In-House Versus Outsource: A Decision-Making Guide

Author: Barry Rosenblatt, PhD President, SME Biotech Consulting, & Dave Kenyon, PhD Vice President, Process Sciences Pharma Services Patheon, part of Thermo Fisher Scientific
The biologics market is quickly evolving from a focus on developing blockbuster drugs to exploring niche markets with unmet needs. While the changes are exciting, they pose several risks to a molecule’s success as competition intensifies, timelines shorten and capacity challenges emerge. Yesterday’s solutions may not be a perfect fit for today’s molecules. ...View More

Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

Author: Dave Kenyon, Sr. Director, Scientific and Technical Affairs
Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market quicker than ever before. The incentive of securing market share with first-to-market offerings is felt by all industry players. Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. Learn key strategies for speeding time to clinic. ...View More

Managing Demand Uncertainty in Biologics Production

Author: Steve Lam, Senior Vice President, Biologics & John Ward, Vice President, Engineering
Forecasting demand is a complex endeavor. For instance, it’s not unusual for the forecasted and actual dosage of a product to vary by a factor of as much as three. Obviously, that makes a big difference to a demand forecast. If a manufacturer has built capacity in anticipation of a new product and its clinical trial is delayed (for any number of reasons), that manufacturer’s capital is tied up in a fallow facility. For a small company for which liquidity is critical, that can be catastrophic. ...View More

Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?

Author: John Ward, Vice President, Engineering, Patheon
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. These niche drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade, from a low of 10 percent to a high of 27 percent. By 2022, 50% of the value of the top 100 products is expected to come from biologics. ...View More

The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing

Author: Patti Seymour, Senior Consultant | Tom Ransohoff, Principal Consultant Dawn M. Ecker, Consultant | Howard H. Levine, President and CEO
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. This analysis provides further insight and perspective on the key themes that emerge from the report. ...View More

Consultants’ Guide to Flexible Biomanufacturing Solutions

Author: John Foy, Vice President, Business Management, Patheon
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies. This whitepaper is a guide to some key strategies that consultants can keep in mind when working with their clients. ...View More

Top Five Risks Facing Your Small Biopharma Clients Today

Author: Steve Lam, Senior Vice President, Biologics & Jennifer Stone, Vice President, Quality, Biologics
Biopharma firms function in a risky development environment with compressed timelines and budget constraints. Companies often overlook critical factors that could delay or suspend efforts down the road. Consultants should help clients understand five key risks in order to avoid costly problems and maximize financial returns during the development process. ...View More

Challenges, Risks, and Strategies for Biologic Substance Manufacturing

ORC International’s study highlights issues inherent in forecasting biologic drug substances. From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production. The biologics development and approval process is typically long and complicated, increasing the risk of accurately forecasting demand. Overestimating demand can lead to higher per unit cost and disposal expenses, and underestimating it can result in missed market opportunities and negative reputational consequences for the company. ...View More

Solutions to Today’s Biomanufacturing Challenges

Author: John Ward, Vice President, Engineering
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. ...View More

Multiplexing: Managing Risk with Proven, Single-Use Solutions

Author: Marc Goemans
When pharmaceutical companies introduce a new drug to market, they invest enormous amounts of capital, and assume equally enormous amounts of risk. As it usually takes three-to-four years to prepare manufacturing capacity for the large scale production of a new product, the decision as to how much volume a company will need often must be made before Phase III trials are completed. ...View More

Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing - White Paper

Author: ORC International
An Independent Executive Research Study by ORC International examines how large molecule drug substance manufacturing and demand forecasting is riddled with complexity. The long cycle time and short shelf life of a biologic drug substance makes it difficult to adapt the supply chain with agility, even at the earliest stages of development. ...View More

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). As the end point of both the chemical development process and later manufacturing, the quality of the API delivered has a direct impact upon drug product formulation development and manufacturing. ...View More

Infographic: 8 Criteria for a More Successful API Partnership

Outsourcing API development can save time and money. Or it can waste them. Since the difference between these outcomes stems from your choice of a development partner, careful consideration of these eight critical areas is required to help ensure a fast, smooth API development process. ...View More

