State College-based NeuExcell, a privately held early-stage gene technology company, and FUJIFILM Diosynth Biotechnologies an industry-leading biologics contract development and manufacturing organization, recently signed a manufacturing agreement to rapidly advance NXL-001.
The drug is a potential neuro-regeneration gene therapy to treat ischemic cortical stroke.
Under the agreement FUJIFILM Diosynth Biotechnologies will provide NeuExcell with drug substance and drug-product manufacturing for its first-in-human clinical studies. This will be provided under accelerated timelines and completed at FUJIFILM Diosynth Biotechnologies cGMP mammalian manufacturing facility in College Station, Texas.
“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,” Gerry Farrell, FUJIFILM Diosynth Biotechnologies (FDB) COO for the Texas site, said. “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.”
NeuExcell’s pipeline covers major neurodegenerative diseases.
FUJIFILM Diosynth Biotechnologies has more than 30 years of experience developing and manufacturing recombinant proteins, vaccines, monoclonal antibodies, and other products.