Course Description:
About 20 years ago, USP began supporting development and quality assessments of cell, gene and tissue-engineered products by producing a series of general chapters that contained manufacturing and analytical expectations to ensure quality products. General Chapters <1046> Cell-Based Advanced Therapies and Tissue-Based Products, <1047> Gene Therapy Products and <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products were the initial standards developed, and these continue to be revised as new approaches mature. As an extension of the work in <1043>, USP developed several informational and test chapters applicable to raw materials used in manufacturing these therapies. Some of these chapters contain tests that help evaluate the quality of ancillary materials. Physical Reference Standards were also developed to serve as controls and comparators for those procedures.
Due to feedback that development of additional standards could provide tools and greater clarity of quality expectations, USP formed a new BIO5 Expert Committee to support development of standards for advanced therapies. To help inform this work and receive feedback from stakeholders, this webinar will gather experts with advanced therapy product development, manufacturing, regulatory, and standards-setting experience to share their insights and recommendations on tools that can advance these products to patients more efficiently while maintaining high quality. Beyond documentary standards, the panel will also discuss the types of reference materials that are most needed as standards to ensure the quality of cell and gene therapy products.
This “What’s New in Biologics?” webinar is fourth in a series that shares the knowledge and expertise from USP staff and global experts on topics that will shape the future of biologics. This event will be hosted live so that participants can submit questions to the speakers. It will then be available for on-demand viewing.
Who should participate:
- Lab personnel in research and development, manufacturing and production
- Scientists and managers of manufacturing and contract research organizations
- Quality assurance and quality control specialists and auditors
- Regulatory professionals
Speakers
Fouad Atouf
Vice President, Science—Global Biologics
USP; Ph.D., Pierre & Marie Curie University