Regulatory Expertise And CMC Document Preparation To Support mRNA-Based Therapeutic Development

Navigating the clinical trials process to bring a molecule to market comes with numerous challenges, including meeting the regulatory standards required for the approval of new mRNA-based drug products. A key component of this process is the development of extensive chemistry, manufacturing, and controls (CMC) documentation, which outlines the quality of both drug substance and drug product. These documents are required for investigational and commercial applications.

Partnering with a contract testing, development, and manufacturing organization (CTDMO) can be highly beneficial, as they can assist with the accurate preparation of CMC documentation. An experienced CTDMO aids in reducing the risk of regulatory setbacks that might lead to delays and increased workload. This type of support is particularly important for mRNA drug products, which require detailed information about the mRNA, lipid excipients, and lipid nanoparticles (LNPs).

This article explores the regulatory requirements for mRNA drug substances and products, emphasizes the importance of phase-appropriate quality, and provides insights on creating CMC documentation to ensure compliance.