mRNA Manufacturing Readiness for Vaccine Production

This white paper discusses the mRNA Technology Transfer Programme initiated by the World Health Organization (WHO) and Medicines Patent Pool (MPP) in 2021, aimed at addressing global inequities in vaccine manufacturing in response to the COVID-19 pandemic. It outlines the establishment of mRNA vaccine production capabilities in Low- and Middle-Income Countries (LMICs) to enhance local autonomy in public health. The paper details the collaboration between Afrigen, a South African biotechnology company, and Merck KGaA, Darmstadt, Germany, focusing on overcoming challenges in developing an mRNA manufacturing platform. Key objectives include platform development, establishing GMP-compliant facilities, and enabling human capacity. The document also highlights the critical role of tangential flow filtration (TFF) in the mRNA production process, addressing specific challenges related to scaling up production and optimizing filtration steps. Milestones achieved include the successful evolution of the production process from lab-scale to clinical trial batch production within two years.