Fujifilm Diosynth Biotechnologies has received a renewal of its Manufacturer’s License from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The license authorizes commercial manufacturing at the company’s Billingham, UK site.
The inspection included the new cGMP mammalian cell culture manufacturing facility, which will primarily employ single-use technologies. It will initially offer 200L and 1000L single-use bioreactors, with 2000L bioreactors planned for 2014. The license also covers commercial manufacturing of microbial-based biologics in the company’s large scale manufacturing assets. The company currently has FDA-approval for the manufacture of two commercial products at these facilities.
Steve Bagshaw, managing director of Fujifilm Diosynth Biotechnologies’ UK site, said, “We are delighted to have received a renewal of our Manufacturer’s License from the MHRA. Our customers can be assured that this demonstrates our commitment to quality and ultimately patient care, and confirms our position as a top player in the CMO field for both microbial and mammalian biopharmaceuticals.”