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).
Bachmayer
H
H
Sandoz Research Institute, Vienna, Austria.
D002478:Cells, Cultured; D005285:Fermentation; D008970:Molecular Weight; D011786:Quality Control; D011994:Recombinant Proteins / Q000009:adverse effects / Q000494:pharmacology / Q000592:standards*
D011994:Recombinant Proteins