What Happened at the 2nd Raw Materials for Cell & Gene Therapy Summit
As the raw materials landscape for cell and gene therapies continues to grow more complex and critical, the 2nd Raw Materials for Cell & Gene Therapy Summit returned to Boston this October with timely regulatory insights, collaborative strategies, and actionable frameworks for CGT manufacturing.
Attendees heard directly from the FDA and USP, gained practical vendor collaboration strategies from industry leaders like Vertex, and explored material qualification frameworks presented by Ultragenyx and others.
Exclusive Regulatory Insights at the 2025 Summit:
Regulatory Insights into the Evaluation of Extractables in Biologic Therapies: FDA Perspectives & Case Studies
Shaping the Future of Ancillary Materials in Cell & Gene Therapy Insights from ISO Standard Development
Understanding Which Guidance to Adhere to & Leveraging FDA-Recognized Standards for Raw Materials in Cell & Gene Therapies
Ensuring Excipient Quality and Compliance Through the EXCiPACT Certification Framework
Strengthening Raw Material Quality and Supply Chain Confidence Through USP Standards
5 Highlights from the 2025 Meeting:
Exclusive Regulatory & Industry Insights
From Powerhouses such as the FDA, USP & ISO:
Insights from CGT veterans, including Rebecca Potts (USP), and Andrew Sarafanov (FDA) on BLA expectations, compliance strategies, and the future of CGT standards
Building a Resilient Supplier Strategy:
Vertex, Gensight, and MedTherapy revealed how to strengthen supplier partnerships through dual sourcing, vendor qualification, and custom material co-development
Reducing Risk with Proven Qualification Tactics:
Metagenomi, Ultragenyx, and Abeona shared how to manage variability, transition RUO to GMP, and qualify new suppliers post-BLA, without compromising quality
Networking with the Leaders Shaping CGT:
Experts from Bristol Myers Squibb, MedTherapy, and SCB were available for collaboration through networking, workshops, and roundtables that sparked real partnerships
Streamline Raw Material Integration:
Genentech and Roche unpacked how to align teams, run comparability tests, and secure supplier docs to onboard materials faster, while staying fully compliant
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2025 Attending Companies Include
This meeting brought together industry experts across the raw materials landscape including professionals from MSAT, Procurement, QA, QC and more, offering a unique opportunity for cross-functional insights, new learnings and networking. Attendees also engaged with key regulatory and standards stakeholders, including representatives from the FDA, standards coordinating bodies, ISO and the U.S. Pharmacopeia.
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