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[View Image] B. Frank Gupton, Ph.D., founder and CEO of M4ALL and VCU Engineering’s Floyd D. Gottwald Jr. Chair in Pharmaceutical Engineering. (VCU College of Engineering)

Medicines for All Institute drives down production costs of investigational pill to treat COVID-19

The VCU College of Engineering institute’s new methods of manufacturing molnupiravir will expand global availability of the drug.

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Editor’s note: On Nov. 4, Britain became the first nation to authorize the use of molnupiravir to treat Covid-19.

The Medicines for All Institute in the Virginia Commonwealth University College of Engineering has developed low-cost manufacturing processes for molnupiravir, the first investigational pill to treat COVID-19, as reported in the recent release from the Bill & Melinda Gates Foundation. These new methods will expand global availability of the antiviral drug. 

Discovered by Emory University scientists, molnupiravir was developed by Merck in collaboration with Ridgeback Biotherapeutics. As an oral medication, molnupiravir can be administered early in the progression of COVID-19 and is believed to lessen the severity of the illness. 

The Medicines for All Institute has demonstrated multiple novel, efficient synthetic routes that can be used for the large-scale manufacture of molnupiravir. These processes are available to any manufacturer. Several of the institute’s routes rely on widely available starting materials. These routes are expected to prevent supply chain difficulties and reduce costs of molnupiravir. The institute’s efficient, high-yield enzymatic process requires only two chemical transformations, cutting the number of steps in half.

"We were fortunate to be in a position to work on this important treatment for COVID-19 during the pandemic. We have received numerous inquiries and are supporting global manufacturers to implement our processing technology," said B. Frank Gupton, Ph.D., founder and CEO of the Medicines for All Institute and the Floyd D. Gottwald Jr. Chair in Pharmaceutical Engineering. Gupton is also a professor and chair of VCU’s Department of Chemical and Life Science Engineering. 

Collaborators from the Massachusetts Institute of Technology, the Johannes Gutenberg University Mainz, Germany, and the University of Graz/RCPE GmbH, Austria, also helped Medicines for All design several viable synthetic routes to molnupiravir. 

In collaboration with the institute, TCG GreenChem Inc., a subsidiary of TCG Lifesciences, co- developed and demonstrated two of these synthetic routes at kilogram scale. “The two synthetic routes are highly complementary, safe and scalable. One utilizes biocatalysts built upon green concepts and the other uses highly efficient traditional nucleoside chemistry,” said Chris Senanayake, CEO and CSO of TCG GreenChem Inc.

These processes are available to any manufacturer.

Medicines for All has been driving down the production costs of drugs that fight HIV, malaria and tuberculosis since it was established at the VCU College of Engineering in 2017 with major funding from the Bill & Melinda Gates Foundation. In early 2020, the institute marshalled its resources to tackle the urgent new threat of the coronavirus. 

The institute’s manufacturing optimization process for lifesaving drugs reduces costs, increases efficiencies and spurs technical innovation to give competitive advantages in the production of essential medications. Medicines for All is also a recognized leader in the development of green chemistry methods to reduce waste and decrease pollution.

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