Amicus, Catalent Biologics Enter Gene Therapy Mfg. Pact

Amicus Therapeutics, Inc. has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for clinical manufacturing for multiple active preclinical lysosomal disorder programs that are currently in development in collaboration with the University of Pennsylvania. Penn has transferred technology to Paragon and will collaborate with Amicus throughout the process. Amicus has also established a plasmid supply network and long-term supply agreements with plasmid suppliers to support all current gene therapy programs.

The current research and development production technologies and capabilities related to multiple active preclinical lysosomal disorder programs are being transferred to and developed at Paragon. The collaboration aims to establish an Adeno-Associated Virus (AAV) manufacturing platform to further advance multiple Amicus preclinical gene therapy programs leveraging Paragon’s manufacturing capabilities for initial clinical supply and commercial product. Initial technology transfer and process development will focus on Amicus Pompe AAV gene therapy program.
 
John F. Crowley, chairman and chief executive officer of Amicus said, "As we continue to articulate our near- and long-term Amicus gene therapy manufacturing strategy, our collaboration with Paragon Bioservices is a significant next step in securing clinical scale-up and supply for our Pompe gene therapy, as well as our other active preclinical programs. Advancing a robust manufacturing process and supply is critical to our success. Leveraging our internal expertise and process development in combination with Paragon’s expertise and platform capabilities we hope to expedite the process of moving our preclinical gene therapy programs into the clinic as quickly as possible."
 
"Amicus has a strong gene therapy pipeline focused on addressing many life-threatening conditions where there are urgent needs for treatments and cures," said Pete Buzy, President of Paragon Gene Therapy. "Paragon has a proven track record to develop and successfully manufacture complex biotherapeutics using commercially-scalable processes. This agreement with Amicus highlights our world-class manufacturing team and our track record as a center of excellence for gene therapy, trusted by top biopharmaceutical companies." 

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