What are the best practices for cell and gene therapy CMC? Check out A-Cell and A-Gene, publications developed with NIIMBL on integrating QbD principles into cell-based and gene-based therapy CMC programs. 🧫 A-Cell: alliancerm.org/manufacturing/… 🧬 A-Gene: alliancerm.org/manufacturing/…

Another #genetherapy regulatory decision date was scheduled in the United States. This week, REGENXBIO announced the FDA accepted its Biologics License Application with Priority Review for its gene therapy to treat MPS II, also known as Hunter Syndrome. regenxbio.gcs-web.com/news-releases/…

We’re proud to welcome Rita Johnson-Greene, Chief Operating Officer, Alliance for Regenerative Medicine (ARM), to moderate our keynote panel at Advanced Therapies USA 2025. Don't miss the opportunity to hear from her this November in Philadelphia👉terrapinn.com/adtusa25/regis…

This week, Europe moved closer to its first cell therapy approval of 2025. Autolus announced the EMA CHMP delivered a positive opinion for its CAR-T #celltherapy to treat patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. autolus.gcs-web.com/news-releases/…

Are you an ARM member heading to Boston for BIO 2025 in June? ARM, Catalent, and MilliporeSigma invite you to a private ARM Member reception on Monday, June 16. The reception is open to ARM members only, and an RSVP is required. Learn more here: alliancerm.org/arm-event/bior…