The success of mRNA-LNP technology in enabling the rapid development and production of COVID-19 vaccines—and the recent approval of an RSV vaccine—has opened the door to a wide array of applications in vaccines and therapeutics targeting infectious and non-infectious diseases. Compared to traditional biologics, mRNA-based manufacturing offers a streamlined, cell-free process with a plug-and-play design, allowing for rapid adaptation of sequences and valencies across different vaccine candidates. This inherent flexibility provides significant advantages in terms of speed, scalability, and efficiency.
However, the platform’s reliance on several specialized raw materials—such as enzymes, nucleoside triphosphates, plasmid DNA, and lipids—introduces unique challenges. To fully realize the potential of mRNA technology, Chemistry, Manufacturing, and Controls (CMC) teams must establish robust, long-term strategies for sourcing, characterizing, and controlling these critical inputs.
This presentation will address essential considerations, including:
· Phase-appropriate quality and regulatory requirements
· Strategic sourcing and supply chain resilience
· Identification, characterization, and control of material attributes critical to process performance