Fujifilm Diosynth Biotechnologies has bought two 2,000L GE Healthcare bioreactors for its sites in Billingham, UK and North Carolina, US, in response to an order from an undisclosed client and deal with growing market demand, spokesman Mark Douglas told Biopharma-Reporter.com.
While Fujifilm continues to operate stainless steel reactors at the US site, the firm is “seeing a lot of interest in single-use because of the flexibility, quick turnaround and easy scale-up from clinical manufacturing,” he said.
Systems larger than 2,000L are not common according to Douglas, who said he was unaware of any other biomanufacturers looking at single-use systems bigger than this.
“The productivity of mammalian cell lines is on the up, meaning we can make significant quantities of biologics without increasing the bioreactor size past 2,000,” he said. ”This is as big as we’re interested in as if there is a need to increase production we have developed processes in 1,000 and 2,000L which can be replicated.”
Other biologics contract manufacturers including Lonza and Catalent have also invested in single-use technologies, with Catalent telling us in 2012 its 1,000L vessels were “comparable to much larger units” thanks to its expression technology producing up to 5,000 grams of product within the capacity.
However, despite increasing productivity technologies some biopharma companies - including Pfizer, Janssen and Eli Lilly - have said single-use is still a long way from being fully implemented due to its capacity limitations.
Safety and Security
Fujifilm selected the 2,000L bioreactors from GE’s range of single-use systems as a “logical extension” of the Xcellerex platform used across the two sites, though the Billingham site also uses Sartorius Stedim Biotech’s TAP technology.
The systems are “off-the-shelf,” though Douglas said Fujifilm had customised the bag for optimal use.
A further criticism of single-use systems are problems in quality and the threat of leachables and extractables contaminating a batch. However, Douglas told us in Fujifilm’s experience it has never suffered from such issues due to its vigorous quality system tests.
“At Fujifilm, we have a very significant vendor risk assessment. Furthermore, there is an increased level of security involved with the supplier, GE, not releasing bag orders until full integrity and structure-based tests are carried out.”
The new bioreactors are expected to be operational by November 2014 in the US and in the UK in January 2015.