Title:CMC and QMS Regulatory Requirements and Challenges for mRNA-based Vaccines
Volume: 20
Issue: 2
Author(s): Surbhi Tyagi, Vikesh Kumar Shukla*Sandeep Arora
Affiliation:
- Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, 201313, India.
Keywords:
Biologics, vaccine, mRNA vaccine, mRNA production, adventitious agents, chemistry, manufacturing, controls, quality, quality management system.
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.
