As you advance your biologic drug towards commercial manufacturing and Marketing Authorisation Application (MAA), you need to start process validation activities, and in many cases, you have limited information and data available from the clinical stage. Quality By Design (QBD) has become the gold standard to ensure quality risk management throughout the product life cycle. Statistical Design of Experiment is the method of choice to achieve this goal but finding the right balance between a large number of experiments and speed without sacrificing quality is not always easy. Actually, there are opportunities for more flexible approaches that focus on the critical process parameters and an appropriate process validation strategy.
In this webinar, you will learn:
Director of International Marketing, BioReliance® End-to-End Solutions
Christian Cattaruzza is a microbiology and biochemistry engineer by education (University of Montpellier, France). He joined MilliporeSigma in 1996 and has accumulated 25 years of experience in sales and marketing roles in the life sciences industry. He now leads strategy and marketing for the BioReliance® End-to-End Solutions portfolio of late-stage CDMO services.
Head of Innovation and Industrialization Department, BioReliance® End-to-End Solutions
Corinne Lavie-Cambot is a biotech engineer by education (INSA, Toulouse, France) with 20 years of industrial experience in biotech project management, innovation, process development, GMP production, and process validation.
Head of Process Validation, BioReliance® End-to-End Solutions
David Delvaille is a biotech engineer by education (ENSTBB, Bordeaux). He has specialized in mammalian/microbial process development participating in multiple process validation projects over the last 15 years. His team is in charge of stage I/stage II strategies including scale-down model activities.
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