title: The art of antibody process development.
abstract: Biopharmaceutical drug development is an intricate path that spans a dozen years from discovery through registration. The development of a therapeutic antibody presents substantial challenges, particularly with respect to the creation and implementation of manufacturing process technologies. Process development and large scale biotherapeutic manufacturing is an art generally only practiced within industry. As a consequence, these technologies may be seen as something of a 'black box' by many in the medical community. This article provides insight into the current art of antibody process development leading to market entry of novel, life-saving medicines.
authors.affiliation: Global Biologics, Pfizer Global Research & Development, Chesterfield, MO, USA. david.e.steinmeyer@pfizer.com
authors.forename: David E
authors.initials: DE
authors.lastname: Steinmeyer
authors.forename: Ellen L
authors.initials: EL
authors.lastname: McCormick
mesh_terms: D000911:Antibodies, Monoclonal / Q000096:biosynthesis / Q000737:chemistry / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001702:Biopharmaceutics; D015195:Drug Design; D004345:Drug Industry; D006801:Humans; D018973:Intellectual Property; D033183:Interdisciplinary Communication
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C520704:tremelimumab