Yposkesi, a leading CDMO for gene therapy viral vector manufacturing, today announces an agreement in principle governing the terms of a strategic partnership with Axovant Sciences, a company developing innovative gene therapies for neurologic and neuromuscular diseases.
Upon execution of the definitive agreement, the partnership would grant Axovant reserved capacity for cGMP-grade Adeno-Associated Virus (AAV) production. It will provide dedicated suite space with ongoing prioritized access to manufacturing resources for Axovant’s AAV-based gene therapy programs through development and commercialization.
Yposkesi brings to the partnership extensive gene therapy manufacturing capabilities for AAV and lentiviral vector production. This includes its current 50,000 ft2 (approx. 5,000 m2) state-of-the-art facility, housing multiple independent manufacturing suites for bulk drug substance and fill and finish, and the company’s’ expertise in vector development and manufacturing. As a spin-off of the gene therapy pioneer Genethon, Yposkesi benefits from Genethon’s 25 years of experience in the field. Axovant will have access to Yposkesi’s manufacturing processes, complying with both European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) manufacturing requirements for phase I-III clinical trials. By 2019 Yposkesi will extend its capacity to further support commercial production, and by 2021 will increase its global footprint to 100,000 ft2 (approx. 10,000m2).
In addition to the dedicated cGMP production capacity, the long-term, strategic collaboration between Yposkesi and Axovant would provide dedicated expertise in process development, technology transfer, manufacturing scale up, quality control and assurance.
“We are very pleased to partner with Axovant to support the manufacture and delivery of its innovative gene therapies on a large scale,” said Alain Lamproye, CEO of Yposkesi. “Leaders in gene therapy, such as Axovant, are drawn to our state-of-the-art facilities, robust manufacturing capacity and years of expertise in producing cGMP-grade material. We look forward to contributing to advancing Axovant’s innovative and robust gene therapy pipeline.”
Yposkesi is a leading Contract Development & Manufacturing Organization (CDMO) for gene therapy vector manufacturing. Created in November 2016 in Corbeil-Essonnes (France) as a spin off from the world-class gene therapy pioneer Genethon, Yposkesi provides integrated services; covering bioprocess development (USP & DSP), from small/pilot to large scale production, analytical development, GMP manufacturing of clinical batches of lentiviral and AAV vectors and regulatory support. Its current facility consists of a 50,000 ft2 (approx. 5,000 m2) building, operating multiple manufacturing suites for bulk drug substance and fill & finish. By 2019 Yposkesi will extend its capacity to further support commercial production. By 2021 it will increase its global footprint to 100,000 ft2 (approx. 10,000m2) with a second large-scale facility designed for commercial production and EMA and FDA compliance. Capitalizing on the more than 25 years’ expertise of Genethon, Yposkesi invests significantly in innovation in bioprocessing to deliver on high quality projects, cost-effectively.