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What You Need to Know About Process Characterization and Validation For Biologic Processes

A major factor in the growth of the biopharmaceutical industry over the last 20 years has been continuous innovation with monoclonal antibodies (mAbs), which now make up more than 50 percent of the overall biotherapeutic market. A significant driver for success with these therapeutic modalities has been the ability to use templated process and analytical platforms in process development and manufacturing in order to reduce timelines and facilitate robust scale-up. The ubiquity of mAbs has resulted in a strong body of knowledge across the industry that can be leveraged to support critical risk-mitigation activities during the life cycle of biopharmaceutical drug management. This article focuses on the vital steps of process characterization and validation required for commercialization of your biologic molecule, where process control strategies are developed and implemented to minimize risk and control quality.

Whitepaper: What You Need to Know About Process Characterization for Biologic Processes

Telltale Signs You’re with the Wrong CDMO

Late-stage drug development efforts have many moving parts as projects push toward commercialization. During this critical time, companies often take a good long look at their vendors and evaluate their options for scale up to commercial launch. Is your CDMO an asset or a hindrance in this process? How can you recognize whether your partners really contribute everything they can to your end goal of commercialization?

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.

Biologics Fact Sheet

The challenges, risks and costs of bringing complex large molecule products to market are growing exponentially. Gaining a competitive advantage is more difficult. Drawing on 20 years of biologic experience, Thermo Fisher Scientific offers you flexible, end-to-end solutions and expertise in development and manufacturing combined with advanced technical capabilities.

Pharma Services Overview Brochure

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. Drug substances and drug products. Development and manufacturing. Small and large molecules. Sterile, oral solid and softgel dosage forms. Patheon offers a comprehensive range of services spanning all phases and scales that is wider and deeper than any other CDMO. Gain instant access to a fully integrated global facilities network.

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. 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.

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

“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.

Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing

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. As a result, inaccurate demand forecasts can have significant implications for companies developing biologics. And with less industry-wide available capacity for biologic production, it is increasingly difficult to locate capacity to respond to demand changes and ensure products achieve commercial goals.

Biologics & Flexible Biomanufacturing Overview Brochure

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 of schedule while maintaining the highest quality. We bring deep scientific expertise to every challenge and our proven track record of scaling up biologics help ensure you gain cost and time savings at every stage of the biologic development process.

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. 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.

Managing Demand Uncertainty in Biologics Production

When a biologics company prepares to launch a new product, it must forecast the manufacturing capacity it will need. To create this forecast, it must factor in its estimate of the size of future sales, the timing of the launch, the dosage of the product, its strategy for building its market and a host of other variables. Variations in any one of those factors can lead to drastically different demand scenarios. If a company overestimates demand, it may end up investing in too much capacity, and therefore find itself paying more per unit of the product than it needs to, thus impacting its margins. If it underestimates demand, it risks not being able to satisfy demand, therefore losing revenue. 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.

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. This analysis provides further insight and perspective on the key themes that emerge from the report and offers additional solutions to companies to better prepare for the inevitable forecast inaccuracies for biopharmaceuticals.

Consultants’ Guide to Flexible Biomanufacturing Solutions

Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients. Counseling clients on such solutions—especially those that may help to de-risk the increasingly challenging biopharmaceutical development process—can be a win-win for the industry and consumers alike. What follows is a guide to some key strategies that consultants can keep in mind for their smaller biopharmaceutical clients.

Top Five Risks Facing Your Small Biopharma Clients Today

Drug development is an expensive proposition. Discovery and preclinical work are estimated to cost $318 million per compound, with an additional $800 million to $1.1 billion required to advance a molecule from first-in-human testing to market approval. For small biopharmaceutical innovators, steep development costs are compounded by the fact that large molecules are becoming increasingly complex and serious clinical or manufacturing problems may not surface until late in the process. Building upon this risk, events such as mergers, acquisitions, restructurings, political uncertainty and even public criticism can all have a huge effect on a small company’s stock and monetary resources. With a limited amount of money at their disposal for generating clinical data, biopharma firms are often waiting for the perfect moment to pull the trigger and move products quickly through development. This creates a situation where highly compressed process development timelines lead companies to overlook critical factors that could delay— or even suspend—efforts down the road. In this whitepaper, we identify some important risks that consultants should put on the radars of their small biopharma clients. Doing so, along with choosing the right outsourcing partner, will ensure their risks—not their financial returns—are diminished.

Challenges, Risks, and Strategies for Biologic Substance Manufacturing

ORC International’s 2016 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. Download and read Patheon’s perspective to the ORC study “Challenges, Risks and Strategies for Biologic Substance Manufacturing” and discover how biologics companies are increasingly demanding modular and disposable technologies and continuous manufacturing because of the need for flexible capacity.

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.

Multiplexing: Managing Risk with Proven, Single-Use Solutions

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. At that point, it is difficult for developers to forecast demand. Therefore, deciding how much manufacturing capacity they will need is problematic, to say the least. Underestimating or overestimating demand can have a devastating impact on the bottom line.