title: Quality by design for biopharmaceuticals.
authors.affiliation: Process Development, M/S 30-2-A, One Amgen Center Drive, Thousand Oaks, California 91320, USA. asrathore@yahoo.com
authors.forename: Anurag S
authors.initials: AS
authors.lastname: Rathore
authors.forename: Helen
authors.initials: H
authors.lastname: Winkle
mesh_terms: D001688:Biological Products / Q000138:chemical synthesis / Q000494:pharmacology*; D001702:Biopharmaceutics; D001709:Biotechnology / Q000379:methods / Q000639:trends; D002626:Chemistry, Pharmaceutical / Q000379:methods; D015195:Drug Design; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products