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Autor:
Melanie Pallansch, Coral Fulton, Arun K. Dhar, Taka Sohka, David Cetlin, Esha Vyas, Luke Pallansch, Daniel Strauss, Aesha Shah
Publikováno v:
Biotechnology Progress. 34:1213-1220
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 stu