AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, and Catalent, a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, have announced 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 manufacturing of AavantiBio’s adeno-associated viral (AAV) vector-based therapeutic candidate for use in clinical trials in the U.S. and Europe. Catalent will further support process optimization and look to reduce material timelines at its process and clinical development center in Baltimore, Maryland.
“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,” said Bo Cumbo, President and Chief Executive Officer of 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 is committed to partnering early with innovative companies and facilitating the development and optimization of robust, scalable manufacturing solutions," commented Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. “Our development team at the University of Maryland BioPark is focused on providing process optimization services to meet our customers’ needs and partnering with them to bring
innovative therapies to patients faster.”
Catalent has facilities for the production of plasmid DNA and cell and gene therapies in Maryland and Texas, U.S., and in Gosselies, Belgium. These sites provide development and manufacturing services to support projects from clinical- to commercial-scale, and house multiple CGMP manufacturing suites, including fill/finish, testing laboratories, warehousing, supply chain capabilities, and other associated services.
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