title: Commercial development considerations for biotechnology-derived therapeutics.
abstract: Although it seems unlikely, it has only been 20 years since the US Food and Drug Administration (FDA) approved the first recombinant protein as a therapeutic modality. Unbelievably, an average of slightly more than two approvals per year of monoclonal antibodies (MAbs) and other human protein therapeutics has been achieved by this burgeoning industry 43 recombinant protein therapeutics in the two decades since 1982 (see Table 1), and the pace is increasing.
authors.affiliation: Department of Comparative Medicine, XOMA (US) LLC, Berkeley, CA 94710, USA.
authors.forename: B J
authors.initials: BJ
authors.lastname: Marafino
authors.forename: M K
authors.initials: MK
authors.lastname: Pugsley
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D001709:Biotechnology; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000188:drug therapy*; D017277:Drug Approval; D015195:Drug Design; D004345:Drug Industry; D006801:Humans; D015202:Protein Engineering; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D011994:Recombinant Proteins