Use of Pfenex Expression Technology in production of bulk recombinant protective antigen (rPA) from anthrax could allow the US to respond more quickly and effectively to a terrorist threat.
Pfenex has won an $18.8m (€14.2m) contract from the US Biomedical Advanced Research and Development Authority’s (BARDA) to work towards this goal. This process is now underway with Pfenex currently designing genes which will ultimately be screened using its platform.
Patrick Lucy, vice president of business development at Pfenex, told in-PharmaTechnologist that screening will identify strains that can express high titres of soluble, active and stable protective antigens.
In proof-of-concept studies Pfenex has achieved titres in the range of several grams per litre. Using a fermentation cycle of 36 hours Lucy said Pfenex could “produce an unprecedented number of vaccine doses in a very short period of time”.
Lucy said: “Pfenex Expression Technology-based process can deliver more doses annually than the current or future capacity projections made by currently available anthrax vaccine products and processes while maintaining a lower overall cost per dose.”
The initial part of the contract is focused on strain engineering and screening, fermentation and downstream processing, and initial purification and stability/immunogenicity testing. This stage will last approximately 16 months and generate a fixed fee of around $10m, plus costs for Pfenex.
Successful completion of this first period could lead to expanded immunogenicity studies, process development and scale up, and stability and potency testing. If all these options are taken the contract could span five years and generate $18.8m for Pfenex.
Eight months on
In December 2009 Pfenex closed Series A financing to become an independent company based on technology from Dow. Formation of the independent company is part of Dow’s efforts to grow firms with significant equity value from its novel technologies.
“Pfenex has had a very successful eight months”, said Lucy. This includes a deal, which generated $52m in upfront and milestone fees, to give Merck & Co access to the Pfenex platform for production of a vaccine.
A number of other deals with domestic and overseas large pharma have also been secured. Pfenex has also developed and partnered two biosimilars, most recently through a deal with Ranbaxy. More biosimilars are in development.
Furthermore, Pfenex has launched a reagent protein business. This produces and sells difficult to express proteins for use in vaccines, cell culture, diagnostics and downstream processing.