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Expanded manufacturing options
October 2019
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CRANBURY, N.J.—Amicus Therapeutics Inc. and Thermo Fisher Scientific have a strategic manufacturing collaboration underway that will boost Amicus’ clinical and commercial manufacturing capabilities for its intrathecal AAV Batten disease gene therapy programs. Under this agreement, current research and development production technologies and capabilities related to Amicus’ gene therapy programs for CLN6, CLN3 and other Batten disease programs will be transferred to and developed at Thermo Fisher Scientific’s viral vector services division.
 
For the CLN6 gene therapy, the existing process for the therapy will be transferred to Thermo Fisher Scientific and undergo a similar GMP process for clinical and commercial-scale manufacturing and supply. The companies will also work together to develop platform manufacturing capabilities to support Amicus’ broader portfolio of AAV gene therapy programs. Financial details were not disclosed.

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