pathways—translate into compressed manufacturing and delivery timelines.
Infographic
4 time-saving solutions to common early development challenges
In the race to market, you need fast, cost-effective, and scientifically proven solutions to seamlessly guide your molecule through early-phase development. See how we can offer you time saving solutions for your early development.
eBook
Protecting tomorrow: Supporting pharmaceutical and biotech industries to build a sustainable future
Learn how Thermo Fisher is meeting its environmental sustainability goals, and how we work in partnership with the pharma and biotech communities on shared environmental sustainability goals.
Brochure
Large molecule development and manufacturing: Comprehensive offering enabling speed and flexibility
Remove complexity and bring your large molecule to market faster, with less costs and reduced risks utilizing our integrated and customizable offerings.
Whitepaper
Safety first: Controlling occupational exposure in oncology drug development
This whitepaper provides a roadmap for assessing toxicological and potency risks of small molecule oncology compounds, focusing specifically on the following considerations: Criteria for evaluating highly potent small molecules, toxicity banding systems, potency downgrading and safety and handling strategies.
Whitepaper
Advancing drug development using in silico modeling
This report provides a framework for that understanding by outlining some of the processes that stand to gain the most from computational modeling and identifying the in silico capabilities that can be used to accelerate and de-risk each phase of development.
Brochure
Advanced Therapy Services
The advanced therapeutics industry is experiencing accelerated market approval opportunities, record-breaking investments, robust product pipelines, and positive clinical outcomes—all driving the need for speed, regulatory know-how, capacity, and innovation in manufacturing technologies.
Case study
Delivering a large-scale product at a rapid pace
When a pharmaceutical client needed to introduce, manufacture, and validate five stages of challenging chemistry to support a Phase III clinical development program, the Thermo Fisher Scientific pharma services team had to get to work.
eBook
To err is human, to correctly formulate is divine: Risky assumptions for addressing limited bioavailability
Finding a safe and effective compound to bring to market is challenging and costly enough – avoid risking additional expense, be it time or money, by not making these assumptions about the importance of a well planned and executed formulation development strategy.
Fact sheet
Total transportation management
Total Transportation Management manages the complex supply chain processes required to move all types of life science shipments both domestically and internationally.
Fact sheet
Global packaging solutions
Leveraging over 30 years of global clinical packaging and labeling expertise, Thermo Fisher Scientific offers flexible clinical supply services that can help streamline and add speed to your packaging and labeling workflow.
Fact sheet
Clinical trial label services
The challenge of creating labels for investigational drugs increases dramatically as more countries sign on to participate in clinical trials.
Fact sheet
Solutions for high potency
Executing an efficient and optimized high potency strategy early builds a strong foundation when it comes time to scale up manufacturing.
Infographic
5 CDMO attributes for successful late-phase tech transfers
When vetting CDMOs for late-phase tech transfer, ensure success by partnering with a CMDO who has these five key attributes
Infographic
Advances in viral vector manufacturing
No one viral expression system is right for every situation. There will always be tradeoffs and choices to make. This infographic is intended to provide thinking points to help you consider options before deciding which path to take.
Infographic
The unrealized value of a combination drugs strategy
Fixed-dose combination drugs are increasing in popularity due to their clinical benefits over monotherapy alternatives, but there are also several business advantages drug sponsors can derive from utilizing a combination drug strategy. Download the infographic to learn more.
Presentation
Preparing viral vector productions for commercialization
Gene therapy vectors are rapidly approaching the commercial space so commercial readiness is critical for success. Watch our webinar to learn about our capabilities and approaches for preparing viral vectors for commercialization.
Presentation
Quick to Clinic™ viral vector platform
Learn how to leverage scalable, standardized platform process for suspension-based AAV and LV vector manufacture to accelerate time to clinic with this webinar
Blog post
Choosing a CDMO for mRNA success: Five CDMO characteristics needed
The promise of mRNA technologies has been clearly demonstrated during the COVID-19 pandemic, with vaccines reaching the market in record time. The vital role...
7 minute read
Blog post
Trends in mRNA therapeutics: Pandemic learnings for a pathway to success
The rapid advancement of the Pfizer-BioNTech and Moderna messenger RNA–based COVID-19 vaccines from lab to clinic—with development taking less than one year—has validated the...
5 minute read
eBook
Biosimilars: Top 4 differences when managing clinical trial supplies
This eBook outlines the top 4 differences in managing clinical supplies for biosimilar trials. These challenges make biosimilar studies anything but routine for clinical supply teams.
eBook
What are passive shippers and how do they work?
These eBooks outline industry trends and reviews how Fisher Clinical Services solutions are meeting the challenges of the cold chain distribution of clinical
trial supplies all over the world.
Fact sheet
Total transportation management Global supply chain oversight
A fully integrated transportation management service across our clients’ supply chain, from discovery through commercial distribution, with unmatched quality & service.
Infographic
Five tips for managing your clinical ancillary materials
Learn more about the advantages of advance planning when it comes to Clinical Ancillary Supplies.
Article
QP release in the EU in 2022 and beyond: Your questions answered
In a recent webinar titled “QP release in the EU in 2022 and beyond: Your questions answered,” two clinical QP experts from Thermo Fisher
Scientific discussed the expectations and responsibilities of the UK and EU QPs in ensuring supply of clinical and commercial drug products between the UK and the EU. Their observations and responses to key questions are shared in this article.
Fact Sheet
Solutions for formulation challenges
Solutions for formulation challenges Formulation challenges for enhancing the bioavailability of poorly soluble APls can be solved by spray drying. We have extensive capabilities and expertise in process development,...
Fact sheet
Global regulatory services backed by industry experts
Navigating a complex regulatory environment is vital to the success of your product’s lifecycle. Thermo Fisher Scientific provides a range of flexible regulatory solutions that can help easily address your molecule’s unique needs and challenges, while being backed by a global network and seasoned regulatory experts.
Poster
Critical quality attributes for supply of clinical plasmids for cell and gene therapy development
Webinar
Delivered with options & optimism
Behind every successful project is a team of problem solvers, especially when faced with the challenges of a global pandemic.
Webinar
The future of decentralized clinical trials in an evolving EU regulatory landscape
The COVID-19 pandemic has demonstrated the feasibility of adapting clinical trials from site-based endeavors to fully decentralized or hybrid models and has increased global acceptance of decentralized trials as a safe and effective option for accelerating clinical research.
Webinar
Going global: The impact of US foreign trade zones on drug product manufacturing costs and timelines
Learn more about the impact of US foreign trade zones on drug product manufacturing costs and timelines.
Webinar
entering-first-in-human-clinical-trials-a-five-point-strategy-for-building-a-robust-cmc-dossier
This webinar discusses the five strategies to build a robust CMC package, help streamline the path to FIH trials for biologics and establish the quality foundation needed to support all of the development phases toward commercialization
Whitepaper
The changing landscape of oncology drug development: Bringing novel lifesaving therapies to patients
Oncology is the fastest-growing, most active sector of drug development. Matching drug products to clinical and commercial needs requires scientific and technological innovation.
Whitepaper
Technology transfers: Best practices for optimizing success and mitigating risk
Learn more about common pitfalls, best practices, and key elements to make your next tech transfer a success.
Video
Made with N-of-1 & all-for-one
What seemed impossible became achievable when Thermo Fisher Scientific manufactured and released a one-of-a-kind treatment in a record timeline of 30 days.
Video
Solved with intelligence & imagination
When a client faced a complicated packaging challenge, Thermo Fisher Scientific’s Lead Account Manager went to the drawing board, literally.
Video
United with capabilities & compassion
Is it possible to bring your molecule to medicine without a brick and mortar site and no testing labs or distribution capabilities?
Video
United with process & partnership
An experienced CDMO partner with an extensive network makes the difference when it comes to scale-up, tech transfer capabilities, and validation.
Video
Delivered with options & optimism
Behind every successful project is a team of problem solvers, especially when faced with the challenges of a global pandemic.
Webinar
Key considerations when selecting a CDMO partner for cell therapy manufacturing
The cell and gene therapy market is experiencing accelerated market approvals, record breaking investments, robust therapeutic pipelines, and positive clinical outcomes – all driving the need for speed, regulatory know-how, and innovation in manufacturing technologies.
Webinar
Form and fit: Mobilizing integrated resources to transform complex small molecules into high-performing drugs
As clients seek to gain maximum benefit from each clinical stage, the advantages offered by contract partners with integrated services are making these higher returns tangible.
Webinar
An optimized approach to drug development
Take months off the development timelines of your large and small molecule discoveries.
Webinar
Manufacturing strategies for plasmid DNA in advanced therapy applications
As the cell and gene therapy market continues to experience rapid investment and increased IND submissions, new questions arise regarding appropriate application of regulatory guidelines and manufacturing strategies for the critical raw materials used in the development of these ground-breaking treatments.
Webinar
Breakthrough Therapy Designation: Evaluation of trends and impact on CMC Strategies
Breakthrough Therapy Designation (BTD) was introduced by the US FDA to help shorten the development and review time of novel drugs intended to treat serious or life-threatening diseases.
Webinar
Stabilizing your supply chain in times of global volatility
A stable supply chain is critical to making sure your drug product is manufactured and delivered to patients on time.
