The biopharmaceutical contract manufacturing (CMO) industry has experienced a significant improvement in the average expression levels for both mammalian cell culture and microbial fermentation, according to the “Biopharmaceutical Contract Manufacturing 2009: Expanding Markets, New Capacities and Improved Performance” report recently published by HighTech Business Decisions.
The industry study with directors from 29 biopharmaceutical CMOs and 48 pharmaceutical and biotechnology companies showed that expression yield has improved significantly over the last two years. Firms attribute much of the increase to use of high-expression systems and continuous process improvement.
Improvements in efficiency and increased productivity resulting from new technologies have helped CMOs gain new customers. For example, Oxford-Emergent Tuberculosis Consortium, a joint venture between the University of Oxford and Emergent BioSolutions, signed a commercial license agreement in May with ProBioGen to explore production of the MVA85A TB vaccine using ProBioGen’s AGE1.CR.pIX® cell line.
Companies cite improvements in media, overall process, and cell-line development as examples of methods that will further improve yields. However, increased titers and improved expression yields have created pressure on downstream processing. In addition to capacity concerns, the downstream processing bottleneck is consistently cited by pharmaceutical and biotechnology companies as one of the top three biomanufacturing challenges.
Many CMOs are addressing the downstream processing bottleneck by implementing membrane chromatography, high-performance liquid chromatography (HPLC), protein crystallization for protein purification, wider adoption of disposables, and use of process analytical tools (PAT).