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FUJIFILM Diosynth Biotechnologies, NeuExcell Enter Gene Therapy Mfg. Pact

Aims to rapidly advance NXL-001, a potential neuro-regeneration gene therapy to treat ischemic cortical stroke.

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By: Kristin Brooks

Managing Editor, Contract Pharma

FUJIFILM Diosynth Biotechnologies and NeuExcell Therapeutics have entered a manufacturing agreement to advance NXL-001, a potential neuro-regeneration gene therapy to treat ischemic cortical stroke
 
FUJIFILM Diosynth Biotechnologies (FDB) will provide essential drug substance and drug product manufacturing, under accelerated timelines, for NeuExcell’s first-in-human clinical studies.
 
Drug substance manufacturing will take place at FDB’s state-of-the-art cGMP mammalian manufacturing facility in College Station, TX.
 
“The signing of the manufacturing agreement with NeuExcell showcases our flexibility in supporting biotech companies of all sizes, and our focused commitment to enabling NeuExcell to reach the full potential of their innovative gene technology platform on accelerated timelines,” said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas site. “We are proud and delighted to have been selected by NeuExcell as the manufacturing partner for their NXL-001 candidate. It is an honor for FDB to play a role helping to bring a treatment to patients around the world who suffer from ischemic cortical stroke.”
 
“As we prepare to advance NXL-001 into clinical studies, we are pleased to have FUJIFILM Diosynth Biotechnologies, an industry-leading Biologics CDMO, as our trusted partner,” remarked Jie Xu, Co-Founder and Head of Discovery, NeuExcell.  “Securing reliable biomanufacturing is essential and we are grateful to be able to advance the NXL-001 program immediately in FUJIFILM Diosynth Biotechnologies’ state-of-the-art manufacturing facility.”

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