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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 Moderator: Mathew Cherian, Consultant - USA Co-moderator: Maria Mantziri, Quality Project Manager, IPS ExCo Associate - Germany Panellist: Krishnan Sampath, Executive Director, Analytical and Drug Product Sciences MacroGenics - USA

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