Andelyn to make viral vectors in FNIH led gene therapy consortium

Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC) is managed by the Foundation for the National Institutes of Health (FNIH) and is a public-private partnership between the US Food and Drug Administration (FDA), the National Institutes of Health (NIH), nonprofit organizations, and biopharmaceutical and life science firms with an aim of rapidly developing and delivering adeno-associated vectors (AAV) gene therapies.

BGTC will focus on eight rare disease programs and has selected contract development manufacturing organization (CDMO) Andelyn to advance the AAV manufacturing therapy processes for the treatments of NPHP5 retinal degeneration and CNGB1 Retinitis Pigmentosa 45 using its suspension platform.

“With decades in AAV development and manufacturing, Andelyn leverages its know-how for its AAV suspension platform, a data-driven process that allows for selecting options at each unit operation to achieve the highest, most consistent quality and yields possible, from 125mn flasks to 2,000 L bioreactors and every scale in between,” a spokesperson for Andelyn told us.

“Using a combination of reductionist and holistic approaches Andelyn intentionally builds sysatic optimization methodologies within its suspension production platform for each client program. In addition, established processes from clients can be tech transferred in with the necessary confirmatory work performed to ensure production success.”

Specific ownership of the two candidates “is not public” but the spokesperson said, “Andelyn is partnering with the FNIH to move these two programs forward to clinical trial.”

The CDMO will carry out the work at its Columbus, Ohio facilities. The development will occur at its Andelyn Development Facility (ADC) and production work will take place at the Andelyn Corporate Center (ACC).

No specific timeline has been outlined for this partnership. However, the spokesperson said it is a “long-term partnership and these and future programs each have their own timelines specific to the programs.”