Staying ahead of regulatory trends surrounding particles in the manufacturing of cell and gene therapies

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Tue, Aug 23, 2022 11:00 AM EDT Staying ahead of coming regulatory concerns surrounding particulates in cell and gene therapy manufacturing. Do you know how many particles are in your biomanufacturing process and what to do to reduce them?

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Event Overview:

Particulate contamination is an important consideration in pharmaceutical production, and even more so in cell and gene therapy production and delivery as well as in ophthalmic applications Every source of contamination must be considered in biomanufacturing process, drug formulation as well as drug delivery.. One potential source of contamination is single-use systems (SUS) and components. Learn more about the risks of potential contamination and how to monitor and mitigate. . . Several key aspects of particle contamination control are reviewed in this webinar: Technical and regulatory concerns, Clean manufacturing environment, Continuous testing

Key Learning Objectives:

  • Regulatory expectation on visible and sub-visible particulates
  • How to test for particulate contamination
  • Manufacturing practices to minimize particle contamination
  • Staying ahead of emerging regulations and standards

Who Should Attend:

  • Scientists and engineers working in biomanufacturing, cell therapy, gene therapy, SVP/LVP, ophthalmic production
  • Validation and qualification experts
  • QA experts for single use consumables
  • Single use systems and consumables manufacturer
  • Bio/pharmaceutical professionals considering SUS adoption Event

Mark Bumiller
Technology Manager
Entegris, Inc

Mark is Technology Manager for the AMH instrumentation group (formerly Particle Sizing Systems) at Entegris, Inc. Mark has worked in the field of particle size analysis for over thirty five years. He has served as a member of the expert committee for USP 788, the executive committee of the International Fine Particle Research Institute, and the executive committee of Particle Technology Forum of the American Institute of Chemical Engineers. Mark is an active member of ISO Technical Committee 24, SC4 helping to write standards for particle size and zeta potential analysis.

Joy Xiaohui Chen
Senior Applications Engineer
Entegris, Inc.

Joy Xiaohui Chen is a Senior Application Engineer at Entegris, Life Sciences. She has more than a decade of industrial experience with expertise in developing single-use bioprocessing solutions including bioprocessing bags, membrane filters, and bioreactors for different pharmaceutical applications. She has previously worked at GE Life Sciences (Now Cytiva) and GE Global Research in the areas of physiological monitoring, disease diagnostics & prognostics, cell & gene therapy and precision medicine.

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