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QbD in Biologics Drug Product Development and Manufacturing
Biopharmaceutical drug product development is a multistage process that involves various activities from molecule design to process engineering and validation. QbD based approaches can help connect consecutive stages of product development to each other and ultimately to the desired clinical performance. The webinar will address practical approaches to utilizing QbD based approaches for biologics drug product formulation and process development as well as manufacturing using case studies as examples.

Learning objectives:
*How QbD is applied to discrete stages in biologics development and manufacturing
*Application of QbD that is phase- appropriate
*Case studies of real- life examples

Mathew Cherian, Consultant - USA
Maria Mantziri, Quality Project Manager, IPS ExCo Associate - Germany

Krishnan Sampath, Executive Director, Analytical and Drug Product Sciences MacroGenics - USA
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Dr. Krishnan Sampath
Executive Director @Analytical and Drug Product Sciences MacroGenics USA
Krishnan Sampath is currently an Executive Director and Head of Analytical and Drug Product Sciences at Macrogenics, Inc. He has 18+ years of biotechnology industry experience leading biologics formulation, drug product process development & manufacturing, combination product development and analytical method development and product characterization. Prior to joining Macrogenics in 2015, he was Senior Director at Hospira, a Pfizer company for 4 years overseeing areas of drug product development and bioanalytical sciences for biosimilar programs. Before that, Krishnan was at Amgen Inc for more than 9 years where he worked as a principal scientist on protein formulation, biophysical characterization and analytical methods. He obtained his Ph.D from the University of Colorado in the area of Pharmaceutical Sciences. He has published over 25 journal articles and book chapters, several patents, presented and organized global conference sessions and is currently serving on the editorial
Mathew Cherian
Mathew Cherian @ExCo Member, Industrial Pharmacy Section
Mathew Cherian is a 34-year veteran in sterile product development. His expertise includes biologicals, and sterile dispersed dosage forms like liposomes and emulsions. Currently, he is working as a consultant in pharmaceutical industry.
Maria Mantziri
Quality Project Manager @IPS ExCo Associate