Poster
Hot Melt Extrusion Process Optimization and Formulation Development of Amorphous Solid Dispersions for a Poorly Soluble Calcium Channel Blocker
Poster
Evaluate Impact of Spray Drying Process Parameters and Equipment Type on the Granule Characteristic of the Immediate Release Tablets of a BCS Class-IV Drug
Poster
Developing a High API Load Immediate Release Tablet by Switching from a Wet to a Dry Granulation and DoE Formulation
Poster
Poster
Evaluation of a Quality by Design (QbD) Approach for Process Development and Scale-Up of a Novel ALS Drug Product
Poster
Determine the Dosing Disk and Encapsulation Speed for Encapsulation of a Drug Product Using Automated Encapsulator
Poster
Enhanced Solubilization of an Analgesic/Antipyretic Drug With The Use of Polymeric Excipients
Poster
Poster
Poster
Comparative PK Performance of Solution and Suspension Based Formulations For a BCS Class II Molecule in a Soft Gelatin Based Dosage Form
Poster
Development of a High Shear Wet Granulation Process Through the Use of Design of Experiments
Poster
Fact sheet
Bend, Oregon
Our Bend facility is our site network’s Center of Excellence for Solubility.
Fact sheet
Bishops Stortford, United Kingdom
Our Bishops Stortford facility in the United Kingdom provides GMP biologics storage and cell therapy clinical trial support.
Article
Q&A: BIO EXPERTS: Post-discovery priorities: Streamlining your molecule’s route to IND
Time to market is paramount for many companies starting to consider post-discovery development and strategic plans for bringing a molecule into clinical trials and beyond. Strategies and tactics for shortening timelines often involve trade-offs related to risk and future needs, making early-phase decision-making a balancing act for even the most promising molecules. Read what our experts how to say about the critical considerations that impact timing and commercialization.
Understanding the roles of solid-state characterization and crystallization within the product lifecycle
Understanding the roles of solid-state characterization and crystallization within the product lifecycle The physical properties of a solid active pharmaceutical ingredient (API) dictate the crystallization process used for isolation,...
Insider insights – Q&A with Tom Holmes of Amylyx Pharmaceuticals
When two young innovators, Justin Klee and Joshua Cohen, Co-Founders and Co-CEOs of Amylyx Pharmaceuticals, discovered a potentially life-changing molecule in their dorm room at Brown University, they embarked on a journey to clinical trials to help treat people living with ALS. Amylyx’ Global Head of Supply Chain, Tom Holmes, shares more about their experience teaming up with Thermo Fisher Scientific to manufacture their product.
Brochure
Solid and Sterile Dose Form Overview
Oral Solids. Access a remarkable range of conventional and specialized oral solid dosage form capabilities and scale. Further expand your options with innovative combinations of these forms and a...
Smart Packaging – Gain Confidence in Clinical Trial Outcomes
Smart Packaging – Gain Confidence in Clinical Trial Outcomes Evaluating and onboarding new vendors to implement a new technology can be daunting. The team at Patheon pharma services has...
Top strategic tips for filing a successful IND with speed and efficiency
Top strategic tips for filing a successful IND with speed and efficiency Planning for your IND submission takes careful consideration and the right people on your team.
Four special fill/finish considerations for vaccine production
Four special fill/finish considerations for vaccine production
Top strategic tips for filing a successful IND/IMPD with speed and efficiency
Planning for your IND/IMPD submission takes careful consideration and the right people on your team. With proper planning, you can get your filing right the first time and avoid rework later as you expand scope and markets. View the infographic for 8 strategic tips that can take you from confused to confident in your regulatory journey.
Getting your biologic to IMPD faster in EMEA
This infographic provides insight into how to balance speed, risk and future needs so as to accelerate your biologic discovery to market in Europe.
Real-time Track and Trace platform for clinical trial shipments
Real-time Track and Trace platform for clinical trial shipments Real-time Track and Trace platform for clinical trial shipments Thermo Fisher Scientific’s Track and Trace solutions provide internal and external...
Whitepaper
Phase Appropriate Formulation and Process Design
Pharmaceutical companies walk a tightrope in early drug development. They have to balance speed, quality, scientific risk, and API cost. Compromising on any one of these four crucial elements...
mRNA vaccine development: Key insights for planning, workflow, and supply chain success
In this report, we will review key insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of mRNA vaccines and...
European regulatory landscape: Demystifying new Qualified Person (QP) requirements for supplying medicine in the EU and UK
To ensure full compliance and timely and efficient batch release processes, drug sponsors pursuing clinical trials and commercialization in the EU and UK require a deep understanding of European...
Article
Prepping for commercialization through supply chain logistics
Read the following article for insights on common supply chain challenges and considerations when preparing for commercialization of cell and gene therapy products.
Fact Sheet
cGMP plasmid DNA manufacturing capabilities
cGMP plasmid DNA manufacturing capabilities As the global plasmid market continues to grow rapidly, current and projected demand for high quality plasmid continues to be challenged by the availability...
Fact Sheet
cGMP Cell therapy manufacturing Capabilities
cGMP Cell therapy manufacturing Capabilities The cell and gene therapy market is experiencing accelerated market approval opportunities, record breaking investments, robust therapeutic pipelines, and positive clinical outcomes – all...
Fact Sheet
Advanced therapy supply chain solutions
From customized packaging and labeling to secure cold chain storage of patient samples, drugs and cell lines, Thermo Fisher Scientific delivers unparalleled supply chain management solutions to serve the...
Infographic
Best practices in viral vector analytical characterization
Best practices in viral vector analytical characterization Characterizing viral vector products and associated impurities is critical to ensuring the safety and efficacy of viral vector therapies. View the following...
Whitepaper
Leveraging innovations in plasmid manufacturing to bring advanced therapies to market
Download this whitepaper for insights on market trends influencing the supply of pDNA for advanced therapies, as well as manufacturing strategies to help accelerate timelines, mitigate risk and...
Article
EU Clinical Trial Regulation 2022 –Impact on Regulatory, Labeling & QP
A panel of Thermo Fisher Scientific experts discuss the implications of the new EU Clinical Trial Regulation for pharmaceutical companies and their research and commercial partners
Case Study
Consolidating the distribution approach for global clinical trials
Consolidating the distribution approach for global clinical trials A global top-ten pharmaceutical manufacturer needed help improving their distribution strategy. Read this case study to learn how Thermo Fisher Scientific,...
Blog post
Moving from vials to prefilled syringes for vaccines: Three key success factors
As pharmaceutical companies become more patient-centric and self-administration of injectable drugs continues to increase, the market for drug products in prefilled syringes is forecast to grow, reaching $9.53 billion by 2026.
4 minute read
Infographic
Decision point: Build vs. buy continuous manufacturing
Continuous manufacturing is quickly gaining momentum and adoption within the industry due to its cost-saving benefits. Read more to evaluate which is the right option for your company.
Infographic
Five Ways to Get to IND/IMPD Faster
The road to IND/IMPD isn’t always easy. Balancing speed, risk, and future needs is a challenge. So how do you get to IND/IMPD faster without sacrificing quality and future commercialization goals? Check out this infographic to see suggestions from our experts about accelerating and optimizing your early development process.
Infographic
A Tale of Two CDMOs: Which Choice Will Your Biopharma Make?
Today’s growing biologics challenges make the choice of a CDMO critical. You need a trusted and experienced partner from DNA sequence to commercial launch and at each checkpoint along the way.
Infographic
CDMO Timebombs: Five Ways the Wrong Partner Can Lead to Trouble Down the Road
In the evolving biopharmaceutical industry, there is one thing you can count on: Unpredictability. It is in the nature of large molecules generating complex biological activity as scientists seek the right combination of purity, potency, safety and stability – from cell lines to commercialization.
Infographic
Find Your Dream Dose Form: Match-Making Your Brand to the Right Innovation
Managing the lifecycle of your over-the-counter (OTC) drug brand means expanding shelf space, generating premium pricing, and continually innovating in order to win market share from competitors. Download this infographic to meet five high-quality, increasingly popular technologies that may hold the key to your brand’s healthy growth and greater differentiation.
Infographic
10 Reasons Formulation Complexity is on the Rise in Steriles
Within early development, there are a variety of different challenges that hinder a molecule’s ability to progress to the next phase such as complex formulation. The complexity of sterile drug development has been on the rise, which is driven by a variety of different factors.
Infographic
Small Pharma, Big Opportunity: Should CDMO Partner Size Influence Selection for your Large Molecule Project?
Overview: With resource constraints and process development challenges within early development, new & emerging companies are often left with the difficult decision on whether to select a small or large CDMO for their steriles drug product. This critical decision not only has implications within early development , but also with scale-up and commercialization.
Infographic
Critical quality attributes of plasmid DNA for advanced therapies
Plasmid DNA forms the genetic foundation for many therapeutic strategies, yet shifting market dynamics such as capacity constraints, potential operational disruptions due to company consolidations and acquisitions, and evolving regulatory guidelines can create complexities in developing a manufacturing strategy for this critical material. Download the following infographic for helpful insights on critical quality attributes impacting plasmid DNA.
Infographic
Delivered with speed and service
An overview of our EU central pharmacy solution to support decentralized clinical trials in the EU – a step-by-step approach.
