As part of a project to stockpile vaccines in case of anthrax attacks funded by the US Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), Paragon will use Pfenex’s Expression Technology to manufacture all cGMP material from its facility in Baltimore, Maryland.
“We believe Paragon Bioservices will enable Pfenex and BARDA to reach its goal to develop an anthrax vaccine,” Pfenex Sr. Marketing Manager Cassidy Brady told Biopharma-Reporter.com.
“Paragon Bioservices demonstrated successful history utilising our Pseudomonas fluorescens strains to manufacture cGMP material,” she said, and “we believe we can rapidly implement large scale cGMP manufacturing to enable our Phase 1 clinical trial.”
Pfenex Expression Technology
Pfenex originally won a contract with BARDA in 2010 worth $18.8m (€14.2m) using its Expression Platform to initially design genes and screen them to identify strains that can express high titres of soluble, active and stable protective antigens.
At the time, VP of Business Development told our sister publication in-Pharmatechnologist.com the platform enabled production of “an unprecedented number of vaccine doses in a very short time” with a fermentation cycle of 36 hours.
Brady added that Pfenex’s “anthrax vaccine has a very efficient and cost effective production process providing an advantaged cost of goods.”
She continued: “The mutant rPA vaccine has demonstrated higher immune responses than the currently available anthrax vaccine in pre-clinical animal studies and therefore has the potential of providing longer protective immunity with fewer doses.”
Furthermore, “the selected formulation has been shown to be amenable to freeze-drying which could allow for storage at ambient temperatures and provide longer stability.”
BARDA
For BARDA, the use of the platform and this move into clinical manufacture comes as part of an eight year investment in potential anthrax antitoxin candidates at a cost of almost $1bn.
In September BARDA shelled out $196m to replenish stock of GlaxoSmithKline’s monoclonal antibody Raxibacumab, the first drug to be approved for inhalational anthrax, and a further $63m to Canadian firm Cangene to purchase 10,000 treatment courses of Anthrax Immune Globulin (AIG) in the form of plasma.