Pharma insights blog
Articles by technical and scientific subject matter experts
Five best practices for integrating drug substance and drug product development
Discover five best practices to consider when integrating drug substance and drug product development to optimize the efficiency and effectiveness of your approach.
9 minute read
CDMO quality harmonization: Ensuring consistency, reliability, and supply chain resilience
The harmonization of quality standards, procedures, and practices across sites is crucial for enhancing the resilience and efficiency of the entire supply chain and is a key driver in accelerating market entry for safe, effective therapies.
14 minute read
What’s hot in freeze drying? Your lyophilization questions answered
Lyophilization is a critical process in the sterile fill-finish phase of pharmaceutical manufacturing, particularly for products that require high levels of stability and a longer shelf life. The ability to transform drug products into a dry powder without compromising their structural integrity is particularly crucial for preserving the stability and efficacy of biologic products, such as vaccines, antibodies, and other protein-based therapies. Over the years, advancements in technology and process optimization have made lyophilization more efficient and reliable for a wide range of pharmaceutical applications.
15 minute read
Revolutionizing drug development: AI-driven solutions for solubility and bioavailability challenges
The integration of AI/ML technologies in drug development, particularly in addressing solubility and bioavailability challenges, marks a significant paradigm shift in the pharmaceutical industry. These advanced computational methods are transforming the traditional resource-intensive trial-and-error processes into more efficient, accurate, and cost-effective strategies.
12 minute read
Mastering complex small molecule APIs and formulations
Complex small molecule APIs are characterized by their intricate structures, higher molecular weights, and sophisticated delivery requirements, which pose unique challenges in their formulation and manufacturing processes.
15 minute read
Predictive modeling for solubility and bioavailability enhancement
Explore the challenges faced by poor solubility and low bioavailability in pharmaceutical formulation and the potential of predictive modeling to overcome these challenges.
15 minute read
The quality lever: Shaping success in CDMO partnerships
Compromising on quality can lead to detrimental impacts on both speed and cost, ultimately affecting the successful development and marketing of new therapies.
10 minute read
Blog post
A CDMO Partner for every Gene Therapy Manufacturing Stage
Take a closer look at the experiences of NysnoBio and bluebird bio for insight into what companies need in a CDMO partner for every stage of viral vector manufacturing and development.
20 minute read
Blog post
CDMO 2.0: Three pharma industry trends for 2024 and beyond
Discover three major trends expected in the pharma industry, including turning to flexible manufacturing, embracing digital enablement, and the need for CDMOs deliver transformational value.
15 minute read
Blog post
Benefits of an integrated approach to viral vector manufacturing
Learn why biopharma companies choose to partner with integrated CROs and CDMOs with experience developing and manufacturing viral vectors over doing the work in-house.
15 minute read
Blog post
Understanding the viral vector product journey
Learn why biopharma companies choose to partner with CDMOs to leverage their innovative, integrated, and ready-to-use solutions for viral vector development and manufacturing for gene therapies.
20 minute read
Blog post
Exploring four patient-centric trends shaping today’s biopharma landscape
The biopharma industry is adopting a patient-centric approach to drug research, development, and manufacturing. Explore four trends shaping today’s landscape.
15 minute read
Blog post
Sterile injectable therapies: Changing delivery formats revolutionizes lifecycle management
The sterile injectable drug market is evolving at a rapid pace. This segment's significance cannot be understated. A closer examination reveals the intricacies of this evolving landscape, specifically in the realm of delivery formats.
8 minute read
Blog post
Key Insights from CPHI Barcelona 2023
As the largest global event for pharmaceutical supply chain companies, CPHI is a microcosm of the pharmaceutical manufacturing industry. At this year’s event, the rapidly shifting pharma landscape contributed to an undercurrent of urgency. Following are some of the key takeaways.
10 minute read
Blog post
Inside pharmaceutical formulation development
Pharmaceutical formulation is a key aspect of drug development and helps to ensure safe, effective, and patient-friendly medications for people worldwide.
15 minute read
Blog post
Unlocking efficiency: Pros and cons of outsourcing your biorepository
When it comes to biorepositories, should biopharma companies insource or outsource their storage needs? This blog breaks down the pros and cons.
