Andelyn Biosciences Selected as Viral Vector Manufacturing Partner for FNIH

  • Andelyn Biosciences has been selected as the viral vector manufacturing partner for the Foundation for the National Institutes of Health (FNIH).
  • This partnership is part of the Accelerating Medicines Partnership® (AMP®) Bespoke Gene Therapy Consortium (BGTC).

Andelyn Biosciences, a cell and gene therapy contract development research organisation, has been chosen as the viral vector manufacturing partner for the Foundation for the National Institutes of Health (FNIH) in the United States. This collaboration is a part of the Accelerating Medicines Partnership® (AMP®) Bespoke Gene Therapy Consortium (BGTC).

The BGTC, managed by the Foundation for the National Institutes of Health, is focusing on eight rare disease programmes. Andelyn Biosciences has been chosen to enhance and scale up AAV therapy processes for treating CNGB1 Retinitis Pigmentosa 45 and NPHP5 retinal degeneration. The AMP BGTC is a public-private partnership involving the NIH, FDA, biopharmaceutical and life science companies, and other organisations. Their goal is to accelerate the development and delivery of AAV gene therapies to help millions of people affected by rare diseases.

Matt Niloff, Chief Commercial Officer of Andelyn, commented, “As a long-standing pioneer in AAV gene therapies with a focus on patients, we have great synergies with the BGTC. Andelyn is privileged to work with the FNIH/BGTC on its first AMP which was established specifically to help overcome the major obstacles related to developing gene therapies for rare diseases.”

“We are pleased to have Andelyn Biosciences as a manufacturing partner for two programs in the BGTC’s clinical portfolio,” said Courtney Silverthorn, Associate Vice President for Science Partnerships at the FNIH and Director of the AMP program. “This is an important step toward reaching our ultimate goal of getting gene therapies to rare disease patients in need sooner, and with fewer hurdles along the way.”

Andelyn Biosciences is a cell and gene therapy development and contract manufacturing organization born out of Nationwide Children’s Hospital, where the first FDA-approved systemic gene therapy was discovered.

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