CMC and QMS Regulatory Requirements and Challenges for mRNA-based Vaccines

Abstract

Biopharmaceuticals differ significantly from chemical drugs, and thus their CMC regulatory compliance is distinct from them. The development of biologicals, like mRNA vaccines, holds promise for preventing infectious diseases and generating an antigen-specific immune response. These vaccines are a better option than traditional vaccination methods because of their significant potency and swift and affordable manufacture. The compliance strategy is shaped by evaluating resource allocation and risk tolerance. This review examines the CMC regulatory requirements concerned with the manufacturing of biologics, particularly mRNA vaccines. The many challenges that could arise when producing biological products are also discussed in this paper, like the introduction of adventitious agents that can affect the safety of the product and the molecular designs of mRNA molecules, which may need to be optimized for higher protein expression and improved structural stability. By implementing the Quality by Design approach during the development, a better understanding of the controls and risk management should be utilized to minimize the risk and improve compliance