By Vincenza Pironti, PhD & MBA, Global SME, Thermo Fisher Scientific, and Scott Emery, Global Commercial Director, Thermo Fisher Scientific
The rapid progression of mRNA-based COVID-19 vaccines from the laboratory to clinical reality validated the mRNA platform and stimulated substantial interest in its application for a wide range of indications. The unprecedented scientific innovation and cross-industry collaboration required to bring the vaccine to market signaled a paradigm shift in planning and execution that has the potential to speed the development of safe, high-quality mRNA-based products in the future. The shift entails eliminating nonessential steps, limiting non-GMP batch production, adopting new supply chain strategies, and performing several planning steps concurrently. Although there is some added risk, the benefits include streamlined development, early identification of challenges requiring manufacturing solutions, and the opportunity to address those challenges prior to full-scale manufacturing.