title: Definition of a well-characterized biotechnology product.
authors.affiliation: CBER, FDA, Rockville, MD 20852, USA.
authors.forename: K
authors.initials: K
authors.lastname: Zoon
authors.forename: R
authors.initials: R
authors.lastname: Garnick
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000302:isolation & purification; D001688:Biological Products / Q000737:chemistry* / Q000302:isolation & purification / Q000592:standards; D001709:Biotechnology; D006801:Humans; D011994:Recombinant Proteins / Q000737:chemistry / Q000302:isolation & purification / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D011994:Recombinant Proteins