8 minute read
Blog post
Building a biorepository: Weighing the benefits and drawbacks
Biorepositories play a crucial role in collecting, preserving, and utilizing biological materials, but does it make sense to build or buy one?
8 minute read
Blog post
The 5 drug development phases
To be deemed a “success,” a new drug must make it through five specific phases: 1) discovery and development, 2) preclinical research, 3) clinical research, 4) FDA review, and 5) safety monitoring.
9 minute read
Blog post
Adherence and Accuracy: Smart packaging advances quality in clinical trials
Learn from Thermo Fisher Scientific’s head of medication adherence and biomarker measurement about data-quality implications of smart packaging and how to integrate them into clinical trials.
15 minute read
Blog post
In Silico Modeling: Accelerating drug development
In silico modeling, both in early development and across the product lifecycle, can streamline drug development and reduce the risks associated with trial-and-error experimental methods. Realizing the potential of the technology requires careful selection and application of in silico strategies and a deep understanding of how to interpret and derive the most valuable insights from the data.
6 minute read
Blog post
Integrated CDMO for Small Molecule Drug Development
A single CDMO partner that offers integrated API, drug product, and clinical strategy activities can streamline and accelerate small molecule drug development. Learn more.
6 minute read
Blog post
A collaborative approach to viral vector development and manufacturing
The development and manufacturing of viral vectors from discovery to commercialization is a complicated endeavor with several key considerations. Learn more.
9 minute read
Blog post
Enter the CRDMO: Reshaping drug development through CRO/CDMO integration
CRDMOs, or integrated contract research, development, and manufacturing organizations, are a trend to watch. Discover five benefits of partnering with one.
9 minute read
Blog post
Role of mRNA Encapsulation
mRNA must be encapsulated in different carriers/vectors, such as lipid nanoparticles, to ensure its efficient and effective delivery into target cells. Learn more.
10 minute read
Blog post
mRNA Purification Methods and Process
Learn more about the process of purifying mRNA, and how a CDMO partner with end-to-end mRNA purification experience can help streamline the drug development journey.
10 minute read
Blog post
CROs vs CMOs, and CDMOs: What’s the difference between the three?
CROs, CMOs, and CDMOs all help biotechnology and pharmaceutical companies with drug development and manufacturing, but what’s the difference between the three?
9 minute read
Blog post
Product and partnership quality in viral vector manufacturing: Your gene therapy depends on it
Viral vectors are inherently complex to produce at scale, requiring a laser focus on quality to ensure the efficiency, safety, targeted delivery, and scalability of the gene therapy.
7 minute read
Blog post
What is a CDMO and what to look for in a partner
Learn how CDMOs (contract development and manufacturing organizations) work with pharma companies, and the top considerations companies have when choosing a CDMO partner.
9 minute read
Blog post
Viral vector commercialization – Part 3: Specialized regulatory support
Find detailed regulatory considerations when preparing viral vectors for commercialization and best practices to address them.
7 minute read
Blog post
Viral vector commercialization – Part 2: Best practices in process validation lifecycle
Learn more about the robust viral vector process validation cycle, which includes various assessments and studies to ensure the safety, efficacy, and quality of viral vectors.
11 minute read
Blog post
Viral vector commercialization – Part 1: Tech transfer process for commercial viral vector manufacturing
Learn how tech transfers can help develop and manufacture viral vectors at scale, accelerate vaccine and gene therapy commercialization, and provide expertise.
9 minute read
Blog post
Patheon Translational Services Advance Cell and Gene Therapies from Research to Clinical Trials
Learn how our translational research services, housed in our San Diego facility, can take cell and gene therapies from preclinical to clinical.
6 minute read
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
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
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
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
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
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
Blog post
The Four Stages of Equipment Qualification
As discussed in my previous blog, qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use.
3 minute read
Blog post
Myths & Facts about Ancillaries
It’s a fact that ancillary supplies are frequently perceived as less important than study drug.
2 minute read
Blog post
Is Your Supply Chain Bulletproof?
Before you respond, think hurricanes, Nor’easters and tsunamis. Earthquakes, typhoons and volcanic eruptions. Civil unrest and war. Terrorism. A pandemic virus.
2 minute read
Blog post
Top Tips on How to Manage Clinical Label Translation and Regulatory Requirements
Wouldn’t it be nice to find a way to stay on top of label translation and regulatory requirements for every country included in your clinical trial?
