21 June 2019 | News
Partnership secures access to reserved cGMP capacity and resources at Yposkesi for manufacturing to support the global development and commercialization of Axovant’s gene therapy programs
Axovant Gene Therapies Ltd., a clinical-stage company developing innovative gene therapies, today announces it has signed a strategic partnership with Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) for preferred access and reserved capacity for cGMP grade viral vector production.
Under this strategic collaboration, Yposkesi will provide expertise in process development, technology transfer, manufacturing scale-up, quality control and quality assurance. The ongoing prioritized access for manufacturing resources will support Axovant’s gene therapy programs as they proceed through development and commercialization, with an initial focus on the AAV-based gene therapies.
Yposkesi is the largest European CDMO for gene therapy with capabilities to expand manufacturing for AAV and lentiviral vector production in its current 50,000 ft2 (approx. 5,000 m2) state-of-the-art facility, which houses multiple independent manufacturing suites. By 2021, Yposkesi plans to increase this footprint to 100,000 ft2 (approx. 10,000m2) to expand capacity with additional large-scale bioreactors (1,000 L) to further support growing demand for production.
As a spin out from Genethon, a pioneer in the discovery and development of gene therapies, Yposkesi has 25 years of experience in GMP development and manufacturing and a team of over 150 scientific, industrial and technical specialists. Yposkesi’s current manufacturing processes comply with both European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) manufacturing requirements.