Catalent wins CDMO contract with Amicus Therapeutics

The US biotech company has chosen Paragon Gene Therapy development and manufacturing capability for lysosomal disorder programmes

Amicus Therapeutics has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics, for clinical manufacturing capabilities and capacity for multiple active preclinical lysosomal disorder programmes that are currently in development in collaboration with the University of Pennsylvania (Penn).

Penn has transferred technology to Paragon in the past and will collaborate with Amicus throughout the process.

“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 programmes," said John F. Crowley, Chairman and Chief Executive Officer of Amicus.

With Paragon’s expertise and platform capabilities we hope to expedite the process of moving our preclinical gene therapy programmes into the clinic as quickly as possible

For Crowley, advancing a robust manufacturing process and supply is critical to Amicus' 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 programmes into the clinic as quickly as possible," he said.

Amicus—who announced a strategic agreement with Thermo Fisher's Brammer Bio as CDMO—has established a plasmid supply network and long-term supply agreements with industry-leading plasmid suppliers to support the advancement of all current gene therapy pipeline programmes.

Highlights of Amicus-Paragon agreement

The collaboration includes:

  • Multiple active preclinical lysosomal disorder programmes: the current research and development production technologies and capabilities related to multiple active preclinical lysosomal disorder programmes are being transferred to and developed at Paragon.
  • Adeno-Associated Virus (AAV) manufacturing platform: establishing an AAV manufacturing platform will further advance and establish manufacturing for multiple Amicus preclinical gene therapy programs while leveraging Paragon’s established manufacturing capabilities for initial clinical supply and commercial product.
  • Pompe preclinical gene therapy program: Initial technology transfer and process development to focus on Amicus Pompe AAV gene therapy program.

“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 centre of excellence for gene therapy, trusted by top biopharmaceutical companies," Buzy concluded.

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