Dedicated facility injects CRM197 into conjugate vaccine market

21-Jan-2013 - Last updated on 21-Jan-2013 at 16:01 GMT

New plant to focus on CRM197 production

Reagent Proteins says its ability to produce scalable amounts of protein CRM197 supports the current demand in production of conjugate vaccines.

The comments come following an announcement by Reagent Proteins - a division of Pfenix – that its manufacturing partner, Serum Institute of India, has begun construction on a new facility dedicated to the production of CRM197.

CRM197 is a non-toxic mutant of diphtheria toxin which enhances immunogenicity when coupled with bacterial polysaccharides in conjugate vaccines. The protein is used as a carrier in Prevnar, Pfizer’s pneumococcal disease vaccine.

Pfenex spokeswoman Cassidy Brady set the investment in the context of current market capacity, telling in-Pharmatechnmologist.com that: “Until recently, access to high quality and scalable CRM197 was extremely limited, therefore we are seeing a drastic increase in demand for the carrier protein.”

Brady explained that CRM197 has only been readily available since 2011 when Pfenex Expression Technology was able to produce the recombinant carrier protein in affordable and scalable quantities.

Pfenex Expression Technology and CRM197 growth

Reagent uses The Pfenex Expression Technology as a host platform in producing CRM197 protein. The technology uses a bio-safety level 1 strain of P. fluorescens bacteria as a host to attain higher levels of proteins than the native host in existing technologies and with a lower level of containment.

According to Brady, CRM197 has been shown to be equivalent to the native host. She said that the technology can produce “titers of active, high quality and soluble CRM197 in excess of 10 times that achieved with the native expression host.”

Indian plant to feed CRM197 desire

The platform is currently used at Serum’s facilities in Pune, India and is one of the driving forces in the expansion of its production capabilities. The plant will be able to produce excess of 50 kg of cGMP grade CRM197 annually that will cater for Serum’s own internal vaccine programme as well as supply Reagent’s growing client demand.

Brady said: “This expansion was not only to support our current partners, but to also support the conjugate vaccine development community as a whole by providing access to CRM197 from early stage research through commercialization.”