Pfenex’s Reagent Proteins division’s manufacturing partner, Serum Institute of India, began the construction of a new large scale cGMP CRM197 production facility, which is expected to be completed next year. Annual capacity will be in excess of 50 kilograms of cGMP grade CRM197, according to Pfenex.
The additional capacity will enable Reagent Proteins to continue to support conjugate vaccine products currently being developed by its partners, explained Bertrand Liang, Ph.D., CEO of Pfenex. CRM197 is a mutant of diphtheria toxin having a single amino acid substitution of glutamic acid for glycine. It functions as a carrier for polysaccharides and haptens, making them immunogenic. It is utilized as a carrier protein in a number of approved conjugate vaccines for diseases such as meningitis and pneumococcal bacterial infections.
Pfenex CRM197 is a recombinant form expressed in Pseudomonas fluorescens using the Pfenex Expression Technology™ platform. The product currently being manufactured at Serum Institute is also being used by said institute as the carrier protein for its own internal pneumococcal polysaccharide conjugate vaccine programs.
Last October, Pfenex awarded Althea Technologies a contract for the cGMP manufacturing of circumsporozoite protein from Plasmodium falciparum, a component of a vaccine for malaria. Althea Technologies is also relying on the Pfenex Expression Technology-based production process.