FUJIFILM Diosynth Biotechnologies (Fujifilm), a leading Contract Development and Manufacturing Organization (CDMO) with experience focused on the development and manufacture of recombinant biopharmaceuticals and Advanced Therapies, has announced the opening of its state-of-the art Flexible Manufacturing Facility (FBF) in College Station, Texas.
The 7500 square meters facility utilizes state-of-the-art Mobile Clean Room technology to allow for multiproduct and multi-class production of Advanced Therapies.
“With flexibility at the core of its design, the FBF can produce both clinical and commercial therapeutics; it is ready to make batches today and is capable of rapid expansion to meet the growing demands of the industry,” said Martin Meeson, President and COO of FUJIFILM Diosynth Biotechnologies, USA.
The FBF complements the existing Process and Analytical development and manufacturing capabilities at National Centre for Therapeutic Manufacturing operated by Fujifilm which is equipped for Phase I/II GMP production of Advanced Therapies and is also located in College Station, Texas.
“Developers of gene therapies need reliable and proven partners with the ability to support not only clinical production but to be ready to move swiftly into commercial production,” said Gerry Farrell, Chief Operating Officer of FUJIFILM Diosynth Biotechnologies, Texas site. “For many of the gene therapies in development, Breakthrough Status designation is desired to bring the therapies quickly to patients therefore selecting the right manufacturing partner will be key.”
The gene therapy market has been steadily growing over the past decade and it is expected to continue to grow at a significant pace. Clinical studies have demonstrated the efficacy of gene therapies for many indications. In 2017 alone, three gene therapy treatments were approved in the United States by the FDA and many other candidates are in clinical trials.