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First Commercial Cell and Gene Therapy Product Manufactured at Minaris Regenerative Medicine in Allendale, New Jersey, US

May 8, 2024 – BioManufacturing, Biotechnology – Minaris Regenerative Medicine, biomanufacturing, cell and gene therapies

With the recent FDA approval of LYFGENIA, developed by bluebird bio, Minaris Regenerative Medicine North America is now supporting a commercial cell and gene therapy (CGT) product
The first commercial drug product was manufactured in early May. This confirms the capability of Minaris Regenerative Medicine as a commercial manufacturing CDMO.

8 May 2024 — New Jersey, US — Minaris Regenerative Medicine, a global manufacturing partner to the cell and gene therapy (CGT) industry, today announced that the first commercial manufacturing run of LYFGENIA – a one-time gene therapy for the treatment of sickle cell disease developed by bluebird bio – was performed at its Allendale, New Jersey, US, site.

The Allendale facility passed Food and Drug Administration (FDA) pre-Licensing inspections, underscoring the necessary capabilities and expertise to successfully manufacture CGTs for commercial use.

Minaris Regenerative Medicine has manufactured CGT products for more than 20 years, supporting its partners from development stage to commercial phase.

Dr Hiroto Bando, CEO, Minaris Regenerative Medicine, commented: “The commencement of commercial manufacturing for LYFGENIA represents an important step for the CGT industry as it will allow many patients fighting sickle cell disease to benefit from this new, potentially curative medicine. Now, I am pleased to announce that Minaris Regenerative Medicine has commercial manufacturing experience in all three of our regions, Japan, Germany and now the US.”

About Minaris Regenerative Medicine

Minaris Regenerative Medicine is a global contract development and manufacturing organisation (CDMO) for CGTs. Our vision is creating future cell therapy miracles together and we are committed to providing global manufacturing services, development solutions and technologies for CGTs to improve society’s well-being. We offer our clients high value clinical and commercial manufacturing services, development solutions and technologies. We are pioneers in the field with more than 25 years’ experience providing outstanding quality and reliability. Our facilities in the US, Europe and Asia allow us to supply patients worldwide with life-changing therapies. Minaris Regenerative Medicine is wholly owned by Resonac Holdings Corporation. Visit: www.rm.minaris.com/en.