T7 RNA Polymerase Detection Kit (Enzyme-Linked Immunosorbent Assay • One-step Method)

T7 RNA polymerase is encoded by the DNA of T7 phage and is a DNA-dependent RNA polymerase that can catalyze RNA synthesis starting from the T7 promoter sequence in the 5 '→ 3' direction. It is often used in mRNA drug development to catalyze the in vitro synthesis of target genes.
The "Technical Guidelines for Pharmaceutical Research of mRNA Vaccines for the Prevention of the Novel Coronavirus (Trial)" issued by CDE points out that the entire process needs to be subject to quality control to ensure its effectiveness, safety and controllability. T7 is recommended in the characterization and release testing of mRNA drugs under the United States Pharmacopeia (USP).
This product uses the ELISA double antibody sandwich method to determine the content of T7 RNA polymerase in the sample. Anti-t7 RNA polymerase antibody is coated on the solid-phase carrier microplate. Standard substances or samples to be tested are added, and the T7 RNA polymerase detection antibody is added to form an antibody-antigen-detection antibody complex. The content of T7 RNA polymerase in the samples to be tested is quantitatively detected by color development.
This series of reagent kits has undergone comprehensive methodological validation in accordance with relevant regulations, guidelines and other document requirements, and can provide performance validation reports.

Quality evaluation of mRNA drugs in the drug development quality control and CMC quality control stages