The initial focus of the agreement will be on AAV-based gene therapies
Axovant Gene Therapies has signed a strategic partnership with a CDMO to mass produce its viral vectors. Yposkesi will provide preferred access and reserved capacity for cGMP grade viral vector production.
This strategic collaboration will provide expertise in process development, technology transfer, manufacturing scale-up, quality control and quality assurance for Axovant. The ongoing prioritised access for manufacturing resources will support the clinical stage company’a gene therapy programmes as they proceed through development and commercialisation. The initial focus of the agreement will be on AAV-based gene therapies.
Pavan Cheruvu, CEO of Axovant, said: “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.”
“With reserved manufacturing capacity and dedicated suite space for Axovant and planned expansions in production capacity, Yposkesi is a preferred manufacturing partner,” Cheruvu added.
CEO of France-based Yposkesi, Alain Lamproye, explained that leaders in gene therapy are looking for state-of-the-art facilities, robust manufacturing capacity and years of expertise in producing cGMP-grade material for outsourcing production. Yposkesi aims to measure up to this, with plans to expand manufacturing for AAV and lentiviral vector production in its current 50,000 sqft state-of-the-art facility. This plant houses multiple independent manufacturing suites.
By 2021, Yposkesi plans to increase this footprint to 100,000 sqft to expand capacity with additional large-scale bioreactors (1,000 L) to further support growing demand for production.
Yposkesi’s current manufacturing processes comply with both European Medicines Agency (EMA) and US Food and Drug Administration (FDA) manufacturing requirements.