By Eric Langer, president and managing partner, BioPlan Associates, Inc.

Technological advances in genetic engineering, particularly expression systems (the genetically modified cells that express desired proteins), process design, and equipment continue to be combined such that the same amount of drug product can be manufactured at a much smaller scale. Today, smaller-scale, less-expensive equipment is permitting more rapid drug development and production in smaller facilities.

This years 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production continues to show overall increased productivity and efficiency in biomanufacturing. The average expression yield (amount of protein produced in a fixed bioreactor fluid volume), exemplified by mammalian cell culture production of monoclonal antibodies, is now reported to be 2.68 grams/Liter for late-stage clinical supplies manufacturing and 2.29 grams/Liter for commercial-scale manufacturing. These production yields have been increasing since 2008 at an average annual growth rate of 9.8 percent. This almost exclusively involves cell culture using Chinese hamster ovary (CHO) cells. With CHO serving very well and major changes generally avoided in this highly regulated industry, adoption of other and improved expression systems, despite offering further advantages, remains slow.

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Innovation In Expression Systems Yields Increase Productivity

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