Analytical Strategies for Comparability in Bioprocess Development

Presented by

Christine P. Chan, Ph.D & Joe Barco, Ph.D.

About this talk

Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration. Sponsored by Unchained Labs Presentation Title: Limber up your lab with better tools for comparing biologics There’s no magic bullet when it comes to characterizing a protein by structure or function. Specific tests may work for one molecule but not the next. Instrumentation that provides a high degree of flexibility, balanced with low sample consumption and faster time to result, is crucial to keep up with ever changing laboratory needs. Unchained Labs puts biologics characterization front and center for our instrumentation development. We will discuss how our instruments let researchers be more flexible and efficient, while also providing clear data to help make comparability assessments.

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