Under the non-exclusive deal – financial terms of which were not disclosed – AMRI will assess biocatalysis enzymes produced by Codexis using its Codeevolver platform for application in active pharmaceutical ingredient (API) and intermediate production.
Pete Michels, senior director of biocatalysis at AMRI, told in-Pharmatechnologist.com that although Codexis is only one of a number of firms whose enzymes the contract manufacturing organisation (CMO) is assessing, the firm had been impressed by what it has seen so far.
“We’ve found that the new generation of Codexis biocatalysts provide the best biocatalyst screening libraries for general synthetic use. AMRI is particularly impressed with the flexibility and fit with process goals and timelines.”
AMRI will assess the biocatalysts for use in the manufacture of APIs, intermediates and drug metabolites at its facilities in Albany and Syracuse continued Michels, adding that the firm will look at improving processes for both new and existing supply contracts.
“Of course [changes to] any existing routes would need to be validated and registered with FDA. The practical path for doing this for processes using biocatalysis is clear, and increasingly demonstrated through several recent FDA approvals, such as sitagliptin and atorvastatin.”
Pharma catalyst for growth
For Codexis the deal is all about expanding its presence in the drug industry according to Peter Seufer-Wasserthal, SVP of the firm’s pharmaceutical business.
“The main benefit for Codexis is that our products will be used in many more projects than we could do on our own. Working with a company like AMRI will help fill the opportunity pipeline for commercial supply of enzymes going forward.”
Codexis’ focus has changed in recent months following the end of its biofuel R&D agreement with Royal Dutch Shell last year. Since then the firm has repeatedly called its pharma business a key growth catalyst, which is something that Seufer-Wasserthal reiterated.
“The relationship with AMRI is seen as a growth opportunity for Codexis to further strengthen our footprint in the pharmaceutical industry,” he said, adding that “the pharma business at Codexis has grown over the last year and relationships like this will help accelerate this growth.”