Amicus Therapeutics and Thermo Fisher Scientific have begun a new strategic manufacturing collaboration. Thermo Fisher will provide Amicus with immediate clinical and commercial manufacturing capabilities and capacity for its intrathecal AAV Batten disease gene therapy programmes.
Amicus has also established a plasmid supply network together with multiple long-term supply agreements from industry leading plasmid suppliers to support the advancement of all current gene therapy pipeline programmes in its portfolio.
- Batten disease programmes: Current research and development production technologies and capabilities related to the Amicus preclinical and clinical-stage gene therapy programmes for CLN6, CLN3, and other potential Batten disease programmes are being transferred to and developed at Thermo Fisher’s viral vector services business.
- CLN6 Batten disease gene therapy: The existing process for the CLN6 Batten disease gene therapy is being transferred to Thermo Fisher and undergoing a similar GMP process for clinical and commercial-scale manufacturing and supply.
- Broader portfolio: Thermo Fisher and Amicus will collaborate to develop platform manufacturing capabilities to support the broader portfolio of AAV gene therapy programs
John F Crowley, Chairman and CEO of Amicus, said: “As we advance one of the industry’s leading gene therapy pipelines, our partnership with Brammer Bio, now part of Thermo Fisher, is a significant next step in fulfilling our manufacturing strategy.”
Chris Murphy, VP and General Manager of viral vector services at Thermo Fisher Scientific, said: "We see this as a strong strategic relationship to enable manufacturing of a deep gene therapy pipeline across various stages of development for people with devastating genetic diseases.”