Minaris Regenerative Medicine, a global manufacturing partner to the cell and gene therapy industry, has undergone the first commercial manufacturing run of LYFGENIA – a one-time gene therapy for the treatment of sickle cell disease developed by bluebird bio – 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.
The first commercial drug product was manufactured in early May. This successful manufacturing attempt confirms the capability of Minaris Regenerative Medicine to produce the gene therapy at a commercial scale.
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 US.”
