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Can You Afford Not to Embrace Innovation?

IBC’s Biopharmaceutical Development and Production Week, usually held somewhere in southern California in late March to attract the winter weary from the east coast and mid-west, was, as usual, a very informative event. There were several presentations/sessions that focused on innovation in bioprocessing. My colleague, Tom Ransohoff, discusses the innovations for continuous processing in an earlier blog. I found a few sessions on innovation particularly interesting. Dana Anderson of Genentech and Uwe Gottscwack of Lonza set the conference on the right track with their keynote presentations on Monday. Dr. Gottscwack discussed the dominant trends in biomanufacturing for the past few years, which include best practices in mammalian cell culture based manufacturing facility fit trends. He highlighted the trend that new facilities are smaller, modular, standardized and decentralized, and are employing lean manufacturing principles, and disposable and continuous processing technologies wherever possible.

Dr. Anderson discussed the challenges in developing Breakthrough Therapy Products. Once a product is granted Breakthrough designation by the FDA, Chemistry, Manufacturing and Control (CMC) activities often become critical path to filing the Biologics License Application (BLA). Dr. Anderson recommended focusing only on those process optimizations needed to launch, including launching with provisional specifications with an expectation to revise those specifications post-launch as part of the post-approval life-cycle management (PALM) plan. This may allow pivotal clinical studies to be performed with material from different scales and different manufacturing sites with the appropriate bridging comparability performed. Additional suggestions to streamline development were to fix pain points early in development and apply standard, i.e., platform, approaches to all development work where possible. It is expected that shelf life will be an issue for Breakthrough products, especially for global supply chains, because of the inability to compress real-time stability studies.

Kristen Manchester, a scientist in the Manufacturing Sciences and Technology group at Bristol-Myers Squibb (BMS) gave a terrific talk on BMS’s CMC experience with Breakthrough Therapy Designation. She stressed the importance of getting the Quality Target Product Profile (QTPP) defined ASAP so the team is laser-focused on activities needed to support the BLA. She corroborated that the CMC timeline must be compressed, which made BMS proceed in parallel for many activities normally done in series. As a necessity, they made significant improvements in efficiency and communication, and increased project resources and level of outsourcing to achieve these compressed timelines. They maximized efficiency by creating standard flow diagrams and nomenclature, and increased communication using standardized batch tables, which improved consistency throughout documentation.

Many talks gave a thorough overview of the multiple innovations being applied throughout the industry for both early phase development and commercial manufacturing. Clearly, CMC innovation and efficiency is still vitally important for the development and commercial maintenance of biopharmaceuticals. I expect the CMC sector of the industry will continue to transform how we traditionally develop and manage processes if not to gain a competitive advantage then surely out of necessity.

 

Blog article by: Patti Seymour