Sterling Pharma Solutions, a global CDMO, has announced an exclusive partnership with the University of Manchester Institute of Biotechnology (MIB), to support the development of a low-cost manufacturing route to molnupiravir, a new anti-viral drug for the treatment of COVID-19.
Manchester University, which has received grant funding from the Bill and Melinda Gates Foundation for this project, has engaged Sterling to provide scale-up and process development services, which could potentially improve access of the drug for lower-income countries.
Molnupiravir was originally developed by Ridgeback Biotherapeutics and Merck Sharp and Dohme, and was approved by UK’s MHRA in November, 2021 for the treatment of patients with COVID-19.
The route developed by researchers at MIB includes the use of a novel enzyme, cytidine aminotransferase, which would reportedly reduce the manufacturing cost of the drug. The process has been transferred to Sterling’s UK facility in to scale up to multi-kilogrammes, which could then allow generic pharmaceutical manufacturers to produce large-scale quantities of the drug for the supply of lower-income countries, subject to authorisation from further regulatory agencies, including the World Health Organization and national governments.
Sterling’s CEO, Kevin Cook, said: “Sterling has extensive experience in process scale up and integrating biocatalytic steps into chemical syntheses, and we are incredibly proud to have been selected as the exclusive development partner on this project, which has the potential to help improve global access to this breakthrough treatment in the ongoing fight against COVID-19.”