Fujilfilm Diosynth has received no critical or major observations from the UK regulators at its new site in mammalian cell culture facility.
After 15 months, the contract manufacturing organization (CMO) opened the doors to its new facility in Billingham, UK, last week offering biomanufacturing services to customers with 200L and 1000L bioreactors already installed, and a 2000L bioreactor planned for next year.
Today the company announced the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has renewed its manufacturing license to include the new facility, citing zero critical or major observations.
“We are delighted to have received a renewal of our Manufacturer’s Licence from the MHRA,” said Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies’ UK site.
“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.”
The company has already begun working on its first customer project at the new facility.
Speaking with our sister publication, Biopharma-Reporter.com, spokeswoman Bridget Hall said the new facility will also have cell line development capabilities for customers. “The services are aimed mainly at clients starting pre-clinical development and as such we are able to offer two CHO based cell lines.”
The opening of the new site and regulatory license comes six months after the firm opened a cell banking facility - incorporated in the Billingham site - telling us it was looking to access a larger slice of the biologics market.
“The cell banking facility is a small section of the new Mammalian facility it was just completed and operational earlier than the rest of the facility so we could commence business,” Hall said.
“The manufacturing facility contains the cell growth and production suites, including downstream processing and buffer make up and hold areas.”