Location
Hangzhou, China
Kanghong Road, Hangzhou
Biotech Valley, Xiaoshan district
Hangzhou city, Zhejiang, China
Our Stories
Meet Justin & Joshua
How two college kids took a dorm-room idea all the way to clinical trials.
Our Stories
Meet Chris
How a small non-profit teamed up with a global manufacturer to bring their ALS drug to clinical trials.
Our Stories
Meet Katie
How viral vector technology is rapidly scaling up to enable one miracle after another.
Our Stories
Meet Linda
How one brave patient went from the heart transplant list to climbing the mountain trails.
Our Stories
Meet Pete & Lisa
How a combination of medicines helped one man take back his life, and inspire us all.
Our Stories
Meet Holli
How spring break had to wait a little longer, so a baby could have a better shot.
Our Stories
Meet Jigal & Jessical
How digging deep into Canadian regulations got a client's medication onto shelves in Brazil.
Our Stories
Meet The Tubesings
How a family's perseverance helped them reach a seeemingly unattainable goal.
Our Stories
Meet Nicole & Gavin
How one incredibly brave kid inspired a one of a kind clinical trial.
Our Stories
Meet Marcus
How one split-second decision made a difference for thousands of patients.
Our Stories
Meet Angie
How a combination of teamwork, heart, and science ensured thousands of patients around the globe didn't go without medicine.
Our Stories
Meet Jeff
How a small startup was able to scale up, without losing their precious material.
Our Stories
Our Stories
Meet Emily & Jessica
How in a culture of knowledge sharing, a mentor paved the way to success for their mentee.
Webinar
Advanced therapies and large molecule investments
Global expansions in development and manufacturing of biologics, cell & gene therapies, and drug products and expansion of clinical supply-chain capabilities
Webinar
Amorphous Dispersion Drug Formulations: A Modern Simulation-Based Approach
Experts explain how to use a structured combination of materials science and molecular modeling to develop a rational formulation design for amorphous dispersions with reduced empiricism.
Webinar
Anticipating the Formulation Challenges of Complex Molecules
Formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.
Webinar
Building a robust FIH biologics regulatory CMC package
When you enter the clinical trial stage of your molecule’s development, you must prepare a dossier to support conducting the clinical research.
Webinar
Bulletproof Your Supply Chain: Hope for the Best, Prepare for the Worst
Incorporating a well-thought out contingency plan is critical when developing a clinical and commercial supply chain.
Webinar
Case Study: Curbing the Opioid Epidemic with Pacira Pharmaceuticals
View this webcast to hear how Pacira is utilizing Patheon’s condominium manufacturing model to manufacture EXPAREL.
Webinar
Challenge Accepted: Biopharma Puts COVID-19 in Its Pipeline
Numerous players are pitching into the fight against COVID-19, with pharma and biotech companies, governments, academic institutions, nonprofits and others working on tests to diagnose the disease and developing vaccines to prevent it.
Webinar
Challenges and practical solutions for changing over to pre-filled syringes for parenteral drug
It’s not uncommon for companies who launch commercial drug products in the pre-filled syringe format to do so after initially using other product formats such as vials for the development and clinical trial phases.
Webinar
Challenges in the Development of Complex Small-Molecule Drugs
Learn the many pieces to the development puzzle of complex small-molecule drugs when taking a new chemical entity to market and potential challenges facing a complex molecule while moving through development.
Webinar
China: Opportunities & high growth potential for global and domestic pharma
How pharma companies in China can leverage the experience of the global market
Webinar
Choosing the Best Biomanufacturing Strategy: The Value of a Multi-Pronged Approach
Hear industry experts discuss the benefits of having a flexible, multi-pronged approach to biomanufacturing, along with the pros and cons of outsourcing versus staying in-house for biologics drug-substance manufacturing.
Webinar
Choosing the Right CDMO for Late Phase Clinical Trials
Gain insight into the importance of looking for a CDMO partner with extensive experience in the parenteral arena, as products move through clinical phases and toward commercialization.
Webinar
Comparator Strategic Sourcing Solutions
Join the webinar by Natalia Kozik, Program Manager, Comparator Sourcing to learn about Thermo Fisher Scientific’s comparator sourcing capabilities.
Webinar
Conventional vs. Unconventional Spray Drying Strategies: Development to Commercialization
Industry experts from across our global network discuss conventional and unconventional spray drying strategies to address bioavailability or crystallization challenges.
Webinar
COVID-19 Threatens Pharma’s Global Supply Chain. What Next?
Hear experts discuss how to navigate the current global supply chain challenges and what improvements Big Pharma and biotech firms should make from the COVID-19 outbreak moving forward.
Webinar
Developments and Opportunities in Continuous Manufacturing
Ensures greater flexibility of supply
Webinar
Does Your Clinical Trial Design Satisfy the Needs of your Patients?
While patient-centric design increases convenience and provides an uninterrupted flow of medication for the patient, it can also positively impact trial enrollment and retention for Sponsors.
Webinar
Driving Supply Chain Productivity in Cell Therapy Clinical Trials
Learn about identifying risks in your cell or gene therapy clinical supply chain, mitigate risk and set yourself up for commercial success.
Webinar
Ensure the Scalability of Your Molecule with a Science-Driven, Phase-Appropriate Approach
Hear experts evaluate how development teams can balance molecule needs and mitigate risks by applying phase-appropriate, science-driven formulation and design principles.
Webinar
Essential up-front planning for your clinical trial
Early, upfront planning of your clinical supply chain is critical to ensuring programs effectively balance risk and cost.
Webinar
EU Clinical Trial Regulation 2022 – Impact on regulatory, labeling and QP
Navigating the new regulatory changes is vital for successfully progressing complex clinical trials in the EU market and ensuring the timely supply of your Investigational Medicinal Products (IMPs).
Webinar
Flexible Solutions to Speed Your Molecules to Phase I Clinical Trials
Watch this webcast to learn how to address early clinical development challenges, and how Thermo Fisher Scientific’s Quick to Clinic™ for Oral Solid Dose can help.
Webinar
From Patient Adherence to Manufacturing Ease—Why Softgels Make Sense for Rx
When it comes to prescription drugs, softgels are not often top of mind for formulators.
Webinar
Getting from R&D to IND – Pitfalls to avoid and how to succeed
How integrated solutions can optimize and speed up the entire DNA to IND workflow and why they’re an effective way to go from an R&D lab to the clinic.
Webinar
Getting your global, small molecule CMC regulatory strategy right from the start
Drug development is dynamic and engages CMC regulatory input at each step.
Webinar
Highly potent strategies from early development to commercialization
Pharmaceutical R&D is focusing on developing more specialized drugs, resulting in increasingly more potent APIs.
Webinar
How an integrated global network of technical, quality and customer engagement teams can support the drug development journey for biologics
Expertise to drive the decisions in the right way to avoid rework and wasting of time.
Webinar
Importance of a one-stop-shop for clinical packaging and labeling in a GMP environment
Join the webinar by Robert Scarth, General Manager, Global Label Services, to learn importance of a one-stop-shop for clinical packaging and labeling in a GMP environment.
Webinar
Innovative Solutions to Bring Medicines to Patients Faster
Watch this webinar to learn about Thermo Fisher Scientific’s $800 million investments in biologics, cell and gene therapy, and drug product capabilities to help biopharma and pharma companies of all sizes accelerate commercialization and bring medicines to patients faster.
Webinar
ISPE Virtual Inspections: Navigating the New Paradigm
Understanding the regulatory landscape for biologics is essential.
Webinar
Leveraging Infrastructure Investments and Innovation to Accelerate Biologics Development
This webinar showcases how Thermo Fisher Scientific is leveraging infrastructure investments and innovation to deliver platform and bespoke solutions meant to accelerate biologics development.
Webinar
Post Pandemic Planning: What Will Change in Early-Phase Drug Development?
Watch as our early development experts discuss the impact of COVID-19 on sponsor/CDMO relationships moving forward, how Thermo Fisher Scientific has maintained normal CDMO operations and plans to shift to meet new needs and more.
Webinar
Post-Pandemic Planning: What Will Change in the Clinical Supply Chain?
Watch as our clinical supply experts discuss the changes the clinical supply chain will face as a lasting result of COVID-19, how innovations from clinical service organizations such as Thermo Fisher will help move trials forward, and more.
Webinar
Practical Implementation of Innovative and Scalable Technologies to Accelerate Biologics Development and Commercialization: A CDMO Perspective
Watch this webinar to learn how new and innovative technologies and best in class manufacturing capabilities can help alleviate challenges in Biologics development.
Webinar
Process Characterization: Ready For The FDA?
Impact of process characterization and process validation/PPQ campaigns.
Webinar
Process Characterization: Ready for the FDA/EU ICH guidelines
There is a common view among biopharmaceutical regulatory agencies that process validation is requirement for all commercial products.
Webinar
QP Release for drug products in Europe
Understanding regulatory legislation is vital for successfully navigating the complex global clinical trials market and ensuring the timely supply of your Investigational Medicinal Products (IMPs).
Webinar
Regulatory uncertainties: Continuous manufacturing
One of the biggest barriers manufacturers point to when it comes to the lack of widespread adoption of continuous manufacturing is uncertainty.
Webinar
So Many Choices: What’s the Right Biomanufacturing Strategy for Me?
