Fujifilm Diosynth Biotechnologies partner for the development and manufacture of biologics, vaccines, cell and gene therapies, and oncolytic viruses, today announced the successful completion of a new facility in Darlington, UK, which is now cGMP operational for manufacturing of viral gene therapies, oncolytic viruses and viral vaccines for clinical trials. This milestone underscores the company’s investment in and commitment to meeting the increased demand for production of early-stage clinical trial (first-in-human) investigational viral vector products.
“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. “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.”
The cGMP site in Darlington features dedicated state-of-the-art high containment clean rooms for viral vector manufacturing, cell culture capacity up to 200 L, and segregated viral and non-viral suites.
“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,” said Haigh. “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.”