Fujifilm Diosynth Biotechnologies is adding a 1,000 L Xcellerex® single-use bioreactor to its Research Triangle Park (RTP), NC, facility. This expansion, which includes single-use mixers and single-use harvest filtration, will supplement existing seed train and purification equipment as part of a hybrid implementation approach. The expansion is anticipated to be validated and fully operational by the first quarter of 2012.
Fujifilm Diosynth Biotechnologies says that this project is the continuation of its ongoing cell culture capacity expansion. This addition complements the 200 L Xcellerex single-use bioreactor already in operation at the company’s process development laboratories in Cary, NC, and the existing 2,000 L stainless steel train located in the RTP manufacturing plant.
“Single use technologies are uniquely suited for multiproduct contract manufacturing with the added advantage that the operations are easily transferable between sites and are easily expandable for increased supply needs,” states Stephen Spearman, president of Fujifilm Diosynth Biotechnologies USA.
The XDR-1000 can be operated at working volumes ranging from 200–1,000 L. “The flexibility of scale will allow us to better serve the demands of companies requiring material for preclinical studies, early to mid-phase clinical production, and beyond,” adds John Foy, senior director of business development and logistics at Fujifilm Diosynth RTP.
Besides its sites in North Carolina, Fujifilm Diosynth Biotechnologies has a site in Billingham, U.K. The firm develops and manufactures recombinant proteins, vaccines, and mAbs, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems. The company’s services range from cell line development using its pAVEway™ system to process development, analytical development, and clinical and commercial manufacturing.