An FDA perspective of manufacturing changes for products in human use.
Durfor
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Hematologic Products Branch, Food and Drug Administration, Bethesda, Maryland 20892.
Scribner
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D000911:Antibodies, Monoclonal / Q000096:biosynthesis*; D001709:Biotechnology / Q000379:methods / Q000592:standards*; D046508:Culture Techniques / Q000379:methods / Q000592:standards*; D016207:Cytokines / Q000096:biosynthesis / Q000592:standards*; D006801:Humans; D008962:Models, Theoretical; D011994:Recombinant Proteins / Q000096:biosynthesis / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration; D014614:Vaccines, Synthetic / Q000096:biosynthesis*
D000911:Antibodies, Monoclonal; D016207:Cytokines; D011994:Recombinant Proteins; D014614:Vaccines, Synthetic