Miltenyi Biotec To Commercially Supply CliniMACS® Platform To Autolus Therapeutics For Its Manufacture Of FDA-Approved AUCATZYL® (Obecabtagene Autoleucel – Obe-Cel)

Miltenyi Biotec, a global leader innovating technologies and services for patient-specific cell and gene therapies, today announced that it will supply Miltenyi Biotec’s CliniMACS Prodigy® instruments, reagents, and disposables for the manufacture of Autolus’ FDA-approved AUCATZYL® (obecabtagene autoleucel), as part of its longstanding partnership with the CAR T cell therapy developer since 2018.

Bergisch Gladbach – With the recent announcement of the U.S. Food & Drug Administration (FDA) approval, Miltenyi Biotec, a global leader innovating technologies and services for patient-specific cell and gene therapies, will provide a reliable long-term supply of the CliniMACS® family to support AUCATZYL® (obecabtagene autoleucel). Autolus Therapeutics’ (Autolus) programmed T cell product AUCATZYL is a cell-based treatment for adults with relapsed or refractory acute lymphoblastic leukemia, a severe form of leukemia characterized by the overproduction of B lymphocytes in the bone marrow and blood.

Under the commercial supply agreement with Autolus in place since 2018, Miltenyi Biotec will provide high-quality and reliable supply across the full range of its T Cell Transduction (TCT) platform covering products from its Cell Separation, Cell Culture and Stimulation, and Reagents business.

This milestone marks the culmination of a decade-long partnership that leverages Miltenyi Biotec’s scientific, regulatory, and manufacturing expertise, playing a key role in Autolus’ path from pre-clinical development to commercialization for AUCATZYL. During this strategic collaboration, Miltenyi Biotec has contributed its ballroom concept, advanced technologies, and expertise as a foundational blueprint that has been instrumental in enabling Autolus to establish its state-of-the-art cell manufacturing facilities. Complementing this, Miltenyi Biotec has also provided ongoing supply and support of its proprietary CliniMACS Prodigy instruments, reagents, and disposables essential for the manufacture of Autolus’ programmed T cell therapies.

“Miltenyi Biotec’s extensive expertise, along with its seamless support and product quality have been invaluable in our path from innovation to FDA approval with AUCATZYL. We look forward to continuing this longstanding relationship as our business evolves,” said Christian Itin, Chief Executive Officer of Autolus.

“Miltenyi Biotec is dedicated to innovating with cell therapy developers to accelerate access for the patients who need it most. Over the years, our shared commitment with Autolus to advancing life-changing therapies has created a partnership built on trust and mutual growth. As we look to the future, we are confident that our collaboration will continue to make a difference to the way we treat cancer and autoimmune diseases,” said Stefan Miltenyi, Chief Executive Officer and Founder of Miltenyi Biotec.

Through targeted research and development initiatives, spanning process development across discovery, pre-clinical, and clinical phases, developing automated, large-scale manufacturing processes on the CliniMACS Prodigy Platform, as well as establishing an end-to-end manufacturing system, Miltenyi Biotec is collaborating with Autolus to strengthen its pipeline with robust and scalable production capabilities.

About Miltenyi Biotec

Miltenyi Biotec is a global leader innovating technologies and services for patient-specific cell and gene therapies, turning scientific discoveries into practical treatments for personalized medicine. Having pioneered a groundbreaking method of cell separation, Miltenyi Biotec continues to set industry standards today. With over 35 years of expertise, it supports customers in biomedical discoveries, translating them into clinical applications to enable access to new therapies for patients. Miltenyi Biotec focuses on providing integrated, advanced solutions to address complex challenges in the treatment of cancers, autoimmune diseases, and inherited disorders. Through its Miltenyi Bioindustry division, it provides expert guidance to therapy developers, helping them efficiently and cost-effectively navigate the path from process development to commercialization. Miltenyi Biotec is headquartered in Bergisch Gladbach and has a global team of 4,900 employees across 24 countries.

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