Fujifilm Diosynth Biotechnologies is expanding its existing contract manufacturing capabilities with the addition of a 1,000l Xcellerex® single-use bioreactor to its RTP, North Carolina facility. This expansion reinforces the commitment to lead the global biologics CMO industry through continuous innovation and implementation of new technologies, service delivery and quality, as announced by Japan-based parent company, FUJIFILM Corporation.
The addition of the 1,000l single-use bioreactor and mixers with single-use harvest filtration will supplement existing seed train and purification equipment as part of a hybrid implementation approach. This project is the continuation of an on-going cell culture capacity expansion by Fujifilm Diosynth Biotechnologies. This addition complements the 200l Xcellerex single-use bioreactor already in operation at the company’s process development laboratories in Cary, NC, and the existing 2,000l stainless-steel train located in the RTP, NC cGMP manufacturing plant.
“Single-use technologies are uniquely suited for multi-product contract manufacturing with the added advantage that the operations are easily transferable between sites and are easily expandable for increased supply needs,” said Stephen Spearman, president of Fujifilm Diosynth Biotechnologies USA.
The XDR-1000 can be operated at working volumes ranging from 200l-1,000l. “The flexibility of scale will allow us to better serve the demands of companies requiring material for pre-clinical studies, early to mid-phase clinical production and beyond,” added John Foy, senior director of business development and logistics at Fujifilm Diosynth RTP.
The expansion is anticipated to be validated and fully operational by Q1/2012.