Six API Challenges That Could be Slowing Your Development and How to Avoid Them

Author: Andreas Stolle, Vice President, Process Development Services, API & Peter Poechlauer, Ph.D., Innovation Manager, API, & Bernt-Dietmar Schober, Senior Business Manager, CBP
The challenges for new drugs looking to enter the market are numerous and varied. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure. ...View More

Accelerate Complex Molecule Development by Optimizing Chemical Synthesis and Formulation

Author: Andreas Stolle, Vice President, Process Development Services, API, Patheon, part of Thermo Fisher Scientific
Peter Poechlauer, Ph.D., Innovation Manager, API, Patheon, part of Thermo Fisher Scientific
Innovations in science and technology over the last few decades enable scientists to create far more advanced pharmaceuticals for today’s industry. As a result, patients rightfully expect medication with fewer side effects and physicians anticipate new and better cures for formerly untreatable diseases. Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication. ...View More

Synthesizing Success: Six Principles for Getting Pharmaceutical Development Right from the Start

Author: Staff, Chemical & Engineering News
The pharmaceutical industry must constantly evolve as companies race to develop the next blockbuster drug. As they face pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. Outsourcing eliminates the need to maintain expensive in-house facilities while providing access to a broad range of different technologies and expertise. A pharmaceutical or biotechnology company looking to outsource its API production has a lot of choices. The growing desire to select one API partner to work with throughout the drug development process, and to potentially also synthesize commercial quantities, puts an increased importance on the selection process. ...View More

What You Need to Know to Avoid Costly Delays in Your API Scale-Up

Author: Peter Poechlauer, Innovation Manager, Patheon
Traditionally, the development of a small-scale synthesis for an active pharmaceutical ingredient (API) and its scale-up to meet the materials demand for clinical trial phases is a sequential activity that passes through multiple sets of hands. Even if the synthesis used at a small scale is the same one used at a large scale, the developer must be prepared to encounter and react to any changes to the API’s quality attributes, such as by-product profile and physical form. ...View More

How Can You Avoid the Fallout From Incompatibility Between Your API and Its Formulation?

Author: Matthew Jones, Sr. Scientist, Head of Crystallization Lab, Patheon
In drug development, designing a formulation for a drug product (a tablet, for example) calls for careful attention to both the physical and chemical properties of the active pharmaceutical ingredient (API or drug substance). It also requires awareness that certain physical attributes, such as particle size distribution of the drug substance, can change with processing conditions and changes in the synthesis route that is employed. Find out how a pharmaceutical company can recognize both unfavorable drug substance properties and incompatibility between an API and its formulation to avoid potential risks to the patient as well as costly interruptions during development. ...View More

Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Author: Anil Kane, PhD, MBA, Global Head of Technical and Scientific Affairs, Formulation, Patheon
Changes in the Drug Substance (DS) process as it scales up can affect the Drug Product (DP). As processes change, many properties of the DS can also change. Therefore, as DS manufacturers evaluate and optimize the synthetic route, process conditions, crystallization solvents, etc., they must understand and track these changes, and discuss them with DP formulators to anticipate challenges in formulation. Learn how collaboration between DS chemists and DP formulators on a formulation development strategy can save time, money, and avoid rework. ...View More

Challenges & Solutions in Cytotoxins & HPAPI

Author: In partnership with Pharmaceutical Technology
We live in a time when breakthrough medicines are being discovered at an unprecedented rate. Yet whether from big pharmaceutical companies or small hubs of innovation, these treatments of tomorrow are often held up by a complex supply chain. Patheon offers a cure. ...View More

Anticipating the Formulation Challenges of Complex Molecules

Author: Anil Kane, Executive Director, Global Head of Formulation Sciences Pharmaceutical Development Services & Andreas Stolle, Vice President of API Process Development Services
Stephen Closs, Senior Director, Global Technical Operations
Formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs. ...View More

Strategies for API Solubility and Bioavailability Enhancement – Selecting Technologies and Excipients

Author: Sanjay Konagurthu, Ph.D., Senior Director, Pharma Services Group, Thermo Fisher Scientific
Tom Reynolds, Principal Scientist, Pharma Services Group, Thermo Fisher Scientific

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. Improvements in synthetic chemistry and high-throughput screening have opened up the small molecule chemical space, leading to novel compounds with the desirable potency. However, they also come with greater solubility challenges.

