Quality by Design risk assessments supporting approved antibody products.
a Genentech , South San Francisco , CA , USA.
Brian
B
Kelley
D000818:Animals; D000911:Antibodies, Monoclonal / Q000235:genetics / Q000276:immunology*; D006801:Humans; D011786:Quality Control; D011994:Recombinant Proteins / Q000276:immunology; D018570:Risk Assessment; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards*
D000911:Antibodies, Monoclonal; D011994:Recombinant Proteins
Control strategy; Quality by Design; critical quality attributes; design space; product licensure; risk assessment