Axovant Gene Therapies Ltd., a clinical-stage company developing innovative gene therapies, 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.
“This partnership is expected to provide Axovant with sufficient manufacturing capacity to deliver our gene therapies to patients at scale, a key component for the continued development of our gene therapy pipeline,”
said Pavan Cheruvu, chief executive officer of Axovant.
“Partnering with Yposkesi’s global leaders and experts in cGMP-grade vector production strengthens our commitment to building a team with unmatched experience in gene therapy development. With reserved manufacturing capacity and dedicated suite space for Axovant and planned expansions in production capacity, Yposkesi is a preferred manufacturing partner. We look forward to working closely with its team.”
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.
“We are excited to partner with Axovant to support the manufacture and delivery of its innovative gene therapies on a large-scale,”
said Alain Lamproye, chief executive officer of Yposkesi.
“Manufacturing is one of the most critical parts in the development of gene therapies, where expertise and available capacity are key factors. Leaders in gene therapy, such as Axovant, are looking for state-of-the-art facilities, robust manufacturing capacity and years of expertise in producing cGMP-grade material. We strive to deliver industrial experience, innovation and support services to accelerate development of these innovative treatments.”