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.
About Friedreich’s Ataxia
FA is a rare genetic disease caused by abnormally low levels of a protein called frataxin due to mutations in the FXN gene. Deficiency in frataxin leads to mitochondrial malfunction, impaired energy production, and progressive neuromuscular and cardiac damage. AavantiBio’s AAV-based therapy is designed to deliver a functional copy of the FXN gene to cells so that they can produce frataxin. FA affects one in every 40,000-50,000 people and is the most common form of hereditary ataxia in the United States.
About AavantiBio
AavantiBio is a gene therapy company backed by a premier syndicate of life sciences investors including Perceptive Advisors, Bain Capital Life Sciences, and RA Capital Management, who led the company’s recent $107 million Series A financing. Headquartered in Cambridge, Massachusetts, AavantiBio is advancing a diversified gene therapy pipeline in areas of high unmet medical need, including a lead program in Friedreich’s Ataxia (FA), a rare inherited genetic disease that causes cardiac and central nervous system dysfunction. The company benefits from strategic partnerships with the University of Florida’s renowned Powell Gene Therapy Center and the MDA Care Center at UF Health where AavantiBio’s co-founders and renowned gene therapy researchers Barry Byrne, M.D., Ph.D., and Manuela Corti, P.T., Ph.D., maintain their research and clinical practices. Learn more at www.aavantibio.com.
About Catalent Cell & Gene Therapy
Catalent Cell & Gene Therapy is an industry-leading technology, development and manufacturing partner for advanced therapeutics. Its unique and comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-licensed viral vector facility, and fill/finish capabilities located in both the U.S. and Europe.
About Catalent
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 15,000 people including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com