Watch excerpts from this Patheon-sponsored super session at BIO International, as Steve Lam presents, “So Many Choices: What’s the Right Biomanufacturing Strategy for Me?”
Webinar
Taking a More Informed Approach to Solubility Enhancement
Patheon Solubility Enhancement Services approaches BCS II drug substance solubility issues a fundamentally different way.
Webinar
Taking An Informed Approach To Technology Selection To Address Solubility Challenges In Early Development
As the need for more targeted drug therapies has increased and drug development has become more complex, the industry has seen a corresponding rise in the number of molecules with low solubility challenges.
Webinar
Technology transfers: Best practices for optimizing success and mitigating risk
When working with the right partner and network, transferring production between sites allows companies to reap a variety of strategic advantages.
Webinar
Top 5 Considerations When Looking to Outsource to a Biomanufacturing Partner
Join Paul Jorjorian for a 20 minute “Ask the Expert” webcast with BioProcess International.
Webinar
Transportation Solutions for Cell and Gene Therapy
From the basics such as service level expectations for couriers versus integrators, to how to evaluate domestic and international lanes, and finally—how to balance risk and cost, this webinar will help you understand how to start tackling your clinical supply chain.
Webinar
Vaccine Development: Strategic Approach & Response During Pandemics
Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have sparked ongoing conversations about strategic approaches and responses to pandemics and epidemics.
Webinar
Your Clinical Results Look Promising, but are You Ready for Launch? How to Build a Robust Packaging Strategy for Rapid Commercialization
Now that you are starting to see promising clinical results, the focus quickly shifts to commercialization and the many challenges that come from planning a pharmaceutical packaging strategy.
Webinar
QP release in the EU in 2022 and beyond: Your questions answered
In Europe, and in the UK, the Qualified Person (QP) plays a crucial role in bringing safe and timely products to the market and/or supplying them to the clinic.
Webinar
Establishing a correctly characterized molecule in early drug development
The physical properties of a solid active pharmaceutical ingredient (API) largely determine the crystallization process used for isolation, purification and form control, and also guide the development of an effective formulation.
Webinar
Regulatory and cost implications for switching injectable delivery formats
Since there are various options for injectable formats, it’s not an uncommon practice to launch a large molecule in one format and then later decide to switch the delivery format.
Webinar
Addressing scalability challenges in the development and manufacture of gene therapies
Viral Vectors have been approved for use in gene therapies, gene modified cell therapies, and vaccines to address rare disease, cancer and public health issues
Webinar
Addressing technical challenges in development drug products: A CDMO perspective
Throughout the development of small and large molecule drug products, there are various demands and technical challenges that can cause lengthy and costly delays.
Webinar
Building viral vector capacity and capabilities to realise the promise of gene therapies
Challenges and opportunities of bringing viral vector products to market.
Webinar
Cell and gene therapy manufacturing in a post-covid world
In this webinar, our speakers will share their expertise in cell and gene therapy manufacturing, and discuss the future of the industry, and how developers can adapt to this new paradigm.
Webinar
Common Softgel Myths Debunked
Watch as Kaspar van den Dries, Senior Director of Science and Innovation at Thermo Fisher Scientific, deconstructs common myths surrounding softgels for prescription formulation.
Webinar
Continuous manufacturing: Drug development workflow and benefits
Overview the economic and quality benefits of oral solid dose continuous manufacturing for commercial drug products and understand how leveraging continuous manufacturing in development can allow greater assurance of quality as well as scale up efficiencies.
Webinar
Critical Quality Attributes for supply of clinical plasmids for cell and gene therapy development
Plasmid DNA is a critical raw material for establishing the genetic basis for cell & gene therapy medicines.
Webinar
Drug repurposing trends—A CDMO perspective
Overview the trends and CDMO perspectives on the low-risk, cost effective drug repurposing strategy to bring off-patent generics, clinical, shelved drugs or combination drugs to treat different indications and faster to market.
Webinar
Early Stage Development for Solid Dose Products
Review challenges experienced in early stage development of solid oral dosage forms and the implications of these challenges on a development program.
Webinar
Executive Research: Impact of Incorrect Forecasts on New Product Launches
Hear the results of the ORC International study, including forecasting processes, key issues that arise from inaccurate forecasts, and how forecasting needs will change over the next few years due to evolving organizational needs.
Webinar
FDA Accelerated Approval Pathways for Cell and Gene Therapy Products
Understanding the regulatory landscape is essential. It is changing as fast as the industry is changing.
Webinar
Fixed dose combination drug development: Designing a lifecycle strategy with agility & speed
The development of fixed dose combinations and drug repurposing projects are commonly adopted lifecycle management strategies for the enhancement of individual drugs.
Webinar
How Adaptable Manufacturing Models are Paving a Steady Path into an Unpredictable Future
In a short 20 minutes, you can learn about manufacturing trends, adaptable manufacturing models, and take a tour of Pacira’s condominium manufacturing facility at Patheon’s Swindon location.
Webinar
How Well Should You Understand Your Crystallization Process (and Solid-State Properties)?
Crystallization is the most common unit operation for isolation and purification of solid intermediates and active pharmaceutical ingredients (APIs).
Webinar
Identifying and Solving Scale-up Challenges in the Synthesis and Formulation of Small-Molecule APIs
Join pharma services expert, Dr. Peter Poechlauer, as he examines the process of identifying and solving scale-up challenges in the synthesis and formulation of small-molecule APIs.
Webinar
Manufacturing Innovation: The Case for Continuous Manufacturing
During this on-demand webinar, hear from industry expert Doug Hausner compare and contrast continuous manufacturing and traditional batch manufacturing.
Webinar
mRNA vaccines, trends, technologies and supply chain
Challenges and considerations for achieving a robust global vaccine supply chain.
Webinar
Navigating Decision Points to Fast-Track Commercialisation
Understanding the risks, requirements and challenges of bringing clinical products through validation and to the market are vital for the success of your large molecule project.
Webinar
Orphan Drugs: Balancing Financial Incentives & Complex Challenges
Orphan Drugs are notorious for their high costs and risk factors, which is attributed to smaller patient pools and higher development and launch costs.
Webinar
Parenteral drug market: Meeting escalating challenges
Listen to this on-demand webinar to hear from industry experts, Christy Eatmon and Peter Shapiro.
Webinar
Phase-Appropriate Formulation Development & Manufacturing for Parenteral Dosage Forms
Watch this webinar to discover the criteria that pharmaceutical development teams should consider when ensuring their parenteral dosage form is prepared to scale to late stage and commercial.
Webinar
Preparing for an evolving regulatory landscape to successfully commercialize cell and gene therapies
Cell and gene therapies are progressing through clinical trials and driving towards commercialization at a rapid pace.
Webinar
Shortening the timeline to first in human (FIH) clinical dosage form for oral / injectable delivery
In recent years, with more clinical candidates being explored for niche indications, orphan drugs, and for indications with a rapid clinical end point, the pathway to the later clinical phase is short and there is not enough time to perform bridging studies.
Webinar
Simplify Your Supply Chain in the Race to Phase 1
In this webinar, experts Kevin Kane, PhD and Iain McGroarty, PhD discuss how a simplified supply chain may help increase efficiency and reduce risk as your move to your Phase I milestone.
Webinar
The Advantages of Employing a Lipid-Based Formulation Process in Early Development
In this webinar, experts will explain the benefits of considering lipid formulation early in the development process and how a structured screening and development approach can assist in overcoming potential barriers associated with lipid formulations.
Webinar
Trends and Challenges in Outsourced Oral Solid Dosage Forms
As drug companies have fewer and fewer new compounds entering their R&D pipelines, outsourcing of development and manufacturing activities for oral solid dosage forms and sterile forms is on the rise.
Webinar
What to Look For in a Solubility Enhancement Vendor
Patheon’s Kaspar Van den Dries sits down with Pharmaceutical Technology Magazine to discuss which crucial characteristics you should look for when researching and selecting a solubility enhancement vendor.
Webinar
Why are Lipid Formulations Commonly Used to Enhance Bioavailability?
Join Thermo Fisher Scientific’s Kaspar van den Dries and Helena Teles as they discuss potential mechanisms of increased absorption with lipid formulations, the appropriate screening tools used during the development approach of these formulations, and the subsequent steps to scale up and industrialize them.
Webinar
Why Did Thermo Fisher Scientific Acquire Patheon?
In August 2017, Thermo Fisher Scientific completed the acquisition of Patheon, creating the world’s most comprehensive and sophisticated end-to-end CDMO partner.
Webinar
Smart packaging: The power of adherence data
The value of individual data points that are passively captured at each patient medication dosing event are often overshadowed.
