Re-processing of biological products: regulatory considerations from the CBER perspective.
Shacter
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Division of Therapeutic Proteins, CBER, FDA, Rockville, Maryland 20852, USA. shacter@cber.fda.gov
D001688:Biological Products; D001709:Biotechnology / Q000379:methods / Q000592:standards*; D033161:Government Regulation; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*
D001688:Biological Products