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Melanie Sena is community editor of Pharmaceutical Technology.
Fujifilm Diosynth Biotechnologies has renewed its manufacturing license from the UK's MHRA.
Fujifilm Diosynth Biotechnologies has renewed its manufacturing license from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The license authorizes commercial manufacturing at the company’s Billingham, UK site, and was received with zero critical or major observations.
The inspection included the company’s new cGMP mammalian cell culture manufacturing facility, which is on schedule for imminent commissioning. This facility, which will primarily utilize single-use technologies, has been designed with input from regulatory authorities, in particular the MHRA. It will initially offer 200 L and 1000 L single-use bioreactors, with 2000 L bioreactors already planned for 2014. The company announced that the cGMP Cell Banking Facility, which forms part of the larger plant, was fully commissioned in April 2013, and has already processed its first cell banks.
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 manufacture of two commercial products in these facilities.