Analytical Strategies for Comparability in Bioprocess Development

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.
Presented by Dr Christine P. Chan, Ph.D. of Sanofi
Dr. Christine P. Chan is currently Principal Scientist in Global Manufacturing Science & Technology, Specialty Care Operations at Sanofi. She is a protein biochemist with broad experience in the biopharmaceutical industry, including prior experience at Sandoz Pharmaceuticals and Merck & Co., Inc. She specializes in the analysis of recombinant products produced from mammalian cells for vaccines and biologics development. Her application experience includes expression cell line selection, drug substance & drug product process development, manufacturing tech transfers and lifecycle management of commercialized products.
 
 
Sponsored by Unchained Labs

 
 
 
 
 
 
Here’s the deal. We’re all about helping biologics researchers break free from tools that just don’t cut it. Unleashing problem-tackling products that make a huge difference in the real science they do every day. That’s our mantra, our promise and we own it.
Presented by Joe Barco, Ph.D. of Unchained Labs


Joe Barco is the Director of Product Marketing at Unchained Labs. He is responsible for new product launches and product development for protein analytical tools.
Joe received his PhD in Chemistry from Stanford University. He has spent 15 years in the biotechnology instrumentation arena, first as an applications scientist, followed by positions of increasing responsibility in product management and marketing. His main interest is bringing better tools to scientific discovery.
 
 
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.