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What's in Store for the 2nd Raw Materials for Cell & Gene Therapy Summit?
As the raw materials landscape for cell and gene therapies becomes increasingly complex and pivotal, the 2nd Raw Materials for Cell & Gene Therapy Summit returns to Boston this October with new regulatory insights from the FDA, vendor collaboration strategies from companies such as Vertex, and material qualification frameworks with Ultragenyx and more.
This industry-leading event bridges gaps in GMP standards, comparability testing, and supply chain resilience, equipping attendees to accelerate BLA approvals and mitigate risk. With expanded workshops, FDA and USP participation, and real-world case studies, this year’s Summit is a must-attend for anyone navigating the critical first components of scalable, compliant CGT manufacturing.
5 Reasons Not to Miss Out:
Tap into Exclusive Regulatory & Industry Insights from Powerhouses such as the FDA, USP & ISO:
Hear directly from CGT veterans, including Rebecca Potts (USP), and Andrew Sarafanov (FDA) on BLA expectations, compliance strategies, and the future of CGT standards
Build a Resilient Supplier Strategy:
Vertex, Gensight, and MedTherapy reveal how to strengthen supplier partnerships through dual sourcing, vendor qualification, and custom material co-development
Reduce Risk with Proven Qualification Tactics:
Metagenomi, Ultragenyx, and Abeona share how to manage variability, transition RUO to GMP, and qualify new suppliers post-BLA, without compromising quality
Connect with the Leaders Shaping CGT:
Collaborate with experts from Bristol Myers Squibb, MedTherapy, and SCB through networking, workshops, and roundtables that spark real partnerships
Streamline Raw Material Integration:
Genentech and Roche unpack how to align teams, run comparability tests, and secure supplier docs to onboard materials faster, while staying fully compliant
Who Will You Meet?
This meeting brings 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 will also engage with key regulatory and standards stakeholders, including representatives from the FDA, standards coordinating bodies, ISO and the U.S. Pharmacopeia.