What You Need To Know About Process Characterization And Validation For Biologic Processes

By Frank Ritacco, Director, Scientific and Technical Affairs, Thermo Fisher Scientific and Daniel Baskind, Manager, Scientific and Technical Affairs, Thermo Fisher Scientific

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.¹ 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.² 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. These include 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.

However, the recent paradigm shift in the industry toward next-generation therapeutics has resulted in increasingly complex manufacturing processes that are no longer “plug and play.”^{3, 4, 5} The lack of familiarity with these new non-mAb molecules has led to increased attention to their specific risks. Now, a more comprehensive understanding of how to design processes is required to ensure a molecule is developed with the appropriate quality attributes and safety profile. It is therefore imperative to carefully and skillfully evaluate the structural liabilities, key product quality attributes, and process risks associated with your molecule. Insufficient evaluation and understanding of these risks may result in a late-stage strategy that does not lay out a successful path to market.