Webinar
A toxicologist’s viewpoint on developing oncology drug products
With oncology growth rates on the rise, pharma companies are pressured to develop and manufacture life-saving therapies with speed and agility.
eBook
Using an Approved Phrase Library
Find out how to avoid delays in translating and approving clinical labels that can prevent clinical trials from starting on time and threaten to derail development timelines.
eBook
Total Transportation Management
The transportation of life science shipments has become increasingly more complex. Learn how to overcome challenges and avoid the high cost of failure.
eBook
The Challenge of Keeping Cool: End-to-End Temperature Management for the Clinical Supply Chain
Learn about managing the storage and transportation environment, what the regulatory definitions are, and planning for end-to-end temperature management.
eBook
Smooth Transition: What Specialty Drug Manufacturers Should Know About Bridging the Gap from Clinical-to-Commercial Packaging
As a steady stream of specialty drugs enter the marketplace, pharmaceutical companies are seeking new supply chain solutions to ensure that an uninterrupted supply of these breakthrough treatments reach patients. One solution for the challenges of packaging specialty products is low- or small volume commercial packaging.
eBook
Reasons for Building an Approved Phrase Library
Learn how an approved phrase library can reduce label timelines, improve quality, and assure regulatory compliance.
eBook
Managing Temperature Excursions: Key Pointers That Must Be Addressed
Discover what to do when a temperature excursion occurs and get summary recommendations on how to handle cold chain or temperature sensitive IMP across the supply chain.
eBook
Importer of Record Frequently Asked Questions
Get answers to frequently asked Importer of Record questions, a checklist of roles and responsibilities and a glossary of terms.
eBook
Evaluating and Qualifying Temperature Managed Shippers
Discover the top 5 questions to ask when evaluating shipper options and the many benefits of return and re-use programs. Plus, get the results of a case study and pilot program.
eBook
Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics
Download the eBook to learn about the different types of considerations when shipping biologics.
eBook
Cold Chain Industry Trends
Take a look at the importance of a robust supply chain and get planning recommendations for pharma companies scaling up to global vaccine trials.
eBook
Clinical Trial Packaging: Innovative, Flexible and Time-Sensitive Solutions
Clinical trial packaging solutions can be as diverse as the medications they protect. Learn how our clinical study sponsors were able to implement a packaging design that scaled through all phases of the trial while reducing time and waste.
eBook
Clinical Trial Packaging Solutions: Balancing Cost, Time and Quality
Explore critical factors in the packaging design process that can deliver the best possible outcome for your clinical study and, ultimately, the patient.
eBook
Clinical Trial Packaging: Smart Choices Can Trim Timelines
Get important insights to help guide the development of your packaging strategy to streamline study timelines and increase the likelihood of success.
eBook
Beyond Procurement: Taking a Strategic Approach to Comparator Drug Sourcing
Sourcing a comparator drug with the highest quality and with a short lead-time can be challenging. Find out how a strategic approach can help.
eBook
Ancillary Management: Keep Your Clinical Trial on Track
Learn the industry trends that are driving increased focus on a successful ancillary strategy and important considerations to develop a comprehensive strategy that minimizes risk.
eBook
Top 5 Questions Asked About Pre-Filled Syringes
Asking key questions of your prospective supplier will help you make a better selection and design a better solution. Find out what they are and why they're important.
eBook
Future Forward: How your outsourcing strategy shapes your development strategy
Once you decide if you are going to outsource drug product manufacturing, it's important to start building a robust strategy that helps you move through each phase with agility and speed. Part of that strategy entails a key decision point. Should you outsource your development program to: 1. Single vendor 2. Several vendors
eBook
The 5 pitfalls of API development
No matter where you are in the API development life cycle, early planning makes a big difference. Download this slide module to learn about common pitfalls in each stage of development and how the right outsourcing partner can help you avoid them.
eBook
Growing Your Biopharma: Ten Questions You’re Likely to Face From Investors—And How to Respond to Them
There are many important considerations to address in building your new drug program. Without a doubt, one of the most critical is funding to get you to your next milestone. As you grapple with funding issues, it can be useful to consider the point of view of a potential investor. Investors are betting on you to manage development effectively and to move quickly.
eBook
There May Be Dragons: Mapping 7 New & Emerging Pharma Development Risks
You have to think about things like technology transfers, shipping and logistics, as well as the increasingly complicated regulatory expectations across countries. Large pharma companies often have the staff and experience to manage and move drug products and ancillaries within and across borders, but new and emerging companies tend to run lean and be scientifically focused. As a result, you may not have the resources or expertise to coordinate development programs across multiple sites, geographies or vendors. This eBook is designed to help you map seven key risk areas in drug development and clinical services—and build a plan to overcome them.
eBook
No Place like Home: How to Make Decentralized Clinical Trials a Win for Patients, Sponsors & Investigators
Download this eBook to learn about the integral role Direct-to-Patient Services play in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.
eBook
Validation or Qualification – What’s the difference?
For those studying, manufacturing, or experimenting with delicate pharmaceuticals and biological samples, the importance of sample storage and accurate temperature monitoring is well known. From a qualification and validation perspective, the equipment and processes used for shipping, storing (whether refrigerated storage or ultra-cold storage), and other services must comply with the products’ requirements throughout the chain of custody. The terms “validation” and “qualification” are used interchangeably and loosely at times.
eBook
Defense in Depth – Off-Site Storage of Biological Specimens and Biopharmaceuticals for Risk Mitigation
The management of risk is part of all business operations, but to commercial biobanks, clinical research institutes, biotech, and pharmaceutical companies, risk mitigation is a critical element of day-to-day operations. The costly nature of irreplaceable samples/cell lines and high value products such as cell-based drugs, and biological active pharmaceutical ingredient (Bio-API) dictates planning for the full continuum of risk. The best solution is frequently off-site storage.
eBook
Thinking Outside the Freezer: DNA and RNA Storage
Download this ebook to learn alternative solutions for DNA and RNA storage options.
eBook
Safely Transporting Medicines to Patient: De-Risking the Supply Chain
Download this eBook to view the survey results and accompanying analysis about what it means to pick the best pharmaceutical logistics partner.
eBook
Cell Therapy Logistics: Advanced Therapy
Overview key considerations for developing a successful logistics strategy for the management of cell-based material.
eBook
Flexibility Enables Managing Large Leaflet on Automatic Packaging Line
A large multinational pharmaceutical company asked the Thermo Fisher Scientific Ferentino site to fix an issue that resulted from a change request to increase the size of the product information leaflets. These leaflets were important and required for regulatory and marketing reasons. Download the case study to learn more.
eBook
Cold Chain Shipping Considerations
Overview cold chain shipping considerations, examine different temperature controlled packaging options and learn the advantages/disadvantages of various coolants.
Case study
Collegium Pharmaceutical’s Approach to Abuse Deterrence Breaks New Ground
The opioid abuse epidemic is a serious public health crisis that demands action on the part of many stakeholders. While abuse-deterrent opioids will not solve the opioid abuse epidemic alone, they play a critical role in the fight against it. While Collegium had come up with an innovative new approach to abuse deterrent formulations, it did not have the capacity or resources to manufacture its drug on a commercial scale.
Brochure
Softgel Technologies Overview
Thermo Fisher brings value to pharmaceutical and consumer health care companies through ideation sessions and flexible business models that can: Develop product Proof of Concept to confirm market interest,...
Brochure
Leading Viral Vector CDMO Services for Cell and Gene Therapies
With 14+ years of experience in viral vector services, Patheon is your end-to-end viral vector CDMO partner from process and analytical development to clinical and commercial supply of viral...
Brochure
Biopharma Capabilities Overview
Learn more about our integrated offering for biopharma organizations. Built on a foundation of quality systems and commitment to continuous improvement, we help you achieve success at every milestone.
Brochure
Quick to Care™️ program
Discover how the Quick to Care™️ program can help take months off the development timelines of your large and small molecule discoveries. The program streamlines your drug substance and...
Brochure
Rx softgel solutions: Find the right dosage form to suit your molecule
Choosing the right partner to develop your Rx softgel drug can be a difficult decision. Whether your product has solubility issues—like 70% of drugs in development—or requires abuse-deterrent technology,...
Brochure
Small molecule API solution: Taking a big picture approach
With competitive options for API outsourcing in all geographical regions, it can be difficult to choose the right partner for your project, regardless of its complexity. Thermo Fisher Scientific...
Brochure
Steriles drug development and manufacturing: Flexibility and optimization
The rapid 10 percent growth of sterile drug product over the past five years has resulted in the need for capacity and innovative solutions within development and manufacturing. Navigating...
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Oral solid dose – Access a range of flexible drug development & manufacturing solutions
Navigating a complex regulatory environment, analytical data, process development and optimization, and on-time delivery are all vital to the success of your OSD drug product. Thermo Fisher Scientific provides...
Brochure
5 Ways Your Viral Vector Manufacturing Partner Should Make You Feel
5 Ways Your Viral Vector Manufacturing Partner Should Make You FeelIn viral vector manufacturing for cell and gene therapies, success requires a level of commitment and dedication that makes...
Brochure
Developing a CMC and regulatory roadmap for your molecule’s lifecycle
Getting your strategy right from the start of your molecule’s journey can help save time and money as you advance through each phase and proceed to commercialization.
Brochure
Oral Solid Dose for Oncology
Thermo Fisher Scientific offers robust drug substance, drug product, and clinical trial supply solutions to scale your small molecule all under one roof.
Case study
Development of Qualified Cold Chain Solution for Vaccine Transport to Uganda
A government contractor required the development of a repeatable and effective pack out which could maintain steady temperature of 2°-8° C (35°-46° F) during transit for the transportation of vaccines (varying payloads) which were shipped to Uganda as part of a study. This was quite challenging given the logistical challenges that exist given the remoteness in access.
Case study
Cost Savings and Speed: The Untapped Value of a Single-Source Solution
Learn how one small company took advantage of our Quick to Care™ solution to streamline its drug development and expedite the path of molecule to commercial drug product.
