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Does innovation in biologics CMC really matter?

IBC’s Biopharmaceutical Development and Production Week, usually held somewhere in southern California in March to attract the winter weary from the east coast and mid-west, was, as usual, very worthwhile in spite of the less than perfect weather typically expected in that part of the country. I found the two key notes given by Dr. Jens Vogel of Boehringer Ingelheim and Tina Larson of Genentech particularly enjoyable. Both talks focused on innovation and efficiency in process development and manufacturing.

Dr. Vogel began his talk by asking, “Does innovation in biologics CMC matter in a platform world?” He was referring to the increasing use of platform processes to reduce development time and cost to Proof of Concept (PoC) to develop the five to ten molecules it takes to successfully launch one molecule. Market forecasts show predict no, or limited, growth for branded pharmaceuticals in “developed” markets, i.e., US and Europe, and this is driving the markets towards generics and cost controls. In contrast, emerging markets are driving global pharmaceutical growth. These markets have rising incomes, the population of which can now afford more expensive biopharmaceuticals; however pharmaceutical companies serving these areas may require local manufacturing for access to certain emerging markets. Based on these trends, it’s logical to question the significance of innovation in biologics CMC when global markets require fast and flexible development, fine control of critical quality attributes (CQA), and flexible manufacturing concepts.

While Dr. Vogels’ talk focused on development stage products, Ms. Larson approached the innovation and efficiency question from the commercial manufacturing perspective. She posed the question, “Is there any need for ‘innovation’ in an industrializing sector?” Ironically, even with Genetech’s extensive batch history, batch inconsistency is still a problem for some of their commercial products. Ms. Larson discussed manufacturing technology approaches to address batch inconsistencies which included equipment and facility design such as flows, sanitization and chromatography column packing; automation such as algorithms and manufacturing execution systems (MES); sensors and data technology such as trouble shooting and fault detection and prevention; and raw materials such characterization and specifications and monitoring and control. She went on to describe several examples of manufacturing innovation driven by the maturation of the antibody industry that included overall data management, at-line cell culture analysis, improved purification measurement, at-line endotoxin testing, column packing robustness, cleaning and materials of construction, disposable chromatography equipment, novel drug formats like knob-into-hole bi-specific antibodies and ADCs, facilities of the future and drug delivery.

Both talks gave a thorough overview of the multiple innovations being used throughout the industry for both early phase development and commercial manufacturing. Clearly, CMC innovation 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 have developed and managed processes if not to gain a competitive advantage then surely out of necessity.

 

Blog article by: Patti Seymour