FUJIFILM Diosynth Biotechnologies’ UK site receives MHRA Manufacturing License
FUJIFILM Diosynth Biotechnologies has announced that it has received a renewal of its Manufacturer’s Licence from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The Licence authorises 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 utilise single-use technologies, has been designed with input from regulatory authorities, in particular the MHRA, and key customers to offer high flexibility for meeting customers’ needs. It will initially offer 200L and 1000L single-use bioreactors. 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 Licence 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.
Steve Bagshaw, Managing Director of FUJIFILM Diosynth Biotechnologies’ UK site said “We are delighted to have received a renewal of our Manufacturer’s Licence 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.”