The HHS through the Biomedical Advanced Research and Development Authority (BARDA) has awarded Pfenex a contract for up to $18.8 million provided that certain milestones are achieved and all options and extensions are exercised. The contract will support the development of a Pfenex Expression Technology™-based production strain and process for the manufacture of bulk recombinant protective antigen (rPA) from anthrax.
Pfenex will apply its platform to identify high-producing expression strains capable of producing high titers of stable rPA. It will then leverage its process-development and scale-up capabilities to create a cGMP process at commercial production scales. It is also tasked with evaluating the performance of the protein in IND-enabling studies.
Pfenex’ Expression Technology platform is based on the microorganism Pseudomonas fluorescens for the production of research proteins, reagent proteins, biopharmaceuticals, and biosimilars. It is designed to ensure soluble and active expression through the avoidance of proteolytic clipping and post-translational modifications along, the firm explains. Solubility is further enhanced through protein-folding improvements.
The platform also has a rapid fermentation cycle time that utilizes a low-cost, defined medium with no animal-derived components, says Pfenex. It achieves high specific and volumetric expression titers and can be incorporated into virtually any fermentation scale-up system in use today, the company reports.