Biotechnology firm Codexis says it has reached an important development milestone in its effort to design a biocatalytic process to produce a key intermediate for a Schering-Plough drug, reducing manufacturing costs and environmental waste.
The Californian company wants to use its MolecularBreeding process re-engineering platform to create a superior biological catalyst that will be used in the production of an undisclosed human therapeutics compound developed by Schering-Plough.
Biocatalysts are used to simplify and lower the cost of a variety of chemical transformations and are of particular interest in manufacturing chiral or single-enantiomer compounds.
Be they enzymes or fermentation strains, these catalysts are crafted specifically for chemical processes that can enable pharmaceutical process development, shorten process development timelines, dramatically improve existing manufacturing processes and increase chemical development productivity.
Codexis estimates that its platform technology can reduce cost of goods by 40 to 70 per cent and capital expenditures by over 35 per cent.
Furthermore, this platform technology can create new intellectual property opportunities, which can help extend the lifetime of drug products.
"The agreement with Schering-Plough was announced in March and Codexis has quickly met the initial development milestone," said Codexis CEO Alan Shaw.
"We are very pleased with this substantial progress in our collaboration and look forward to continuing to demonstrate the value of our technology to this important partner."
Codexis' platform technology begins with the selection of genes or genomes with DNA sequence diversity.
These gene or genomic variants are then subjected to a proprietary technique that recombines, or "shuffles," the DNA.
The resulting library encoding for novel biocatalysts is screened for those possessing desirable and improved properties and this process is repeated several times until the resulting enzymes or strains meet or exceed the target performance.
Those cell lines demonstrating improved performance under manufacturing conditions are then transferred to partners for validation and scaled up for commercialisation.
The MolecularBreeding protein and strain engineering technology platform has proved a major boon for Codexis, landing it development deals with major industry players such as Pfizer, Teva, and Bristol-Myers Squibb.
Codexis' future also looks bright as more and more drugmakers are turning to technologies that can offer a competitive advantage in manufacturing, particularly in the production of intermediates and active pharmaceutical ingredients (APIs).