Case study
Clinical Supply Optimization: Mid-Sized Pharma Embraces Forecasting
With no solid demand planning due to understaffing, a mid-size pharmaceutical company ran into serious trouble with stockouts and incorrect drug shipments that threatened to jeopardize its clinical trial program. Learn how Thermo Fisher quickly assessed the issue and reconfigured the interactive response technology to start producing accurate forecasting statistics, thereby saving the program.
Case study
Packaging Design Provides Time and Cost-Efficiencies for a Growing Biopharma Company
Learn more about the process of designing a blistering package project that delivered an optimal, cost-effective solution for a growing biopharma.
Case study
Automation Slashes Turnaround Time for Clinical Trial Labeling
Find out how a radical reduction in the time it takes to produce clinical trial labels was realized for a multinational trial.
Case study
Cold Chain Reusable Shipper Reduces Risk and Waste
Learn how a multinational pharmaceutical company found itself face-to-face with a sustainability challenge and turned to a new shipping solution, reusable shippers, to help them reduce their waste and carbon footprint.
Case study
Clinical Packaging: Process Overhaul Cuts Cycle time by 55%
Learn how lean manufacturing techniques, label modifications and operational improvements helped support clinical trials of a blockbuster oncology drug.
Case study
Clinical Supply Global Optimization
Read this case study to gain insight into how to smooth the execution of your distribution strategy and ensure all your patients have the right medication on time.
Case study
How a global network enabled distribution of an oncology drug to 60,000 patients in 35 countries every month
Angie will never forget the day she got a call from a client with a packaging and logistics challenge of global proportions. They needed help figuring out how to get an oncology drug labeled for 60,000 patients in 35 countries every month. And they needed that solution to fit in a four-week cycle. Read the case study to learn how the team reduced the cycle time in half.
Case study
How overcoming barriers ensured on-time delivery of a life-changing medication
A new drug made in Canada. Shipped to Mexico. Now needed in Brazil. If the client didn’t make this launch, the region would have lost all access to this medication. Download this case study and see how one team’s experience cracked the code.
Case study
Delivering Clinical Trial Medications Direct-to-Patient
Download this case study to learn how Thermo Fisher Scientific was able to provide Direct-to-Patient services to meet a critical need.
Case study
Global Ultra-Cold Clinical Trial Logistics
The Challenge: A new United States-based biopharma working on its first cell therapy-based treatment had expanded the scope of their trial and extended its patient pool to include a patient in Beijing, China.
Case study
Expedited Import of Zika Virus Test Kits Enable Vital Research
Given the rapid and widespread outbreak of this virus, researchers were urgently working towards a solution. In a significant breakthrough, a European-based manufacturer had successfully developed a test kit that enabled serological detection of the Zika virus. Getting these kits into the labs of the United States researchers became a critical priority.
Case study
Direct to Representative Sample Distribution Services
Learn how we helped a manufacturing company design an efficient sample distribution program to minimize product loss, while ensuring full compliance with industry regulations.
Case study
Managing Clinical Ancillary Supplies at a Global Scale
Follow a biopharmaceutical company entering a Phase III trial that included 45 countries and an enrollment target of 4,000 patients in a randomized, double-blind, placebo-controlled study.
Case study
How an emergency IND was able to reach a patient in under 12 hours
It’s Saturday. A six-day-old baby needs emergency medication. You need a team that’s prepared for situations like this to turn two and a half days of logistics into just 12 hours. Download this case study to learn how Holli and her team made it happen.
Case study
We work together to meet global demand for COVID-19 vaccines
Learn what led to Thermo Fisher Scientific looking for a bespoke packaging solution, one that enabled work to be carried out within the low temperatures and specific timescales needed
Brochure
Global clinical supply solutions for every trial delivering the right drug to the right patient, on-time, in-full, and without compromise
In the highly competitive, new drug development market, biopharma companies face a myriad of challenges—from balancing cost, time, and quality, to delivering the best possible outcome for their...
Brochure
OTC softgel solutions: Give your branded product a competitive advantage
Thermo Fisher Scientific can offer innovative ideas on brand expansions via our own softgel technologies that can give your branded product a competitive advantage—helping you stand out to consumers....
Brochure
From Molecule to Medicine
Patheon, part of Thermo Fisher Scientific, is transforming the way pharmaceuticals are made with a simplified, end-to-end supply chain for pharmaceutical and biopharmaceutical companies of all sizes. Learn how.
Brochure
Pharma Services EMEA network, integrated network from molecule to medicine
Our objective is to help speed your molecule through early phase trials and prepare you for commercial success, faster. In this brochure, find out more about our dedication and...
Case study
Fighting The Opioid Epidemic: How Grünenthal’s Abuse-Deterrent Technology Contributes
Learn how Grünenthal overcame various manufacturing challenges and utilized the expertise of a CDMO to develop its abuse-deterrent formulation, INTAC®.
Case study
Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product
Learn how our stepwise approach to Quality by Design (QbD) became integral to the success of the Amylyx Pharmaceuticals AMX-0035 campaign.
Case study
Clinical supply optimization enhanced services – process improvement reduces study startup phase by 40 percent and drives improved supply chain execution
Clinical supply optimization enhanced services – process improvement reduces study startup phase by 40 percent and drives improved supply chain
Case study
Clinical supply optimization – investigator supported studies streamlined
The key to a successful program of investigator supported studies is maintaining productive relationships with the physicians at the clinical sites.
Case study
Clinical supply optimization – enhanced service model saves trial sponsor time on supplies
The vice president of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager.
Case study
Clinical supply optimization – digging for the true cost of clinical supply
Pharmaceuticals are a small part of this company’s overall business and its team was relatively new to clinical supplies.
Case study
Clinical supply optimization – clarifying the relative risk of change
The clinical team at this top ten pharmaceutical company struggled with the delicate balancing act between controlling the costs of a major oncology trial and making strategic investments that would pay off in the long term.
Case study
Clinical ancillary supply management – streamlining ancillary supplies and the investigator experience
A top 25 global pharmaceutical company came to Thermo Fisher Scientific requesting support for a complex global program encompassing 15 studies across 53 countries over 1,000 sites and for over 12,000 patients.
Case study
Clinical ancillary management – tackling the complexities of a global diabetes trial
A large manufacturer needed support for their global diabetes trials. The scope of a single trial often included as many as 1,500 to 2,000 patients in 15 to 20 countries across all geographic regions (US, EU, Asia, Middle East).
Case study
An alternative logistics approach realizes cost and performance efficiencies in Asia Pacific
A top major pharmaceutical company with research priorities aligned to significant global health needs had a high number of studies in progress in the Asia Pacific region.
Case study
Accessing patient populations in remote locations presents challenges for ambitious new trial
A top major pharmaceutical company needed guidance on how to run an ambitious clinical trial in the Asia Pacific region involving 10+ countries, 74+ sites with 400+ shipments across the region.
Case study
Total Transportation Management Saves Company $10.2M
Learn how a multinational pharmaceutical company optimized transportation costs, maximized on-time, in-full delivery to all global locations and delivered enhanced site satisfaction.
Case study
The Criticality of API CDMO Selection: Insights from a Client
Small and emerging companies face challenges related to limited funding and resources, such as technical expertise and capacity, making it imperative they find a competent partner to support them. Learn why 4SC selected Thermo Fisher Scientific Pharma Services as their CDMO partner to develop its lead asset, resminostat.
Case study
The Critical Importance of Comparator Temperature Excursion Management: A Robust Quality Assurance Process
Learn how Thermo Fisher helped two clients to overcome comparator sourcing challenges and avoid costly delays in their clinical trials.
Case study
Not Just A Vendor, But Part Of The Team
Learn how the Clinical Label Services team helped an emerging biotechnology company reduce cycle times and ease the burden of lengthy clinical timelines and unhappy sites.
Case study
Meeting Milestones and Patient Needs Through Expedited Delivery of Phase I Materials
Learn how Reneo Pharmaceuticals got to clinic in 14 weeks from delivery of their API with the Quick to Clinic™ for Oral Solid Dose program.
Case study
How to Select the Best Courier Around the Globe
Get an in-depth look at the clinical trial challenges faced by a world leader in biotechnology and the actions taken to realize surprising results.
Case study
How Pacira Pharma is Working To Help Curb The Opioid Epidemic
Poorly managed postoperative pain can have a significant impact on a patient’s recovery. Consequently, more patients relying in opioids furthers compounds the opioid epidemic. This case study discusses how Patheon and Pacira Pharma partnered to help curb this epidemic.
Case study
How a Best-Practice Strategy for Sourcing Ancillary Materials Reduced Risk, Spending and Workload in a Global Diabetes Trial
Learn how a sound strategy and solid execution plan enabled this company to overcome the challenges they faced to ensure that their patients received the ancillary products they needed.
Case study
High Precision Syringe Labeling
Discover how high precision labeling helped a customer who had to blind their syringe against commercial drug product by applying a label containing a dosing scale to syringes of varying lengths.
Case study
Flexibility Enables Managing Large Leaflet on Automatic Packaging Line
A large multinational pharmaceutical company asked the Thermo Fisher Scientific Ferentino site to fix an issue that resulted from a change request to increase the size of the product information leaflets. These leaflets were important and required for regulatory and marketing reasons. Download the case study to learn more.