Download this whitepaper to learn why it is critical that formulation scientists use the most appropriate solubility enhancement technology and formulation strategies to improve the bioavailability of poorly soluble drugs.

...View More

Quality by Design: A Holistic Approach to Drug Development

Author: Anil Kane, PhD, MBA, Executive Director, Global Head of Formulation Development, Patheon, part of Thermo Fisher Scientific
Kaspar van den Dries, PhD, Senior Director and Principle Scientist Solid Dose Development, Patheon, part of Thermo Fisher Scientific
Douglas Rufino. Vice President Global Corporate Quality, Pharmaceutical Development Services, Patheon, part of Thermo Fisher Scientific
As the biopharmaceutical industry continues to evolve, the Quality by Design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. In response to increased interest from global regulatory agencies, QbD seeks to further reduce the risk associated with drug development and bring much-needed therapies to market quicker. ...View More

Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs

Author: Tony Pidgeon, Process Technology Director, Pharma Services, Patheon, part of Thermo Fisher Scientific
Pharmaceutical companies have many options when it comes to selecting a parenteral dosage form for drug product development. Each have their own merits and advantages. Additionally, consideration must also be given to the form of the drug product within the container and the environment in which it will be used and stored. To make the best choice, the pharmaceutical scientist needs to employ a sound development strategy. ...View More

Rise in Targeted Therapies Drives Need for Small-Volume Manufacturing

Biologics have experienced steady double-digit growth over the last 15 years and now comprise slightly more than a quarter of all New Molecular Entity (NME) FDA approvals. Similarly, EvaluatePharma’s 2017 report on orphan drugs projects that by 2020, six of the 10 best-selling global drug therapies will be biologic sterile injectable drugs. Precision medicine is also on the rise, with the FDA approving a record number of precision drugs in 2017. The rise in these targeted therapies means big changes for drug development and manufacturing companies. Learn what pharma companies should look for when navigating this new era of small-volume manufacturing. ...View More

Are You Prepared for the Complexity of Pediatric Drug Development?

Author: Kaspar van den Dries, Ph.D., Senior Director Formulation Sciences, Solid Dosage Forms and Softgels, Patheon, part of Thermo Fisher Scientific
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. The challenges of drug development can increase if a manufacturer assumes an existing formulation for an adult can also be used for a child. Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays and costs to the development process. ...View More

Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact

Author: Anil Kane, PhD, MBA, Global Head of Technical and Scientific Affairs at Patheon, part of Thermo Fisher Scientific
Given the increasing pressure to speed up drug development and make the process more cost-effective, pharmaceutical companies want to ensure that their most promising drug candidates hit the market. However, while speed to the clinic – and then to market – is often thought to be the key to success, it is equally important that formulation, process development, scalability, and stability challenges are addressed by systematic, smart scientific solutions to de-risk the drug development process so that costly late-stage failures can be avoided. ...View More

Novel Uses for Oral Solid Doses Driving Lifecycle Management Strategies

Author: Anil Kane, PhD, Global Head of Technical and Scientific Affairs at Patheon, part of Thermo Fisher Scientific
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. Current areas of exploration include novel drug combinations, oral delivery of large molecules that were available only as injectables, and perhaps most interesting, drugs that carry digital, ingestible sensors that can send information directly to a physician. ...View More

From Molecule to Medicine

Download our 2017 eBook "From Molecule to Medicine" to learn about how Patheon is accelerating drug development and delivery. ...View More

The Race to Phase III: A Cautionary Tale of Scalability

Author: Anil Kane, PhD, Executive Director and Global Head of Technical & Scientific Affairs, Patheon, part of Thermo Fisher Scientific
When aggressive timelines are a “must,” it’s critical that companies don’t gloss over early-phase scale-up throughout the development process. The time and effort spent on risk assessments and thinking about scalability early on will pay dividends in the long run as the path toward regulatory approval is smoother. ...View More

Manufacturing Process Scale-up for Phase III: Clear Sailing or Storms Ahead?

