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.
"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," 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 2,000L 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 lifecycle ‘Gene to GMP’ service for our customers."