AavantiBio, Catalent team up on AAV manufacturing for rare genetic diseases

April 28, 2021

Partnership will begin with tackling Friedreich’s ataxia, then extend to other gene transfer therapies

AavantiBio, a gene therapy company, and Catalent, a delivery technology provider, have established a partnership to support the development and manufacturing of AavantiBio’s gene therapies, including its lead program in Friedreich’s ataxia (FA).

Catalent will provide process development and cGMP (current good manufacturing practice) manufacturing of AavantiBio’s adeno-associated viral (AAV) vector-based therapeutic candidate for use in clinical trials in the US and Europe. Catalent will further support process optimization and look to lessen material timelines at its process and clinical development center in Baltimore, MD.

“We look forward to working with Catalent on the development of our differentiated pipeline of innovative gene transfer therapies, focused initially on our FA program,” says Bo Cumbo, president and CEO, AavantiBio. “This partnership highlights the importance of prioritizing chemistry, manufacturing and controls as a foundational element of the company. We believe this approach will position AavantiBio for long-term success as we begin to advance therapies to transform the lives of patients with FA and other rare diseases.”

Catalent has facilities for production of plasmid DNA and cell and gene therapies in Maryland and Texas, along with Gosselies, Belgium. These sites offer development and manufacturing services to support projects from clinical- to commercial-scale, and house multiple cGMP manufacturing suites, comprising of fill-finish, testing labs, warehousing and supply chain services.