Analysis of Important Factors about Quality Control of Raw Materials and Stock Solution of mRNA Vaccines for the Prevention of Infectious Diseases
Objective:To provide references for the quality control of such products in China by combing and summarizing the key points of quality control of raw materials and stock solution of mRNA vaccines for preventing infectious diseases.Methods:By combing the World Health Organization(WHO)and relevant standards and review agencies on the quality control guidance documents for raw materials and stock solution of mRNA vaccine for prevention of infectious diseases,and related regulatory guidelines and literature,the key quality control attributes and related requirements of raw materials and stock solution of mRNA vaccines for the prevention of infectious diseases were summarized.Results and Conclusion:As a new biological product,the nucleic acid structure of mRNA vaccines and the characteristics of liposome encapsulated preparations determined the quality control characteristics of this vaccine.Sequence and integrity,quantity and purity,percentage capping and percentage encapsulation were the key quality parameters unique to mRNA vaccines,which determined efficacy and safety.Establishing multiple quality control points and detection methods related to mRNA characteristics from the preparation stage of raw materials and stock solution will help ensure the safety,effectiveness,and controllable quality of mRNA vaccines for preventing infectious diseases.
infectious diseasesmRNA vaccineWHOquality controlanalysis of key points
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