Fujifilm Diosynth Biotechnologies expands culture capacity
Adds 1,000L single-use bioreactor for mammalian and insect cell culture
Fujifilm Diosynth Biotechnologies, which has plants in the US and UK, is expanding its contract manufacturing capabilities with the addition of a 1,000L Xcellerex single-use bioreactor at its RTP, North Carolina, US facility.
The addition of the bioreactor, single-use mixers, and single-use harvest filtration will supplement existing seed train and purification equipment as part of a hybrid implementation approach.
The project continues an on-going cell culture capacity expansion by Fujifilm Diosynth Biotechnologies.
The new bioreactor complements a 200L Xcellerex single-use bioreactor already in operation at the company’s Process Development Laboratories in Cary, NC, and a 2,000L stainless steel train located in the RTP cGMP manufacturing plant.
‘Single-use technologies are uniquely suited to 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 200–1,000L and this flexibility of scale will allow the company to serve the demands of companies requiring material for pre-clinical studies, early to mid-phase clinical production and beyond.
The expansion is anticipated to be validated and fully operational by Q1 in 2012.
Fujifilm Diosynth Biotechnologies was formed in April as a result of Fujifilm Corporation’s acquisition of the Merck BioManufacturing Network. The company comprises the former Diosynth Biotechnology, based in Research Triangle Park, NC, US and MSD Biologics (previously Avecia Biologics) based in Billingham, UK.