Teesside, United Kingdom (September 14, 2023) – FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organization 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.”
Customers interested touring the facility in person or speaking with an expert should use the Contact Us form.
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization partner for the development and manufacture of biologics, vaccines, cell and gene therapies, and oncolytic viruses. The company operates a global network with major locations in the United States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacture of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary Paveway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. For more information, go to: www.fujifilmdiosynth.com.
About FUJIFILM Holdings Corporation
FUJIFILM Holdings Corporation, Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver Value from Innovation in our products and services in the business segments of healthcare, materials, business innovation, and imaging. Our relentless pursuit of innovation is focused on providing social value and enhancing the lives of people worldwide. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information about Fujifilm’s Sustainable Value Plan 2030, click here. For the year ended March 31, 2023, the company had global revenues of approximately 2.9 trillion yen (21 billion $USD at an exchange rate of 134 yen/dollar). For more information, please visit: www.fujifilmholdings.com.