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Pfenex Inc., Through Its Reagent Proteins Business Division, Announces Submission of Biologics Master File for Recombinant CRM197 to US FDA
Date:5/17/2011

SAN DIEGO, May 17, 2011 /PRNewswire/ -- Pfenex Inc.'s Reagent Proteins division announced today that it has submitted a Biologics Master File (BMF) to the United States Food and Drug Administration for its cGMP grade CRM197 carrier protein to support the development of conjugate vaccine products by its partners.

Reagent Proteins is supplying cGMP grade CRM197 carrier protein to multiple partners in support of their novel conjugate vaccine development efforts.  As part of the product offering partners are granted access to the BMF in support of regulatory submissions for their conjugate vaccines.  The BMF was developed in partnership with Pfenex's cGMP manufacturing partner, Serum Institute of India Ltd.

Serum Institute is a global leader in vaccine development and production whose vaccines have been used in over 140 countries around the world.  It is estimated that two out of every three children immunized in the world is vaccinated by a vaccine manufactured by Serum Institute.  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 program.

"This filing with the US FDA marks another important milestone for our Reagent Proteins business unit," said Dr. Bertrand Liang, CEO of Pfenex Inc, "The ability to provide our partners with access to  high quality vaccine components produced using the powerful Pfenex Expression Technology™ as well as supporting their regulatory agency filings through providing access to Biologics Master Files, demonstrates our unique value proposition.  By leveraging our long standing relationship with Serum Institute of India, we are able to provide our customers with a rapid and scalable path into the clinic and through to commercialization."

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