Quality control of protein drugs

Testing of protein drugs must include assays for purity, identity, safety, and potency. The structure of the final product as well as potential impurities are strongly influenced by the type of producing organism (bacteria, yeast, mammalian or insect cells).

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Bibliographic Details
Published inArzneimittel-Forschung Vol. 38; no. 4; p. 590
Main Author Bachmayer, H
Format Journal Article
LanguageEnglish
Published Germany 01.04.1988
Subjects
Cells, Cultured
Fermentation
Molecular Weight
Quality Control
Recombinant Proteins - adverse effects
Recombinant Proteins - pharmacology
Recombinant Proteins - standards
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Summary:Testing of protein drugs must include assays for purity, identity, safety, and potency. The structure of the final product as well as potential impurities are strongly influenced by the type of producing organism (bacteria, yeast, mammalian or insect cells).
ISSN:0004-4172