Case study
Early Licensure of a Breakthrough Cancer Drug Gives Hope to Patients
This compelling case study outlines how a multinational pharmaceutical company worked with a cross-functional Fisher Clinical ServicesSM team to deliver clinical supplies to treat an aggressive form of skin cancer, Merkel cell carcinoma.
Video
The Medicine Maker, Chapter 1: Understanding Industry Shifts
Video Webinar with The Medicine Maker, Chapter 1: Understanding Industry Shifts.
Video
The Medicine Maker, Chapter 2: Overcoming Commercial Launch Challenges
Video Webinar with The Medicine Maker, Chapter 2: Overcoming Commercial Launch Challenges.
Video
The Medicine Maker, Chapter 3: Identifying Volatile Forecast Variables
Video Webinar with The Medicine Maker, Chapter 3: Identifying Volatile Forecast Variables.
Video
The Medicine Maker, Chapter 4: Measuring Forecast Accuracy
Video Webinar with The Medicine Maker, Chapter 4: Measuring Forecast Accuracy.
Video
The Medicine Maker, Chapter 5: Planning for Insourcing or Outsourcing
Video Webinar with The Medicine Maker, Chapter 5: Planning for Insourcing or Outsourcing.
Video
The Medicine Maker, Chapter 6: Leading Industry Transformation
Video Webinar with The Medicine Maker, Chapter 6: Leading Industry Transformation.
Video
Clinical and Commercial Manufacturing for Oral Solid Dose in Greenville, North Carolina
Clinical and Commercial Manufacturing for Oral Solid Dose in Greenville, North Carolina.
Video
Clinical and Commercial Manufacturing in Brisbane, Australia
Our Brisbane, Australia site is 2014 winner of the ISPE Facility of the Year award and 2015 winner of the Frost and Sullivan APAC CMO of the year award. The site provides scale up and manufacturing services of recombinant proteins and monoclonal antibodies.
Video
Collaboration and Knowledge Transfer Equals Success for Patients
Collaboration is an important part of our culture at Thermo Fisher Scientific and it starts with our people. Emily and Jessica are a great example of how a mentor relationship facilitates the transfer of critical knowledge to achieve long-term results.
Video
Continuous Manufacturing in Patheon’s Greenville, North Carolina Site
We are the first CDMO to build and manufacturing client product on a continuous manufacturing line. The suite, located at the site in Greenville, North Carolina, is custom built to utilize the best equipment available.
Video
Delivered With: A Positive Client Experience
Learn how a global CDMO never loses sight of what’s important to our clients.
Video
Delivered With: Partnership and Passion
Learn why this supply chain executive calls Thermo Fisher Scientific the CDMO partner of choice.
Video
Early Development and Oral Solid Dose in Milton Park, UK
Discover Thermo Fisher Scientific’s formulation and clinical manufacturing site in Milton Park, UK featuring proven expertise in early development and oral solid dose.
Video
Fisher Clinical Services & Patheon: Better Together
Leon Wyszkowski, President, Commercial Operations, discusses the value of Patheon and Fisher Clinical Services joining together to provide integrated solutions for our clients.
Video
Flexible Oral Solid Solutions From Early Development to Commercial Manufacturing
Thermo Fisher Scientific provides a range of flexible oral solid dose solutions that can help you easily address your small molecule’s unique needs and challenges from early development to commercial manufacturing.
Video
Going the Extra Mile is Part of Our DNA
The stakes were high for a client who needed material for a novel drug to in order to proceed to clinical trial. With millions of dollars on the line, Jeff’s team had one shot to develop a process to scale up or risk failing the batch.
Video
How a Combination of Medicines Helped One Man Take Back His Life, and Inspired Us All
On a quiet Sunday afternoon, Pete and his wife Lisa took a moment to sit on a porch swing and relax. A small piece of wood holding the chain broke and they fell backwards causing Pete to break his neck.
Video
How a Family’s Perseverance Helped Them Reach a Seemingly Unattainable Goal
As members of the United States Air Force, Lauryn and Chris were as healthy and fit as a young couple could be. But in the world of genetics, all it takes is a couple of proteins lining up in the wrong way, and things can change in a hurry.
Video
How a Small Non-profit Teamed up with a Global Manufacturer to Bring Their ALS Drug to Clinical Trials
Before she lost her own battle to ALS in 2003, Jenifer Estes started Project ALS, raising over $17 million dollars for the non-profit in hopes of a breakthrough in the fight against Lou Gehrig’s disease. As her family continued the quest, in 2019, they got a hit with a new compound that seemed to stop or even reverse motor nerve damage.
Video
How a Viral Vector Got the Boost It Needed to Start Defeating an Incurable Disease
Duchenne’s Muscular Dystrophy is an incurable disease that mostly affects boys. It results from a gene defect that prevents those affected from developing normal muscle structure and function.
Video
How Can Pharma Companies Save up to $45M in Early Drug Development?
Patheon’s Jennifer Therrien discusses findings of a Tufts Center for the Study of Drug Development (CSDD) study that reveals how pharmaceutical companies using a single-source outsourcing partner can achieve a net gain of $45 million in early drug development.
Video
How Embracing Flexibility Creates Success for All
Learn how Whitney took on the challenge of creating more flexibility within existing rigid processes to better meet the needs of her client. Together, they came up with a solution to optimize critical paths forward to expedite getting life-saving therapies to the patients who need them.
Video
How Leveraging a Global Network Delivered Big Results
Mike’s team in Bend, OR was only supposed to optimize the spray drying process for a particular medication while another, much larger, facility would handle the large-scale manufacturing. However, the other facility’s equipment wouldn’t be available in time to meet the client’s aggressive IND filing schedule.
Video
How One Brave Patient Went from the Heart Transplant List to Climbing the Mountain Trails
“It felt like getting kicked in the chest by a horse.” That’s how Linda described the shock she received from her implanted defibrillator when she had one of her yearly “mini heart attacks.”
Video
How One Split-Second Decision Made a Difference for Thousands of Patients
In the world of drug manufacturing not all life-saving decisions happen in the lab. Sometimes it’s a lot closer to delivery that key moments require fast thinking.
Video
How Speaking a Third Language Helped Win the Race to Market
Several Chinese pharmaceutical companies were competing to be first to market. And second place didn’t matter.
Video
How Spring Break Had to Wait a Little Longer, So a Baby Could Have a Better Shot
After a long night of packing for her family’s spring break vacation, Holli woke up at 4:40 AM Saturday morning. She noticed a text message on her phone.
Video
How Thermo Fisher is Battling COVID-19
We are proud to be on front lines arm-in-arm with our clients, fighting COVID-19. Together, we will win. Every patient matters.
Video
How two college kids took a dorm-room idea all the way to clinical trials.
Watch the video to learn why companies like Amylyx are choosing to partner with Thermo Fisher Scientific for their outsourcing needs.
Video
How Viral Vector Technology Is Rapidly Scaling up to Enable One Miracle After Another
The promise of viral vectors has been pursued for over two decades. But in the last few years, this transcendent technology that’s targeting over 200 diseases has finally started to create real treatments and possible cures.
Video
Made For: Hope for ALS
Learn how Amylyx Pharmaceuticals partners with Thermo Fisher Scientific to bring hope to patients with ALS.
Video
One Bottle of Hope for One Amazing Kid
Meet Gavin and his mom, Nicole. Learn how Gavin’s battle with a brain tumor led him to the bottle of hope that allowed him to be a kid again.
Video
Our Formulation of Heart and Science is the Key to Our Success
At Thermo Fisher Scientific, everything we do is made with the right balance of heart and science. Find out how Angie and our Fisher Clinical Services team went above and beyond to overcome tough obstacles in order to ensure thousands of patients around the globe received life-saving medications.
Video
Patheon’s Softgel Expertise
Learn more about the Softgel expertise at Patheon, by Thermo Fisher Scientific.
Video
Quick to Clinic™ for Oral Solid Dose
Learn how Reneo Pharma was able to get to clinic in 14 weeks from delivery of their API.
Video
Single-Use Technology for Biologics Manufacturing in St. Louis, Missouri
Learn about Thermo Fisher Scientific’s expansion of its biologics site in St. Louis, Missouri. The facility will be the single largest single-use technology CDMO in the United States.
Video
Softgel Manufacturing in High Point, NC
Discover how softgels present a viable option to help achieve drug solubilization, allowing enhanced absorption and bioavailability.
Video
Solubility Center of Excellence in Bend, Oregon
Discover Thermo Fisher Scientific’s early development site in Bend, Oregon, featuring proven expertise in solving solubility challenges for clients.
Video
Solved With: Capacity and Compassion
Learn how Thermo Fisher Scientific was able to help this company solve one of their biggest challenges in the drug development process.
Video
Step Beyond with Thermo Fisher Scientific
To serve science, Thermo Fisher Scientific needs to stay ahead of it. To be the world leader in serving science, we need to anticipate customer needs.
Video
Sterile Drug Product Development and Manufacturing In Greenville, North Carolina
Meet the team and tour our Greenville, North Carolina manufacturing facility, which a focus on sterile drug product development and manufacturing.
Video
Sterile Vial and Prefilled Syringe Fill-Finish in Monza, Italy
Take a look inside Thermo Fisher Scientific’s sterile fill-finish manufacturing site in Monza, Italy. The site currently manufactures commercial supply, but has recently invested $50 million in sterile drug development capabilities.
