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It is no exaggeration to say that the world changed in the early 80s when insulin was expressed synthetically in microorganisms for the first time. This breakthrough led to a recombinant (biosynthetic) and thereby safer therapy for diabetes than the animal-sourced insulin which had been used since 1922.
In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. Full compliance to both monographs and general notices and chapters is recommended. Is recombinant insulin a factor to consider for viral production? Free Whitepaper. By Novo Nordisk Pharmatech.
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