- Axovant Gene Therapies said Thursday it has signed a deal with the French contract development and manufacturing organization Yposkesi, reserving manufacturing capacity for its experimental treatments.
- The agreement gives Axovant preferred access and reserved capacity for viral vector production, as well as expertise in process development, technology transfer and quality control, the biopharma said in a statement.
- “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,” Axovant CEO Pavan Cheruvu said in the company’s statement.
With no manufacturing capacity of its own, Axovant is dependent on partnerships as it works to bring its first therapies to market. The company currently has agreements with Oxford BioMedica and Nationwide Children’s Hospital to supply material.
Yposkesi is focused on gene therapy and plans to double its manufacturing capacity for AAV and lentiviral vectors to 100,000 square feet, according to the companies’ statement. It also plans to create additional large-scale bioreactors.
Company CEO Alain Lamproye said Yposkesi will look to help Axovant accelerate development of its treatments. Axovant has three therapies in clinical testing – for Parkinson’s disease, GM1 gangliosidosis and GM2 gangliosidosis.
Manufacturing is one of the biggest challenges facing companies that are coming up with novel gene therapies. The processes are complex and require special facilities with new supply chain demands.
That’s left many companies competing to find specialized CDMOs. About 65% of total spending on gene therapy manufacturing is outsourced, according to Thermo Fisher Scientific’s pharma services head. The growing market factored into Thermo Fisher’s decision this year to buy viral vector manufacturer Brammer Bio for $1.7 billion.
Indeed, the head of the Food and Drug Administration's Center for Biologics Evaluation and Research told BioPharma Dive this month that his top concern for the future of gene therapy is whether manufacturing can be scaled up enough to match scientific advances.
The past few months have featured a raft of announcements about expansions for gene therapy manufacturing, as well as major mergers and acquisitions. In addition to the Thermo Fisher-Brammer deal, Catalent in April said it would buy Paragon Bioservices for $1.2 billion.
“Manufacturing is one of the most critical parts in the development of gene therapies, where expertise and available capacity are key factors,” Yposkesi CEO Lamproye said in Thursday's statement.