October 1, 2013 (Vol. 33, No. 17)
Fujifilm Diosynth Biotechnologies is an industry leading biologics contract development and manufacturing organization with a strong track record in process development, refinement, and technology transfer of biopharmaceuticals, from preclinical through commercial cGMP manufacturing. With an extensive breadth of process development capabilities, combined with analytical development, clinical and commercial manufacturing, we support our clients at every stage of the product lifecycle. At our sites in Billingham, U.K., and Research Triangle Park, NC, we offer a broad range of mammalian and microbial cGMP manufacturing capabilities. Together we employ over 800 employees and have over 15 years of experience working with over 150 complex proteins. Our sites have received successful regulatory inspections from all key regulatory agencies.
Markets Served
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 pre-clinical development to market supply.
Capabilities
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 our proprietary pAVEway™ and CHO cell line systems, to process development, analytical development, and 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 15L to 5,000L; production of recombinant proteins/peptides products for therapeutic and vaccine applications from mammalian and microbial expression systems; expert operator of multiproduct facilities and long track record of efficient execution of cGMP manufacturing campaigns.
Recently we have increased capacity for mammalian cell culture production at our Research Triangle Park, NC, site and recently opened cGMP mammalian cell culture facility at our Billingham, U.K., site.
Fujifilm Diosynth Biotechnologies
101 J. Morris Commons Lane
Morrisville, NC 27560
Phone: 866.762.6259
Website: www.fujifilmdiosynth.com
Date Founded: 2011 (as Fujifilm Diosynth Biotechnologies) More than 15 years as Diosynth Biotechnology & Avecia Biologics
Number of Employees: > 800