2 minute read
Blog post
Introducing an Expanded Packaging Service for Specialty Products
Developing a specialty drug for a complex or rare disease is an achievement worthy of celebration.
2 minute read
Blog post
Is it Time to Start Thinking about Packaging?
If this headline caught your eye, it may be because you’ve received promising pre-clinical results (Congratulations!) and you’re starting to think about planning your next steps.
2 minute read
Blog post
Taking Your API to the Next Level: Three Steps to Consider Before Outsourcing
With outsourcing API development becoming more common, we see a rise of multiple competing Contract Development Manufacturing Organizations (CDMOs) as potential development partners.
10 minute read
Blog post
Break Through the OTC Noise
It’s no secret—consumers have a vast range of OTC options at their favorite in-store or online retailer. Everything from tablets and capsules, to syrups—consumers have more options than ever in the OTC jungle.
8 minute read
Blog post
Considerations and roadblocks that stifle orphan drug development
According to the US Food and Drug Administration (FDA), “2020 was a record-breaking year in terms of the number of orphan drug designation and rare pediatric disease designation requests submitted to the Office of Orphan Products Development.”
6 minute read
Blog post
Regulatory landscape in Europe: Key advice for meeting post-Brexit Qualified Person requirements
The United Kingdom’s (UK) departure from the European Union (EU) has added a layer of complexity to the clinical trial supply chain in Europe above and beyond COVID-related disruptions.
(4 minute read)
Blog post
Time to embrace electronic labels? Potential labeling solutions under the new EU Clinical Trial Regulation
The new EU Clinical Trial Regulation (CTR) is intended to simplify clinical trial administration and create a more welcoming climate for pharmaceutical companies that operate in Europe.
5 minute read
Blog post
Navigating the Complexities of Process Performance Qualification
Method qualification is monumentally important before process performance qualification (PPQ). This early assessment of your method’s performance characteristics is critical as it pertains to method validation and its parameters such as precision, accuracy, and linearity.
5 minute read
Blog post
Continuous Manufacturing: An Efficient Way to Produce OSD Drugs
When Henry Ford revolutionized manufacturing practices back in 1913 in Highland Park, MI, his main goal was simple—to make the best possible product in the most efficient and cost-effective manner. Ford’s focus on bettering the “flow” of manufacturing to enable workers/technology to work smarter and reduce waste of raw materials, changed manufacturing principles forever.
6 minute read
Blog post
Simplifying Your API's Development Journey
The primary way new drugs are developed is changing. Historically, pharma companies—particularly large pharma companies—have developed APIs in-house.
7 minute read
Blog post
COVID-19’s Silver Lining: Accelerated Vaccine Development
Vaccine development is a lengthy process—it is expensive, attrition is high, and to get a licensed vaccine to everyone, it takes multiple candidate iterations. Vaccine development for pandemics and epidemics is risky, and due to the novel nature of viruses, certain unknown factors can derail a vaccine program.
6 minute read
Blog post
A Day in the Life of a Viral Vector Partner
When it comes to a viral vector Contract and Development Manufacturing Organization (CDMO), what sort of qualities should they possess?
9 minute read
Blog post
How Decentralized Clinical Trials Enhance Patient-Centricity in the Age of COVID-19
As COVID-19 continues to change how we do business in the biopharmaceutical industry, it’s important to not lose sight of why we do what we do: improving and saving patient lives.
5 minute read
Blog post
Work Smarter, Not Harder: Accelerating Your Biologics Development and Commercialization
Over the past decade, the biologics industry has seen double digit growth and an overall increase of market share.
5 minute read
Blog post
Prefilled Syringes: Three Pain Points You May Not Have Considered
As pharmaceutical companies look to become more patient-centric, certain drug products come to the forefront to support that effort.
5 minute read
Blog post
Navigating Cell & Gene Therapy Regulations: How Does Your CDMO Match Up?
Whether you are a large or new and emerging biotech company, many companies find themselves lacking the internal resources and/or expertise to properly support regulatory submissions.
7 minute read
Blog post
Choosing a CDMO Who is a True Bioproduction Expert
With the number of CDMO’s rising in the biologics manufacturing industry, it can be challenging for new and emerging biopharmaceutical companies to determine which CDMO is right for them.
8 minute read