MORRISVILLE, N.C. & BILLINGHAM, United Kingdom--(BUSINESS WIRE)-- 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, single-use mixers, and 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 200- 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.
About Fujifilm Diosynth Biotechnologies
Fujifilm Diosynth Biotechnologies (www.fujifilmdiosynth.com) is an industry-leading Biologics Contract Manufacturing Organization with locations in Research Triangle Park, North Carolina, USA and Billingham, United Kingdom. Fujifilm Diosynth has over twenty-five years of combined experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect cell line systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ system to process development, analytical development, clinical and commercial manufacturing. Both sites are FDA-approved for the production of commercial products.
Jennifer Kohm, 919-337-4248
Bridget Hall, +44 1642 367320
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