The world's largest drug company, Pfizer, is to make use of a gene expression system developed at Dowpharma for the production of one of its therapeutic proteins.
Dowpharma , a business unit of Dow Chemical, will work with Pfizer to develop a cell line using its Pseudomonas fluorescens-based Pfenex technology, which drives up the yields in biotherapeutics production compared to existing systems such as Escherichia col.
Under the terms of the latest agreement, Pfizer will fund efforts at Dowpharma to evaluate the production of the protein using Pfenex, alongside the use of a proprietary solvent extraction technology developed at Dow. Additional financial details of the agreement - or indeed the identity of Pfizer's drug - were not disclosed.
Pfenex can produce more protein per reactor than other fermentation systems and so should reduce costs, according to Nick Hyde, Dowpharma's global business director.
It also extends the range of proteins that can be made by microbial fermentation to include some biotherapeutics that would otherwise require mammalian cell culture. The expense of the latter - typically around twice the cost of microbial fermentation - means that mammalian systems tend only to be used if no microbial approach can be found, according to Hyde.
As a contract manufacturer, Dowpharma elected last year not to go ahead with plans to build a mammalian cell production facility at its Smithfield site in the US, which has since been closed, in favour of concentrating on technologies such as Pfenex that can enhance microbial fermentation.
And this decision now seems sensible - given recent market research from Frost & Sullivan which is predicting an overcapacity in biologics manufacturing out to 2011 - although it goes against the current axiom that CMOs should embrace biopharma as a way to combat the overcapacity and competition hitting pharmachem sector.
Pfenex is built around specially modified strains of P fluorescens that increase cellular expression while maintaining critical solubility and activity characteristics of recombinantly expressed therapeutic proteins.
In comparison to E coli and other expression platforms, it uses different pathways in the metabolism of certain critical sugars. Dow believesthese differences result in reduced production of metabolic byproducts that have been shown to negatively impact cell growth. In addition, the company has developed specific gene promoter and regulating systems that it claims further improve productivity.
"In the cases that we have tested, Pfenex consistently outperforms other commercially available microbial expression systems such as E coli," said Hyde.