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Serum Institute of India builds cGMP facility

17 January 2013 | News | By BioSpectrum Bureau

Serum Institute commences CRM197 production facility

Serum Institute commences CRM197 production facility

Bangalore: Pfenex's reagent proteins division announced that its CRM197 manufacturing partner, Serum Institute of India, 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.

"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.

"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," he added.

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