Product characterization can be challenging throughout drug development because it requires advanced technologies and specialized expertise. Thus, it is vital to start product characterization early and use it throughout all phases of the drug manufacturing process. It is also essential to capture a biologic’s activity profile from binding, affinity, and potency bioassays to have a better understanding of a drug’s critical quality attributes.
Choosing a partner to support your product characterization needs can streamline your drug development program and create efficiencies in moving from concept to clinic. Danny Galbraith, PhD, head of product characterization and new services for MilliporeSigma’s BioReliance® services, answers key questions.