Almac Group, a global contract pharmaceutical development and manufacturing organization, has been awarded $200,000 by the Bill & Melinda Gates Foundation (BMGF) to develop novel biosynthetic routes with the goal of substantially lowering the cost of selected steroidal Active Pharmaceutical Ingredients (APIs) and enable their use in developing world aid programs.
 
Almac’s biocatalysis experts based in Ireland will work to develop novel biocatalytic routes to Etonorgestrel and Levonorgestrel APIs. Etonorgestrel is a highly potent material currently made with mid-twentieth century chemistry making it expensive at almost $200k/kg. Almac aims to reduce the cost to $5k/kg making it more affordale to patients in the developing world.
 
Almac’s proposed new route investigation builds on established methods for Norgestrel and Etonorgestrel, using a common and less expensive steroid pre-cursor starting material. Dr Stefan Mix, Head of Biocatalysis, Almac Sciences, who developed the idea, will lead a team of three dedicated scientists through the initial proof-of-concept (PoC) stage. Upon successful completion of the PoC, the team will increase in size involving additional biologists, biocatalysis chemists and API chemist resources over the next two years.
 
Dr. Mix said, “Biocatalysis has firmly established itself as key technology in the pharmaceutical sector for more efficient and sustainable API manufacturing processes, which in turn enable lower drug prices. Almac has been pursuing this technology for many years, rewarded by its successes with rapid development of new medicines and better processes for existing drugs. We are very pleased to have the opportunity to work with BMGF in deploying Almac’s biocatalysis expertise to make essential medicines more affordable for humanity.”