Since 2020, the new crown disease has swept the world. With the raging epidemic, the development and large-scale application of the new crown vaccine has become the eager expectation of the world. Many domestic and foreign pharmaceutical companies have invested in the research and development samples of the new crown vaccine. On November 16, Moderna reported that the effective data of its COVID-19 vaccine was 94.5% in the mid-term. On December 2, only two weeks later, BioNtech and its US partner Pfizer disclosed the news that the British drug regulatory authority had urgently approved it. Its co-developed COVID-19 mRNA vaccine BNT162b2, which is the first mRNA vaccine approved in history, is said to provide more than 90% protection. This part of mRNA vaccines has attracted widespread attention around the world, and the research of mRNA drugs has become a hot field.
Medicilon Biopharmaceuticals has long provided comprehensive support for the safety and effectiveness evaluation of various new biotechnology drugs and vaccines, and has also cooperated with Canadian companies such as Actuias for a long time to commit to the effectiveness of LNP-mRNA drugs and vaccines and above. We have accumulated rich experience in safety evaluation and analysis work, and established a sound biological analysis technology platform for new mRNA vaccines.
The mRNA vaccine introduces the mRNA prepared from the exogenous target gene sequence through transcription, synthesis and other processes into the cells of the body through a specific delivery system, directly expressing the target protein in the body, and stimulating the body to produce an immunological response, thereby enabling the body to obtain immune protection.
mRNA has the Following Characteristics:
It can be introduced into cells to express the corresponding antigen protein in vivo, avoiding the in vitro protein expression and purification process;
It can stimulate the immune system to produce humoral immunity and/or cellular immune response, and play corresponding immune prevention and/or immunotherapy effects;
It can enhance the body’s immune response ability or change the type of immune response by stimulating the body’s immune system to produce a variety of cytokines;
Since the degradation of mRNA is accomplished through normal cell metabolism, which reduces the potential risk of genetic mutations caused by infection or merger, this type of vaccine has its unique advantages.
Based on the mechanism and characteristics of mRNA vaccines, Medicilon Biotechnology’s Drug Analysis Department has established a coverage covering metabolism and biodistribution, to total antibodies, key sequence domain antibodies, and antiviral neutralization in order to support the safety and effectiveness evaluation of mRNA vaccines. A series of evaluation technology platforms for antibody titer and the efficacy of cellular immune response.
mRNA Level Biodistribution Analysis
Medicilon has the ABI7500 series real-time PCR expansion instrument and the supporting Kingfisher nucleic acid extractor equipment. The whole blood samples preserved by Trizol and other types of tissue samples can be collected through the RNAase free tube to carry out the metabolism and metabolism of mRNA by the subsequent RT-qPCR technology. Distribution analysis.
Biodistribution analysis of mRNA expression protein antigen
The mRNA vaccine needs to be translated into protein in the body to stimulate the body to further produce an immune response, so it is particularly important to confirm the expression level and distribution of mRNA at the protein level.
Medicilon Biopharmaceutical Analysis Department has multiple molecular devices M4 series microplate readers and new iD5 series microplate readers, MSD series electrochemiluminescence analyzers, etc. It supports multiple types of immunoassay methods, which can perform the protein antigen level translated by mRNA. Detection and monitoring of different sensitivity ranges.
- Enzyme-linked immunoassay (EIA)
- Fluorescence immunoassay (FIA)
- Time-resolved fluorescence (TRFIA)
- Fluorescence resonance energy transfer (FRET)
- Chemiluminescence (CLIA)
- Electrochemiluminescence (ECL)
Microplate reader and electrochemiluminescence analyzer used in the experiment
Evaluation of T cell factor secretion level
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. Medicilon Biotechnology’s drug analysis department has multiple cytokine analysis platforms such as MSD, luminex, FACS CBA, etc., to save samples and save The cost model of cytokine analysis technology supports, and even the local cytokine abundance change analysis of ELISPOT single cell.
MSD Multi Plex
Total antibody, key domain antibody titer analysis
Conventional B cell secretion antibody titer evaluation is mainly based on the indirect ELISA titer detection method. The core members of the Medicilon technical team engaged in nucleic acid and protein vaccine product research in the early years, obtained relevant patents, and received vaccines in the American pfizer company A series of trainings on the evaluation of titer bioanalysis have established a series of method evaluation systems and standard-setting rules based on practical experience, which are used to check the total antibody of the vaccine, the antibody titer of key domains and evaluate their relevance. Medicilon Biotechnology’s drug analysis department can also use the validated kit based on the MSD platform to directly perform SARS-CoV-2 five different important 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 Spike IgG, IgM, IGA detection.
- V-PLEX SARS-CoV-2 Group 1 (IgG)
- V-PLEX SARS-CoV-2 Panel 2 (IgM)
- V-PLEX SARS-CoV-2 Panel 3 (IgA)
Neutralizing antibody analysis based on competitive analysis or pseudovirus
Medicilon vaccine analysis technology platform can not only use the electrochemiluminescence MSD platform to apply competitive ligand binding analysis methods to perform, for example, the analysis of functional antibodies stimulated by the expression of antigens in the new coronavirus mRNA vaccine, ie neutralizing antibodies, but also independent cells. Room and other facilities to perform neutralizing antibody analysis based on the interaction between pseudovirus and ACE2 expressing cell line.
Introduction of Medicilon R&D platform:
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