Elevating mRNA Manufacturing Toward GMP-Readiness For Vaccine Candidate AfriVac 2121 (Wuhan) Under The WHO/MPP mRNA Technology Transfer Program

The mRNA Technology Transfer Program marks a transformative milestone in the global effort to democratize access to life-saving vaccines and therapeutics. Designed to address long-standing health inequities, particularly in low- and middle-income countries (LMICs), the program empowers regions to build their own mRNA production capabilities. A key driver of this progress has been the partnership between Merck KGaA, Darmstadt, Germany, and Afrigen. Their joint efforts have led to significant advancements in mRNA manufacturing, particularly through the optimization of tangential flow filtration (TFF). By refining membrane sizing, conducting scale-up studies, and implementing bioburden reduction strategies, the collaboration has successfully developed a GMP-ready mRNA production process. These innovations have resulted in high yields and robust scalability from research and development to full-scale production, all while preserving the integrity of the mRNA.

As the mRNA Technology Transfer Program continues to evolve, explore how these optimized processes serve as a blueprint for future technology transfer and capacity-building efforts.