" class="no-js "lang="en-US"> LEXEO Therapeutics and FUJIFILM Diosynth Biotechnologies Announce Collaboration to Support Development and Manufacturing of Gene Therapies for Genetic Diseases - Medtech Alert
Sunday, March 03, 2024

LEXEO Therapeutics and FUJIFILM Diosynth Biotechnologies Announce Collaboration to Support Development and Manufacturing of Gene Therapies for Genetic Diseases

LEXEO Therapeutics, a fully integrated clinical-stage gene therapy company advancing adeno-associated virus (AAV)-mediated treatments for genetic conditions, and FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and viral vectors, today announced a strategic collaboration to support the development and manufacturing of LEXEO’s AAV-mediated gene therapies.

FUJIFILM Diosynth Biotechnologies will provide good manufacturing practice (GMP) production, analytical development, process optimization, and chemistry, manufacturing and controls (CMC) for LEXEO’s clinical-stage programs, with an initial focus on the upcoming pivotal study for LX1004, an AAV-mediated gene therapy for potential treatment of CLN2 Batten disease. Production of clinical and commercial supply for LEXEO’s pipeline will utilize single-use suspension bioreactor technology, creating a common manufacturing platform and technology base that will support vector demand across all pipeline programs.

“This partnership provides us with the basis for an integrated supply chain, complementing internal CMC capabilities and will position LEXEO to advance multiple late-stage clinical programs simultaneously,” said R. Nolan Townsend, Chief Executive Officer of LEXEO Therapeutics.

“We’re confident that FUJIFILM Diosynth Biotechnologies’ industry leading technology expertise and experience in gene therapy manufacturing will help position LEXEO for long-term success as we advance programs from early to late clinical studies,” said Paul McCormac, Senior Vice President, Technical Operations of LEXEO Therapeutics.

Gerry Farrell, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies, Texas, added, “This synergistic partnership combines our world-class technical expertise in gene therapy manufacturing with LEXEO’s cutting-edge pipeline to accelerate the development of transformative medicines for patients.”

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