The FDA approves remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
News|Articles|April 28, 2021
Catalent Enters into Gene Therapy Manufacturing Collaboration with AavantiBio
Author(s)Pharmaceutical Technology Editors
Under the terms of the agreement, Catalent will handle the process development and CGMP manufacturing of AavantiBio’s adeno-associated viral vector-based therapeutic candidate for use in clinical trials in the US and Europe.
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Catalent announced on April 27, 2021 that it has entered into a partnership with AavantiBio, a US-based gene therapy company, to support the development of AavantiBio’s gene therapies, including its lead program in Friedreich’s Ataxia (FA), a genetic disease caused by low levels of the protein frataxin due to mutations in the FXN gene.
Under the terms of the agreement, Catalent will handle the process development and CGMP manufacturing of AavantiBio’s adeno-associated viral vector-based therapeutic candidate for use in clinical trials in the US and Europe, Catalent said in a company press release. Catalent will also provide process optimization while reducing material timelines at its process and clinical development center in Baltimore.
“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 CEO of AavantiBio, in the press release. “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,” added Manja Boerman, PhD, president, Catalent Cell & Gene Therapy, in the press release. “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.”
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