title: Accelerated formulation development of monoclonal antibodies (mAbs) and mAb-based modalities: review of methods and tools.
abstract: More therapeutic monoclonal antibodies and antibody-based modalities are in development today than ever before, and a faster and more accurate drug discovery process will ensure that the number of candidates coming to the biopharmaceutical pipeline will increase in the future. The process of drug product development and, specifically, formulation development is a critical bottleneck on the way from candidate selection to fully commercialized medicines. This article reviews the latest advances in methods of formulation screening, which allow not only the high-throughput selection of the most suitable formulation but also the prediction of stability properties under manufacturing and long-term storage conditions. We describe how the combination of automation technologies and high-throughput assays creates the opportunity to streamline the formulation development process starting from early preformulation screening through to commercial formulation development. The application of quality by design (QbD) concepts and modern statistical tools are also shown here to be very effective in accelerated formulation development of both typical antibodies and complex modalities derived from them.
authors.affiliation: Drug Product Development, Amgen Inc., Seattle, WA, USA razinkov@amgen.com.
authors.forename: Vladimir I
authors.initials: VI
authors.lastname: Razinkov
authors.affiliation: Drug Product Development, Amgen Inc., Seattle, WA, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Treuheit
authors.affiliation: Drug Product Development, Amgen Inc., Seattle, WA, USA.
authors.forename: Gerald W
authors.initials: GW
authors.lastname: Becker
mesh_terms: D000911:Antibodies, Monoclonal / Q000276:immunology*; D001331:Automation; D002626:Chemistry, Pharmaceutical; D057166:High-Throughput Screening Assays
chemical_list: D000911:Antibodies, Monoclonal
keywords: design of experiment; drug development; formulation development; high-throughput methods; monoclonal antibodies; quality by design