Streamline Supply Chain Communications to Optimize Phase Appropriate QC Testing, Comparability & GMP Manufacturing of Raw Materials & Achieve Regulatory Compliance of Scalable Cell & Gene Therapies
The 2nd Raw Materials for Cell & Gene Therapy Summit successfully brought together leading voices in the industry to shape the future of cell and gene therapy manufacturing. Attendees gained exclusive insights from regulatory and standards leaders, including the FDA and USP, who shared the latest perspectives on BLA review expectations, raw material characterization, and the evolving global standards landscape.
As the industry continues to navigate growing complexity and supply chain uncertainty, innovators from Vertex, Genentech, and Bristol Myers Squibb showcased how they're transforming supplier strategies through dual sourcing, co-development, and rigorous vendor qualification.
Experts from Ultragenyx, Abeona Therapeutics, and Metagenomi delivered real-world solutions to qualification challenges and variability risks, offering practical guidance that attendees can apply immediately. Hands-on workshops, strategic roundtables, and high-impact networking helped equip participants with the frameworks and partnerships needed to strengthen quality programs and stay ahead of regulatory expectations.
The summit proved to be a vital forum for aligning strategies, adapting to change, and advancing the future of the field.
This summit presented challenges and experiences shared by all industry leaders.
Previous Attendee, Raw Materials for Cell & Gene Therapy Summit
This event is truly the first of its kind, bringing together therapeutic developers and raw material suppliers to harmonize about what the field needs to ensure safe, effective, and streamlined development of CGT products.
Previous Attendee, Raw Materials for Cell & Gene Therapy Summit
The meeting was very informative about where raw materials programs stand now and the expectation for the future.
Previous Speaker, Raw Materials for Cell & Gene Therapy Summit
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