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Published in 2018 at "Biotechnology Progress"
DOI: 10.1002/btpr.2694
Abstract: Viruses can arise during the manufacture of biopharmaceuticals through contamination or endogenous expression of viral sequences. Regulatory agencies require “viral clearance” validation studies for each biopharmaceutical prior to approval. These studies aim to demonstrate the…
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Keywords:
mvm;
virus mice;
noninfectious surrogate;
virus ... See more keywords