Sterling Pharma Solutions Announces Exclusive Partnership to Develop Novel Route to Newly Approved COVID-19 Therapy

Sterling Pharma Solutions recently announced an exclusive partnership with the University of Manchester Institute of Biotechnology (MIB), to support the development of a novel, 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 chemical scale-up and process development expertise, which could potentially widen access of molnupiravir to lower-income countries in response to the global pandemic.

Molnupiravir was originally developed by Ridgeback Biotherapeutics and Merck Sharp and Dohme, and was approved by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on November 4, 2021, for the treatment of patients with COVID-19.

The new route has been developed by researchers at MIB, and includes the use of a novel enzyme, cytidine aminotransferase, which would reduce the manufacturing cost of the drug. The process has been transferred to Sterling’s UK facility in Dudley, Northumberland to scale up to multi-kilogrammes, which could then allow generic pharmaceutical manufacturers to produce large-scale quantities of molnupiravir for the supply of lower-income countries, subject to authorisation from further regulatory agencies, including the World Health Organization and national governments.

Sterling’s Chief Executive Officer, 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.”

 Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services. Sterling has four facilities employing more than 850+ people: its HQ in Dudley, Northumberland, UK; a dedicated ADC bioconjugation facility in Deeside, North Wales, UK; and two sites in the US, in Cary, NC, and Germantown, WI. Find out more.