MilliporeSigma Announces Non-Binding MoU with Afrigen Biologics for Development of mRNA Vaccine Technology Platform

News Release

• Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization
• Contributes to expanding access to life-saving therapies in South Africa and low- and middle-income countries (LMICs)
• Objective is to improve regional manufacturing capacity and enhance global pandemic resilience

Burlington, Massachusetts, July 3, 2024 – MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced that the company’s Life Science business entered into a non-binding Memorandum of Understanding (MoU) with Afrigen Biologics to support the development of an mRNA vaccine technology platform. The collaboration is aimed at advancing mRNA platform manufacturing capabilities, scaling up production, optimizing processes, and providing troubleshooting expertise.

“Leveraging our comprehensive chemical portfolio and custom production capabilities, we offer cutting-edge experience for mRNA manufacturing, ensuring a seamless journey from research to production,” said Bert de Vet, Head of Commercial EMEA Process Solutions, Life Science business of Merck KGaA, Darmstadt, Germany. “Our alliance with Afrigen for mRNA technology platform development echoes our commitment to fostering equitable access to life-saving therapies for global health.”

As part of the MoU, the Life Science business will support Afrigen’s Center of Excellence and training initiatives aimed at building capacity in LMICs to produce mRNA vaccines and therapeutics. The mRNA technology transfer program, co-led by the World Health Organization (WHO) and the Medicines Patent Pool (MPP), is based on a South African consortium establishing and validating an mRNA manufacturing platform at a central site (the ‘hub’) and transferring the technology platform to partners.

The Afrigen-based mRNA vaccine tech transfer program will provide sufficient transfer of know-how to allow the current 15 recipient manufacturers in the program to produce and release mRNA vaccines at scale to support clinical development, national/regional marketing authorisation and WHO prequalification, and sustainable supply to meet local and regional vaccine demand.

“The mRNA vaccine technology transfer hub is well on its way to create a sustainable mRNA product innovation platform for public health benefit and pandemic preparedness. The platform at Afrigen provides access to mRNA technology for 15 partners in LMICs and straddles the entire vaccine value chain from R&D to Good Manufacturing Practices (GMP) manufacturing. Following the launch of the program in 2021, we have successfully developed mRNA vaccine technology R&D and production capabilities. Our progress has been greatly accelerated by the Life Science business sector’s technical expertise,” said Petro Terblanche, CEO of Afrigen Biologics.

Ike James, Head of Technology Transfer at Medicines Patent Pool, added, “What sets the mRNA technology transfer program apart is the exceptional collaboration among numerous partners, all dedicated to empowering LMICs to develop and manufacture the mRNA vaccines of the future. Today's MoU signing between Afrigen and the Life Science business of Merck KGaA, Darmstadt, Germany is a clear testament to this shared commitment and a significant step in this journey.”

The company’s Life Science business is one of the key players in driving mRNA technology forward, improving regional manufacturing capacity, and contributing to global pandemic resilience. The Life Science business’s comprehensive approach involves mRNA expertise, tech-transfer proficiency, regulatory knowledge, and product portfolios streamline manufacturing and testing.