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FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.
FUJIFILM Diosynth Biotechnologies has completed its new facility in Darlington, United Kingdom, which is now operational and can carry out current good manufacturing practice (CGMP) manufacturing of viral vector-based gene therapies, oncolytic viruses, and viral vaccines for clinical trials. The completion of this facility is part of the company’s investment strategy to address the increased demand for production of early stage clinical trial (first-in-human) investigational viral vector products, the company stated in a Sept. 14, 2023 press release.
The new CGMP site houses dedicated high containment clean rooms for viral vector manufacturing and segregated viral and non-viral suites. The facility holds a cell culture capacity of up to 200 L. The addition of the Darlington facility adds to the company’s global locations, which include College Station, Texas, and Watertown, Mass., in the United States (1).
“We are excited to continue working with our biopharmaceutical partners, including early-stage companies, to help them bring new gene therapies to market, which hold tremendous promise in revolutionizing treatment options for patients,” said Jonathan Haigh, head of UK site at FUJIFILM Diosynth Biotechnologies, in the press release. “Our advanced therapy integrated network, including an ongoing commercial viral gene therapy expansion in nearby Billingham, UK, allows customers to benefit from our end-to-end cell and gene therapy services provided by our highly skilled workforce.”
“In addition to providing increased manufacturing capacity for our early stage customers, we look forward to helping them efficiently navigate preclinical and Phase I hurdles by offering complementary services for fast, yet flexible drug candidate screening as well as feasibility studies,” Haigh added in the release. “This additional support will help biopharmaceutical customers create a simple, modular path to cGMP manufacturing, minimizing risk and streamlining drug substance and drug product manufacture for the clinic.”
1. FUJIFILM Diosynth Biotechnologies, Globally Integrated CGMP Production. fujifilmdiosynth.com, accessed Sept. 21, 2023.