Author: Sanjay Konagurthu, Ph.D, Senior Director of PDS Global Science and Technology, Patheon John W. Burke, Manager of Pharmaceutical Process Technologies, Steriles, Patheon
Regardless of whether your group has been diligently planning for scale-up since Phase I or you have delayed scale-up work until now, it would be a mistake to assume Phase III will be clear sailing. The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process development teams may be. ...View More

Avoid the Do-Over: Why Early Investment in a Scalable Manufacturing Process Is Critical

Author: Enrico Corona, Director of Pharmaceutics & Process Technology and Jonathan Sutch, Senior Manager, Formulation Development
The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs. ...View More

Perspectives on the Future of Drug Development and Delivery

Author: Jim Mullen, CEO, & Many Other Patheon Contributors
We are Patheon, and we bring to bear 40 years of experience and expertise, from development to manufacturing. We also bring global reach. An industry reputation for being right on time, the first time. Supply chain solutions designed to simplify complexity and speed up the process. And a passionate belief that together we can make the world a healthier place. ...View More

Phase Appropriate Formulation Process Design

Author: Anil Kane, Ph.D., MBA
Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development. ...View More

Formulation Development: An Innovative, Simulation-Based Approach

Author: Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD
In order to improve productivity, companies have been leveraging computational chemistry to screen and identify potential drug candidates at the earliest stages of drug discovery. These methods are a viable approach to shortening development timelines and achieving better success. ...View More

How Broadening the Analysis of Compound Factors Allows for Predictive Solubility Solutions - White Paper

Author: Marshall Crew, Ph.D.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. ...View More

Solid Dosage Outsourcing: Mergers, Expansions, and New Technologies

Author: Matthew Knopp
Eric Jayjock, director of continuous manufacturing at Patheon, and Kaspar van den Dries, senior director, formulation sciences, solid dose and softgels at Patheon, discussed outsourcing, mergers and acquisitions, expansion plans and continuous manufacturing in an article published by Tablets & Capsules. ...View More

Solubilization Technology

Author: Sanjay Konagurthu, Ph.D.
The proportion of poorly soluble drug compounds in the development pipeline is on the rise, with 70% to 90% of current pipeline drugs falling in the two low-solubility classes of the Biopharmaceutical Classification System. With the emergence of new techniques to improve solubility, low solubility compounds are more likely to advance to the clinic. ...View More

Evolving CMO-Sponsor Relationships

Franco Negron, senior vice president, North America commercial operations and global integration at Patheon, discussed how the relationship between sponsors and contract manufacturing organizations have evolved into being more strategic and solutions-oriented in an article "Evolving CMO-Sponsor Relationships" published by Genetic Engineering & Biotechnology News. ...View More

Patheon Fosters Innovation and Delivers Industry-leading Service in Brabant

BOM Foreign Investments article "Patheon fosters innovation and delivers industry-leading service in Brabant" features Patheon's Tilburg plant that specializes in the development and manufacture of ‘softgels’- capsules containing liquid doses of medicines and nutritional supplements. The company’s local clients include household names such as Pfizer, Perrigo and Reckitt Benckiser. ...View More

Technology Transfers: Reaping Rewards, Reducing Risks

Author: Thomas Dax, Director External Manufacturing, API, Patheon Mirko Gabriele, Global DPS Technology Transfer Sr. Manager, Patheon Paul Jorjorian, Director Global Technology Transfer, Patheon
In 2016, Patheon successfully completed 111 technology transfers to help our clients safeguard supply, improve distribution and reduce program costs and risks. This has allowed firms to take advantage of specialist expertise, solid processes and standardized operating procedures and equipment. ...View More