Video
The “Eureka Moment” That Helped a Small Company Make a Big Impact
Tony and the team at Thermo Fisher Scientific understand the needs of small and emerging companies.
Video
The Journey from Molecule to Medicine
It all starts with your discovery. A molecule, small or large, that needs a partner. Let Patheon be that partner.
Video
Thermo Fisher Scientific & CSL Enter Strategic Partnership to Provide Best-in-Class Pharma Services
We are pleased to announce that Thermo Fisher Scientific and global biotechnology company CSL have entered into a strategic partnership to help meet the growing demand for biologic therapies while also accelerating CSL’s broader manufacturing objectives.
Video
Vectoring In — Viral Vector Video Series
Preparing cell and gene therapies for regulatory submission
When preparing to ramp up late stage manufacturing for commercialization, understanding key critical to quality parameters will help prepare your therapy for regulatory submission.
Video
You Inspire Us Every Day
Michel Lagarde, Executive Vice President, Thermo Fisher Scientific, discusses why Pharma Services employees are so passionate about partnering with small and emerging biopharma clients.
Interview
Insider insights – Q&A with Tom Holmes of Amylyx Pharmaceuticals
Tom Holmes, shares more about their experience teaming up with Thermo Fisher Scientific to manufacture their product.
Brochure
Biologics Overview: Flexible Biomanufacturing Solutions
Your molecule has the power to change lives and shape the future. Patheon is the company that offers you the agility and speed to help you get there ahead...
Brochure
Clinical Trial Supply Solutions
Learn how our global team can meet the needs of every trial regardless of size, phase or therapeutic area.
Brochure
Transportation Solutions for Cell and Gene Therapy Supply Chains
Learn key considerations for evaluating transportation partners for your cell and gene therapy supply chain.
Brochure
Continuous Monitoring Solutions for Cold Chain Logistics
Download this fact sheet to learn about our continuous monitoring solutions for cryogenic shipments.
Case study
Free trade area attracts zone sponsors to India
A top major pharmaceutical company needed guidance on how to run an ambitious clinical trial in the Asia Pacific region involving 10+ countries, 74+ sites with 400+ shipments across the region.
Case study
Expert handling of high-risk clinical trial product in Mexico
A multi-national sponsor needed a reliable provider with a wealth of expertise in delivering highly complex products from point of origin to patients at investigator sites, on time and in perfect condition.
Case study
Clinical supply optimization – mid-size pharma rejects bulk, avoids shortage
Many companies developing biosimilars are not confident in their own capacity to forecast supply needs and manage them on an ongoing basis.
Video
Advantages of Softgel Solutions for Developers
Kaspar van den Dries, Ph.D. discusses the many advantages for drug developers who choose Softgels.
Video
Bioprocessing Collaboration Center (BCC)
The new Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri, uniquely positions Thermo Fisher to bring together industry-leading expertise in single-use technologies and biologics product development and manufacturing to deliver unmatched value to our customers.
Video
Benefits of Working with Patheon Softgels
Kaspar van den Dries, Ph.D. discusses the benefits of working with Patheon for your softgels project.
Presentation
How to pick the right CDMO for latephase clinical trials
For pharmaceutical companies without their own facilities, choosing the right partner for late phase clinical trials and commercial production is a critical consideration in developing parenteral products.
Presentation
Process characterization: Ready for the FDA?
As pipelines evolved to more complex molecules and manufacturing processes, though, the outlook of regulatory agencies on process characterization also changed.
Case study
Supplier collaboration delivers innovative solution for trial sponsor
In clinical trials using interactive response technology (IRT) drug dispensation is normally triggered after site activation or patient screening.
Case study
How clinical trial design impacts the supply chain
A pharmaceutical manufacturer established a head-to-head study comparing the safety and efficacy of Product A and Product B (the competitor’s product) for diabetic peripheral neuropathic pain (DPNP).
Case study
Clinical Ancillary Management, Solutions for Oncology Studies
Learn how to eliminate the need to determine unnecessary site-specific supplies and save months of work for all parties while increasing flexibility in the supply chain.
Whitepaper
Quantification of Vector Genomic DNA and Residual DNA in Gene Therapy Vectors Using ddPCR
To bring life saving cell and gene therapies to the market, an efficient and scalable manufacturing strategy is needed. Learn how to overcome this barrier to commercialization.
Whitepaper
Anticipating the Formulation Challenges of Complex Molecules
Formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs. Find out how to best anticipate formulation challenges of complex molecules and APIs.
Whitepaper
Are You Prepared for the Complexity of Pediatric Drug Development?
The numerous controls and processes in place to ensure a medication is safe, effective, and manufactured with the utmost efficiency make drug development extremely complicated.
Whitepaper
The Pharma Trends You Need to Know: A CDMO’s Perspective
The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development.
Whitepaper
Managing Demand Uncertainty in Biologics Production
For a small company for which liquidity is critical, tying up capital in a fallow facility due to improper forecasting can be catastrophic.
Whitepaper
Solutions to Today’s Biomanufacturing Challenges
Biopharmaceutical companies take on a lot of risk developing new large molecule drugs. With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.
Whitepaper
Consultants’ guide to flexible biomanufacturing solutions
Gain insight into key strategies that consultants can keep in mind for their smaller biopharmaceutical clients.
Whitepaper
Evaluating current manufacturing platforms for recombinant AAV production
Realizing the full potential of viral vector-based therapies requires a successful manufacturing platform for recombinant Adeno-associated virus (AAV) vectors.
Whitepaper
In-House Versus Outsource: A Decision-Making Guide
The biologics market is quickly evolving from a focus on developing blockbuster drugs to exploring niche markets with unmet needs.
Whitepaper
Technology Transfers: Reaping Rewards, Reducing Risks
In 2016, Patheon successfully completed 111 technology transfers to help our clients safeguard supply, improve distribution and reduce program costs and risks.
Whitepaper
Novel Uses for Oral Solid Doses Driving Lifecycle Management Strategies
With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage (OSD) arena.
Whitepaper
Ensuring the greatest return from your poorly soluble molecule
The number of potential strategies for improving the solubility of a compound can overwhelm many developers.
Whitepaper
How to build a robust packaging strategy for rapid commercialization
When initial clinical trial results for a new drug show promise, the focus begins to shift to commercialization and planning for a pharmaceutical packaging strategy.
Whitepaper
5,000L single-use bioreactors: The next generation in biologics manufacturing
As the global biologics market and scientific advancements in biopharmaceuticals continues to rise, so has the demand for therapeutics, expanding indications for biologics, and the growing portfolios of biosimilars.
Whitepaper
Setting a strong foundation for your oral solid dose product to support late-stage development
Lengthy early development timelines are common across new & emerging biotech companies for a multitude of reasons.
Whitepaper
Sterile formulation strategies to shorten timelines for first-in-human studies
Lengthy early development timelines are common across new & emerging biotech companies for a multitude of reasons.
Whitepaper
Navigating the Adoption of Continuous Manufacturing Amid Unprecedented Global Challenges
Continuous manufacturing is an innovative solution, providing flexibility and up to 1.65X scale-up cost savings compared to batch manufacturing.
Whitepaper
Analytical Considerations For Biopharmaceuticals During Commercialization
To ensure the quality and safety of pharmaceutical drug products, it is critical to validate analytical methods before process performance qualification (PPQ).
Whitepaper
Who’s Watching Your Supply Chain? Strategies for Mitigating Risk in Clinical Trials
With the ever increasing costs of clinical trials and the advantages of being first-to-market, it’s time to take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within your budget.
Whitepaper
Challenges and Practical Solutions for Switching to Prefilled Syringes for Injectables
Learn the critical patient benefits and improved outcomes of prefilled syringes, as well as how to select the most appropriate type and how to bridge vials with them.
Whitepaper
Product Development For An Oral Solid Dosage Using Continuous Manufacturing
When bringing a new drug to market, product development is typically aligned with the clinical trial schedule; therefore, as the patient pool grows, so does the supply of drugs needed for the study.
Whitepaper
Key Considerations for Labeling Your Cell or Gene Therapy
Learn ways to safeguard products using viable packaging and labeling strategies for your cell or gene therapies.
Whitepaper
The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing
ORC International's report "Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing" explores the causes, consequences, and potential solutions to forecasting challenges specifically related to biopharmaceutical drug substance manufacturing.
Whitepaper
The Race to Phase III: A Cautionary Tale of Scalability
When aggressive timelines are a “must,” it’s critical that companies don’t gloss over early-phase scale-up throughout the development process.
Whitepaper
Strategies for API Solubility and Bioavailability Enhancement
The landscape of today’s drug development industry looks far different than it did only a decade ago. Innovation is creating exciting new possibilities in patient care.
Whitepaper
Is Your In-House Strategy Ready for the Uncertainties of Biologic Drug Development?
The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include a focus on developing drugs that treat the unmet needs of smaller patient populations.
Whitepaper
Six API Challenges That Could Be Slowing Your Development and How to Avoid Them
Most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
Whitepaper
Rise in Targeted Therapies Drives Need for Small-Volume Manufacturing
Learn what pharma companies should look for when navigating this new era of small-volume manufacturing.