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European Biopharmaceutical Review
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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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