The non-exclusive collaboration will see Pfenex engineer bacterial strains and develop production processes for SAFC’s customers as part of its contract manufacturing business.
SAFC, the fine chemicals unit of Sigma-Aldrich, will then transfer the processes to its recently expanded current good manufacturing practices (cGMP) quality production facility in Jerusalem, Israel.
In addition, Pfenex will work with SAFC on the production of vaccine components and development of conjugate vaccines through its Reagent Proteins division.
Pfenex spokeswoman Cassidy Brady told Outsourcing-pharma.com that: “The SAFC strategic partnership will focus on identifying customers seeking the total solution, from the design and engineering of a robust production strain, process development and scale up and cGMP production.
“SAFC is offering to subsidize a portion of the upfront costs of strain engineering on behalf of the customer in return for a cGMP manufacturing commitment.
Under the deal Pfenex will receive fees for its strain engineering and process development work as well as licensing fees from SAFC for access to the expression technology.
The SAFC deal is similar to an agreement Pfenex signed with the contract manufacturing wing of Boehringer Ingelheim in February and is further evidence of the platform’s flexibility according Brady.
“Given the rapid adoption of the Pfēnex Expression Technology by large pharma and small biotech companies it behooves CMO’s to add Pfēnex to their portfolio of technologies.”
Pfenex’ approach uses a Pseudomonas fluorescens-based platform technology that, the firm claims, can rapidly produce difficult to express proteins using the concept of parallel processing to expression strain development.
Instead of traditional linear development method, Pfenex’ model allows construction and testing of thousands of unique expression strains combining novel gene expression strategies and host cell phenotypes within five weeks.
This is a distinct advantage according to Cassidy, who claimed the platform has a 90 per cent rate in expressing proteins that have not previously been produced in other systems.
“In addition“ she continued “the high titers of soluble active protein that are routinely achieved… enable CMO’s to more efficiently utilize their manufacturing assets and also avoid the need to maintain equipment for refolding insoluble protein.”