Contract development and manufacturing organization (CDMO), Almac Group announced it was awarded $1m (€0.9m) in order to develop new biosynthetic routes, which would help lower the cost of selected steroidal active pharmaceutical ingredients (APIs).
A spokesperson for the company told us that the company has already received $200,000 in funding from Bill and Melinda Gates Foundation for this project, which “has a potential scope of $1m."
More specifically, the program refers to etonorgestrel and levonorgestrel, two APIs most commonly used in birth control drug products.
Almac’s team of biocatalysis scientists, which is based in Ireland, will initially work to develop a proof of concept for a production method based on biocatalysis, which utilizes a cheaper steroid precursor starting material compared to established production processes.
Stefan Mix, the company’s head of biocatalysis, commented that biocatalysis has the potential to support more efficient and sustainable API manufacturing processes, ultimately enabling lower drug prices.
According to the company, with current production methods, etonorgestrel’s cost is approximately $200,000 per kg, while Almac’s proposal can reduce it to $5,000 per kg, making it affordable for the developing world, and assisting the Gates Foundation’s aid programs.
Almac’s work under the funding will begin in January 2020, with the initial phase expected to last three months. Subsequently, the team will be enhanced with biologists, biocatalysis chemists and API chemist resources to further develop the production process over the next two years.