Decision Timeline: Considerations in Selecting an Outsourced Solution

Author: Gavin Murdoch, Senior Director, Strategic Partnerships, Global Business Management, Patheon
The traditional business model for in-house pharmaceutical manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market. ...View More

Impact of Incorrect Forecasts on New Product Launches

Pharmaceutical companies around the world are under tremendous pressure – from regulators, legislators, payers, and patients – to reduce the cost of drugs. In response to the outcry for cost-cutting, pharmaceutical company leaders are examining every aspect of their business to determine where they can derive savings, particularly when planning for the launch of a new product. ...View More

Solving the OOS Problem with Continuous Manufacturing

Author: Eric Jayjock, PhD
The goal of Pharmaceutical Process design has long been to implement a fixed process that can produce on-spec materials, which can be confirmed by quality testing. ...View More

Operational Excellence: In a Flexible Manufacturing Environment

Author: Franco Negron, President, Drug Product Services
One of the most critical elements for a pharmaceutical company launching a new drug product is forecasting market demand. Countless variables such as the competitive landscape, reimbursement and market acceptance, influence and contribute to how well a drug performs on the market. Franco Negron, President of Drug Product Services at Patheon, reviews the requirements to operate efficiently in a flexible manufacturing environment. ...View More

Built To Fail: How Today's Manufacturing Options Leave Pharma At Risk

When planning for the commercialization of a new product, pharmaceutical manufacturing executives must plan for capacity needs very early in the process. Download this whitepaper to learn about key variables that manufacturing executives should consider when evaluating flexible manufacturing solutions for commercial manufacturing projects. ...View More

Does Demand Forecasting Keep You Awake at Night?

Author: James Mullen
James Mullen, CEO of Patheon, discusses the demands of pharma forecasting in an article "Does Demand Forecasting Keep You Awake at Night?" published by Life Science Leader. ...View More

Case Study: Cost savings and speed from a single-source solution.

In small pharmaceutical start-ups, you have to move fast with a limited amount of budget and resources to get your molecule to first-in-human, and then to proof-of-concept (POC). You keep headcount low and outsource wherever you can, often to multiple vendors. Working with multiple vendors means investing significant time to negotiate terms and conditions as well as to oversee the project. Download this case study to learn how one small company took advantage of Patheon’s OneSource™ solution to streamline its drug development and expedite the path of molecule to commercial drug product. ...View More

The Economic Advantage of Single-Source Drug Development and Manufacturing

Tufts Center for the Study of Drug Development (CSDD) recently completed research, titled “Assessing the Economics of Single-Source vs. Multi-Vendor Manufacturing” that compared cycle times and development economics between multi- and single-source CDMO models. While there are many studies that debate the total cost of drug development,1-3 the Tufts study sought a better understanding of which model offered the most accelerated timeto-market for its clients. By focusing on time as a primary value driver, a sponsor can lower the overall cost of bringing its drug to market, and more importantly, achieve the speed-to-market patients both want and need. ...View More

Tightening The Supply Chain: Patheon Aims To Transform Pharma Outsource Manufacturing

Author: Marc Wortman
Pharmaceutical Commerce magazine Nov/Dec issue features an in-depth question and answer piece with Patheon CEO James Mullen. Patheon’s efforts and successes transforming contract manufacturing is profiled in the December issue of leading industry trade magazine, In Vivo. ...View More

The Timely Rise of the CDMO - White Paper

Why revisit your supply chain? The cost of bringing new drugs to market continues to rise. Regulators are demanding more (and more detailed) clinical evidence. Today’s complex molecules – small and large – require an enormous range of technologies that usher in new challenges. ...View More

Streamlining Pharma Drug Development: Yes, It’s Time. - White Paper

The path from molecule to market isn’t getting any easier. A new model for success: focus on what you do best — and outsource the rest. ...View More

A Cure for Pharmaceutical Supply Chain Complexity - White Paper

Author: Lukas Utiger and Mike Mencer
The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. ...View More

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