● 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.

Minaris Regenerative Medicine, a global manufacturing partner to the cell and gene therapy industry, 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, NJ site.

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

Minaris Regenerative Medicine has manufactured cell and gene therapy 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 cell and gene therapy 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 United States.”  

About Minaris Regenerative Medicine

Minaris Regenerative Medicine is a global contract development and manufacturing organization (CDMO) for cell and gene therapies. Our vision is creating future cell therapy miracles together and we are committed to providing global manufacturing services, development solutions, and technologies for cell and gene therapies 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 North America, Europe, and Asia allow us to supply patients worldwide with life-changing therapies. Minaris Regenerative Medicine is wholly owned by Resonac Holdings Corporation.