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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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Oxford BioTherapeutics Announces Research Collaboration with ImmunoGen to Develop Novel Antibody-Drug Conjugates
OXFORD, UK and SAN JOSE, California, 13/06/2022 - Oxford
BioTherapeutics (OBT), a clinical stage oncology company with a pipeline
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Bio/Pharmaceutical Methods: Do your Analytical Methods Hold Up to Regulatory Scrutiny?
Eurofins BioPharma Product Testing
As FDA guidelines evolve and drug products on the market begin to age, bio/pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are even facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe. This exercise requires significant amounts of time and resources, which many manufacturers do not have since they are focused on getting their next products to market. For that reason, some clients have been turning to Eurofins Lancaster Laboratories for support.
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