Billingham, Teesside, UK and Research Triangle Park, NC, USA, 19th August 2014 : FUJIFILM Diosynth Biotechnologies has announced continued expansion of its cell culture manufacturing capabilities with the addition of two 2000L single-use bioreactors. One each of these is being installed at the company's sites in Research Triangle Park (RTP), NC, USA 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 1000L single-use bioreactors with 250L to 1,000L operating volumes, with an additional 200L single-use bioreactor in the UK, and a 2000L stainless steel train in RTP, which has been in place for a number of years manufacturing a range of products.
"The addition of these two new bioreactors will meet the demand we are seeing for a 2000L platform, and offer a cost-effective, low-risk route to market through 'scaling-out' from early phase to commercial manufacture" says Mr. Steve Bagshaw, Chief Executive Officer, FUJIFILM Diosynth Biotechnologies. He adds "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' cell culture manufacturing experience with significant single-use facility expansions in the last three years at both sites. The facilities have been inspected by key regulatory authorities and utilise both traditional platforms as well as the latest single-use technologies. The new 2000L bioreactors are expected to be operational by November 2014 in the US and in the UK in January 2015.
Mr. Bagshaw concluded "With these expansions, FUJIFILM Diosynth Biotechnologies is able to deliver a significantly enhanced, full life cycle 'Gene to GMP' service for our customers".