Fujifilm Diosynth Biotechnologies is an industry-leading biologics contract manufacturing organization with locations in Research Triangle Park, North Carolina, and Billingham, U.K. The company was formed in April 2011 following the acquisition of the Merck BioManufacturing Network, which consisted of the former Diosynth Biotechnology and Avecia Biologics businesses.
As Fujfilm Diosynth Biotechnologies we have over 25 years’ combined experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, expressed in a wide array of microbial, mammalian, and insect systems.
We serve biopharmaceutical clients of all sizes, worldwide, including virtual, big, and small biotechnology companies and large pharmaceutical companies from around the globe.
Expertise in the development, refinement,and technology transfer of preclinical through commercial cGMP manufacturing processes has been repeatedly demonstrated. Scale-up, validation, and regulatory services support customers in North America, Europe, Canada, Australia, and Japan. Our goal is to increase the value of our customers’ pipeline and products. We help our customers succeed by developing processes efficiently, rapidly, and cost-effectively from preclinical development to market supply.
As a full-service contract manufacturer, we can meet your needs at every stage of the product lifecycle. We offer an extensive breadth of process-development capabilities from cell-line and strain development, using proprietary pAVEway™ and CHO cell line systems, to process development, analytical development, clinical and commercial manufacturing. Both sites are FDA-approved for the production of commercial products.
Our capabilities include, but are not limited to: expertise in producing products from a wide range of cell types including CHO, NS0, SP2/0, hybridoma, E. coli, Pichia pastoris, S. cerevisiae, and Baculovirus; batch, fed-batch and single-use bioreactor production technologies are employed at volumes from 15 L to 5,000 L; production of recombinant proteins/peptides products for therapeutic and vaccine applications from mammalian and microbial expression systems; expert operator of multi-product facilities and a long track record of efficient execution of cGMP manufacturing campaigns.
Most recently we have expanded our manufacturing capacity by adding single-use bioreactor capabilities. We offer our clients the benefits of single-use upstream manufacturing in a proven organization with commercial cGMP compliance standards.
Experience solutions and learn more about how we can assist your development and manufacturing programs, please contact us.