mRNA Vaccine Bioanalysis Platform

mRNA vaccine transport mRNA obtained from target gene expression into cells through a specific delivery system. Then, the mRNA will directly express the target protein in the body to stimulate the specific immune response, , so that the body can obtain protection from the immune system.. mRNA has the below characteristics:

Therefore, the mRNA vaccine has its unique advantages.

Based on the mechanism and characteristics of mRNA vaccines, Medicilon’s Bioanalysis Department has established an evaluation platform covering metabolism and biodistribution, key sequence domain antibodies and antiviral neutralizing antibody titers and the evaluation of effectiveness of cellular immune response.

Medicilon equips with the ABI7500 Real-Time PCR System and the Kingfisher Nucleic Acid Extractor.  The blood samples stored in Trizol and other types of tissue samples collected from RNAase free tubes can be used for mRNA metabolism and distribution analysis by subsequent RT-qPCR technology. 

The mRNA vaccine needs to be expressed to stimulate the body for immune response, so it is particularly important to confirm the expression level and distribution of mRNA at the protein level.  

Medicilon’s Bioanalysis Department has equipped with several M4 Series Microplate Readers and iD5 Series Microplate Readers of Molecular Devices.  The MSD series electrochemiluminescence analyzer supports various types of immunoassay methods and could perform detection and monitoring of different sensitivity ranges of protein antigen levels translated by mRNA.

In addition to the production of antibodies by the humoral immune response of B cells, the mRNA vaccine can also stimulate the immune response of cells.  The Bioanalysis Department of Medicilon has multiple cytokine analysis platforms such as MSD, luminex and FACS CBA to provide sample-saving and cost-saving cytokine analysis technical support.  Medicilon even provides the analysis of ELISPOT single-cell level cytokine abundance change.

The routine evaluation of antibody titer secreted by B cells is mainly based on the indirect ELISA titer detection method.  The Medicilon team devoted to the research of nucleic acid and protein vaccine products in the early years, obtained related patents and received a series of trainings on the biological analysis and evaluation of vaccine potency in Pfizer in the United States.  Based on practical experience, a series of method evaluation systems and standard-setting rules have been established to investigate the antibody and key domain antibody titers of the vaccine and evaluate their relevance.  Base on the MSD platform, Medicilon’s Bioanalysis Department could also use the validated kit to perform IgG, IgM, IGA inspection of five different SARS-CoV-2 mRNA expression antigens, SARS-CoV-1 Spike, SARS-CoV-2 N, SARS -CoV-2 S1 NTD, SARS-CoV-2 S1 RBD, and SARS-CoV-2.

The Medicilon vaccine analysis platform could use the electrochemiluminescence MSD platform to apply competitive ligand binding analysis, such as the analysis of functional antibodies stimulated by the expression of antigens in the new coronavirus mRNA vaccine.  There are also facilities such as independent cell rooms for neutralizing antibody analysis based on the interaction between pseudoviruses and cell lines ACE2.