When a pharmaceutical company identifies a development candidate, it must also determine a way of manufacturing it cost-effectively and reproducibly at scale. It is very important that the route of synthesis be efficient, flexible and ideally not require extreme or specialized conditions. Most importantly, it must robustly meet quality standards and deliver desired long-term economics.
Protein engineering makes it possible to optimize enzymes used in API manufacturing processes to improve product quality and streamline production in ways that are impossible with chemical catalysts and naturally occurring enzymes.
Although engineered enzymes are typically used to improve API manufacturing processes in pharmaceuticals, they may also have application in discovery. Sometimes chemical reactions can’t happen without an appropriate catalyst. A chemist may be able to imagine an innovative molecule and envision the chemistry to enable it. Then, using protein engineering, the molecule can be created as well as the manufacturing process to produce it for testing and commercial production.
A real-life example
Januvia® is a blockbuster drug for the treatment of Type 2 diabetes, manufactured by Merck. As the drug achieved increased commercial penetration, Merck was faced with building an additional manufacturing facility to keep up with demand, while also encountering capital expenditure challenges.
Januvia® is a registered trademark of Merck & Co, Inc.
Codexis worked collaboratively with Merck to develop a new enzyme catalyst to manufacture the drug more cost-effectively. The high-performing enzyme catalyst that Codexis engineered eliminated several steps from the manufacturing process, doubled the measured productivity of the process, decreased energy usage and significantly reduced capital expenditure requirements.
The evolutionary process
Beginning with a target performance objective, the CodeEvolver® rapid evolution process comprises in silico screening, the introduction of function-driven mutations, high-throughput assay screening and machine learning to identify productive pathways, as well as the human expertise of our scientific team. Each successive cycle produces incremental improvements that can be refined until the targeted performance is achieved.
Protein engineering experts
Since 2002, Codexis scientists have been unlocking the power of protein optimization and production. What sets Codexis apart is the speed and precision with which we optimize existing proteins or create entirely new ones. Even for drugs already on the market, Codexis’ optimized enzymes can help speed production, reduce waste and lower costs.