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Our team will examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and suggest practical, total solutions.
Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.
In this webinar, we will examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. We will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc.
We will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.
Meet the authors from the ‘Insights on Successful Gene Therapy Manufacturing and Commercialization’ ebook