This one-hour webinar provides an overview of cell therapy product development and manufacturing, based on USP General Chapter <1046> Cellular and Tissue-Based Products, and USP General Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products. Chapters <1046> and <1043> are valuable resources for cell therapy product development and testing strategies. Chapter <1046> addresses issues related to manufacturing, sourcing of materials, and characterization of cell therapy products. Chapter <1043> provides guidance on risk-based qualification of ancillary materials used in manufacturing cell therapy and tissue-engineered products. Together, these chapters provide essential guidance for anyone developing or manufacturing cell therapy products.
After taking this course, you will
- Understand key considerations for development of cell therapy products
- Understand the roles of USP General Chapters <1046> and <1043> as resources supporting cell therapy product development and testing strategies
- Be aware of other relevant USP general chapters for cell therapy
For more information on this specific offering, click here! |
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USP Staff and Approved Instructor:
Scott R. Burger, MD
Former member of USP Expert Committee
Principal, Advanced Cell & Gene Therapy, LLC
Chairman, Scientific Advisory Board, HemaCare Corporation
Fee: US$195.00
For more information on other course offerings–
Email: PharmED@usp.org
Phone: +1-301-230-6304
Website: www.usp.org/meetings-courses/courses
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