FUJIFILM Diosynth Biotechnologies has announced the continued expansion of its cell culture manufacturing capabilities with the addition of two 2,000l single-use bioreactors. One of each of these is being installed at the company’s sites in Research Triangle Park (RTP), NC, US and Billingham, UK.
The new reactors will complement the range of vessels at both sites, adding further flexibility for customer requirements. Each site currently operates 1,000l single-use bioreactors with 250l to 1,000l operating volumes, with an additional 200l single-use bioreactor in the UK, and a 2,000l stainless-steel train in RTP, which has been in place for a number of years, manufacturing a range of products.
FUJIFILM Diosynth Biotechnologies CEO Steve Bagshaw said: "The addition of these two new bioreactors will meet the demand we are seeing for a 2,000l platform, and offer a cost-effective, low-risk route to market through ‘scaling-out’ from early phase to commercial manufacture."
"Being similar to our existing bioreactors means they will fit seamlessly into our facilities. Having identical single-use operations on both sides of the Atlantic offers our customers flexibility and easy access to global markets. Combined with the expertise of our process development scientists to produce high-titer cell lines, our focus on single-use bioreactor technology for cell culture processes is world class."
The company has over 15 years of cell culture manufacturing experience, with significant single-use facility expansions in the last three years at both sites. The facilities, which have been inspected by key regulatory authorities, utilise both traditional platforms as well as the latest single-use technologies. The new 2,000l bioreactors are expected to be operational by November in the US and by January 2015 in the UK.
Mr Bagshaw added: "With these expansions, FUJIFILM Diosynth Biotechnologies is able to deliver a significantly enhanced, full lifecycle ‘Gene to GMP’ service for our customers."