title: Current and future issues in the manufacturing and development of monoclonal antibodies.
abstract: Despite a slow beginning, monoclonal antibodies have had many successes over the past decade. It is important that these successes continue, bringing more products for more indications to market. Although manufacturing is not the most common cause of product failure, product quality issues can delay antibody development. Manufacturing has depended on the triad of process validation, process control and product testing. Applying product knowledge proactively to manufacturing (quality by design) may allow greater flexibility and maintain or improve product quality. An integrated approach to biological characterization is an important aspect of product knowledge. Greater product knowledge also facilitates development in other disciplines. Independent of manufacturing strategy, there are a number of regulatory hurdles in initial and ongoing antibody development. These are described to help prevent unnecessary delays.
authors.affiliation: Office of Biotechnology Products, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA. steven.kozlowski@fda.hhs.gov
authors.forename: Steven
authors.initials: S
authors.lastname: Kozlowski
authors.forename: Patrick
authors.initials: P
authors.lastname: Swann
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000494:pharmacology; D004339:Drug Compounding; D015195:Drug Design; D004345:Drug Industry / Q000639:trends*; D006801:Humans; D011786:Quality Control
chemical_list: D000911:Antibodies, Monoclonal