Throughout the life cycle of a biotherapeutic it is often necessary to make changes to the manufacturing process and control system. These changes may improve the consistency of the process, increase the scale or yield to meet supply needs, involve improvements to analytical methods, transfer to a new facility or equipment, and/or be designed to improve product quality. When these changes occur it is necessary to demonstrate that product quality is not adversely impacted, and that the safety and efficacy established with prior process versions will be maintained with material from the post-change process. This plenary session will focus on state of the art, science-based and regulatory strategies that enable process changes to be executed successfully and efficiently. In scope topics may include comprehensive comparability strategies guided by patient-centric considerations, lean technical transfers enabled by the use of platform technologies, and perspectives on the use of regulatory tools to support changes.

Session Speakers:

Building a Comparability Strategy for a Major Post-Approval Manufacturing Change

Nathan McKnight, Genentech, a Member of the Roche Group

An Industry Perspective on the Use of Forced Degradation Studies to Assess Comparability of Biopharmaceuticals

Kasia Nowinski, Pfizer, Inc.

Accelerating Biopharmaceutical Development: Data-Driven Strategies, Platforms, and Technologies

Nitin Rathore, Amgen Inc.

Additional Panelist:

Leslie Rivera Rosado, CDER, FDA

Sabina Sheikh

Appearances