title: Development of specifications for biotechnology products--perspective from Europe.
authors.affiliation: Agence du Médicament, Unité Biologie, Saint-Denis, France.
authors.forename: J H
authors.initials: JH
authors.lastname: Trouvin
mesh_terms: D001702:Biopharmaceutics / Q000592:standards*; D001709:Biotechnology / Q000592:standards*; D017277:Drug Approval; D004340:Drug Contamination; D004341:Drug Evaluation / Q000592:standards; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D005060:Europe; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D011786:Quality Control; D011994:Recombinant Proteins / Q000592:standards; D012449:Safety
chemical_list: D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins