Almac Scientists To Develop Novel Manufacturing Process For Essential Medicine

Almac Group, the global contract pharmaceutical development and manufacturing organisation, has been awarded $200,000 by the Bill & Melinda Gates Foundation (BMGF) to develop novel biosynthetic routes with the aim of substantially lowering the cost of selected steroidal Active Pharmaceutical Ingredients (APIs) and enable their use in developing world aid programs.

The programme of work will see the development of novel biocatalytic routes to Etonorgestrel and Levonorgestrel APIs by Almac Sciences’ established team of biocatalysis experts based in Ireland. Etonorgestrel is a highly potent material currently made with mid-twentieth century chemistry which makes it very expensive at almost $200k/kg and therefore unaffordable to women in the developing world. Almac aims to reduce the cost to just $5k/kg which will make a big difference for treating 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.

As a result of receiving this BMGF funding, the project will commence in January 2020 with the initial phase expected to last for at least three months.

Dr Mix commented: “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 have 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.”

About Almac Group
‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately-owned organisation that has organically grown over 50 years and now employs over 5,600 highly skilled personnel.

Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).

For more information, visit almacgroup.com.