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Pfenex Inc., Through Its Reagent Proteins Business Division, Announces Capacity Expansion For cGMP CRM197 Production
By: PR Newswire
Jan. 16, 2013 06:00 AM
SAN DIEGO, Jan. 16, 2013 /PRNewswire/ -- Pfenex Inc.'s Reagent Proteins division announced today that its CRM197 manufacturing partner, Serum Institute of India Ltd., has commenced the construction of a new large scale cGMP CRM197 production facility. This facility, targeted for completion in 2014, will be the largest dedicated CRM197 production facility in the world with annual capacity to produce in excess of 50 kilograms of cGMP grade CRM197. The additional capacity will enable Reagent Proteins to meet the increasing global demand for CRM197 and to continue to support conjugate vaccine products currently being developed by its partners. Serum Institute utilizes Pfenex Expression Technology™ as the production platform, enabling high titers of this high quality conjugate vaccine carrier protein. The Pfenex CRM197 currently being manufactured at Serum Institute is also being used by Serum Institute as the carrier protein for its own internal pneumococcal polysaccharide conjugate vaccine programs. Reagent Proteins offers pre-clinical and cGMP grade CRM197 carrier protein to the vaccine industry enabling novel conjugate vaccine development efforts. In addition, Reagent Proteins provides partners access to a Type 2 Biologics Master File in support of regulatory submissions for their conjugate vaccines. Currently, Pfenex CRM197 is a component in preclinical and clinical stage human vaccine products in development in both North America and Europe. "CRM197 is increasingly being used by the global vaccine development community, and this new facility allows us to not only meet the growing needs of our current partners, but also allows us to support new research and development efforts," said Dr. Bertrand Liang, CEO of Pfenex Inc. "By leveraging our long standing relationship with Serum Institute of India, we are able to further provide our partners with access to high quality vaccine components produced using the powerful Pfenex Expression Technology™, all the way from early stage research through the clinic and into commercialization." For the full press release please visit (http://www.pfenex.com/news/details/30) About Pfenex Inc. SOURCE Pfenex Inc.
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