At Center for Breakthrough Medicines, our mission is to save lives by accelerating the development and manufacturing of advanced therapies.
Our fully integrated services include drug substance and drug product for all phases of the product lifecycle at a single site.
Multi-Year Deal to Focus on Phase 3 Clinical Trial Supplies and Commercial Manufacturing King of Prussia, PA — September 20th, 2022 —The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the unique requirements associated with commercializing cell and gene therapies, and jCyte, a clinical-stage biotech company focused on preserving and restoring vision in patients with retinitis pigmentosa (RP) and other retinal degenerative diseases, today announced a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte’s U.S. Food & Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell. Under the terms of the agreement, CBM will provide Phase 3 clinical trial supplies and commercial drug product following Biologics License Application (BLA) approval of jCyte’s proprietary jCell platform technology. CBM will also provide all BLA-enabling Chemistry, Manufacturing and Controls (CMC) work to support the program through regulatory approval and commercialization. “jCyte is conducting truly advanced, groundbreaking research into treating patients with RP and other retinal degenerative diseases, and we are honored to partner with them during this critical phase of their clinical trial program as they prepare for BLA submission and commercialization,” said Joerg Ahlgrimm, Chief Executive Officer of Center for Breakthrough Medicines. “We have built world-class technical teams combined with industry-leading product and process development, manufacturing, and testing capabilities, all located within a single manufacturing facility. Our unique and focused approach simplifies and expedites the completion of critical product and process development work and subsequent manufacturing campaigns, thereby shortening the time to market entrySeptember 20, 2022
CBM has appointed of Mandy Conver as Senior Vice President (SVP) of Business Development for Testing & Analytics, and Jennifer Manning as (SVP) of Global Strategic Partnerships.July 27, 2022
The Center for Breakthrough Medicines (CBM) in partnership with the Discovery Labs announced today the acceleration of plans to build capacity to manufacture more than 10,000 patient therapies in direct response to the critical shortage of cell therapy supply, which will help patients win their courageous battles against cancer.June 13, 2022
iECURE, a gene editing company focused on mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of liver disorders with significant unmet need, and Center for Breakthrough Medicines (CBM) today announced the companies have entered into a strategic collaboration wherein CBM will produce and supply Good Manufacturing Practices (GMP)-grade adeno-associated virus (AAV) for use in iECURE’s future clinical studies to enable development of iECURE’s programs with the shared mission of accelerating the availability of these potential treatments to the patients.May 25, 2022
Strategic Partnership to Deliver US Based Manufacturing Capacity for Novel Cell Therapy King of PrussiaApril 12, 2022
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