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European Biopharmaceutical Review

Balancing Act

Escherichia coli has been the historical workhorse for the production of therapeutic proteins since the first biologic, insulin, hit the market in 1982. It continues to be a preferred system, because operations are inexpensive and timelines are short. Pharmaceutical companies tune the fermentation procedure for the greatest yield in every batch by maximising the cell density per batch and per cell expression. Peak cell density is obtained through process optimisation, and maximal specific productivity is achieved by strain/vector engineering.

These two activities require different research skillsets and are often performed independently of each other. Small virtual companies with preclinical programmes often separate these activities by outsourcing them to different firms. One service provider develops a strain, which is then transferred to a contract manufacturing organisation to maximise the cell density in order to enable the isolation of sufficient product to file an investigational new drug and support Phase 1 and 2 trials.

Such strategies often rely on the assumption that fine-tuning the process can occur during early clinical development. The downfall, however, occurs when fermentation cannot be significantly improved without genetic engineering of the strain. Creation of an entirely new master cell bank constitutes a major procedure change that means going ‘back to the drawing board’. If the end goal is to hand the therapeutic to a large pharma company in order to launch a commercial process, then this downfall can represent a considerable decrease in value.

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April Stanley is the Manager of Cell Line and Strain Development at Cytovance, and earned her Master’s Degree from the University of Illinois, US, in Microbiology. During her six years at Cytovance, she has designed the company’s E. coli toolbox and currently leads the team that developed the platform fermentation processes, which match the production strains generated with the toolbox.
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