Assessing the Criticality of Product Quality Attributes

Recombinant therapeutic proteins contain a variety of chemical and physical modifications, whose impact on safety or efficacy may be unknown. Many of the chemical conversions also occur in vivo, and knowledge of these reactions can be applied to assess the attribute’s impact on the safety, potency and/or clearance of the drug. This talk will describe the development and use of tools designed to investigate attributes’ biological impact, with emphasis on those tools that probe safety. A formal approach to ranking attributes’ impact will also be presented.