Through the agreement, Yposkesi, a contract development and manufacturing organization (CDMO) specializing in viral vector manufacturing, will provide Axovant Sciences access to current good manufacturing processes (cGMP) grade facilities for Adeno-Associated Virus (AAV) production.
Axovant will receive dedicated suite space and access to manufacturing resources for its AAV-based gene therapy programs through development and commercialization.
Alain Lamproye, CEO of Yposkesi, told us “flexible and quick access to manufacturing capacity is key in the development of early stage clinical candidates, and especially for viral vectors where a global shortage of capacity has been observed.”
Lamproye said the gene therapy manufacturing market is “booming,” and will continue to grow at rates ranging from 15-20%.
“The recent clinical successes in the treatment of neuromuscular diseases, as well as the advent of CAR-T cells, are all indicators triggering demand for large-scale manufacturing capacities,” he explained.
Additionally, the two companies will work together to establish practices in process development, technology transfer, manufacturing scale-up, quality control and assurance.
Yposkesi will expand its capacity in 2019 to support commercial production following this agreement. The company said it will increase its global footprint by 2021 through a 100,000 square-foot facility equipped with several 1,000L bioreactors.
The manufacturing processes provided through this partnership comply with both European Medicines Agency (EMA) guidelines as well as US Food and Drug Administration (FDA) requirements for Phase I-III clinical trial supplies.