RNase Inhibitor can specifically inhibit the activities of RNase A, B, and C by forming a 1:1 complex with RNase, thereby suppressing its activity. During the production of mRNA vaccines, RNase Inhibitor effectively inhibits the potential RNase activity in the reaction system, protecting the mRNA from degradation. According to regulations, it is necessary to conduct various residue detections on the mRNA vaccine substances, among which RNase Inhibitor, as a protein product, falls into the category of protein residue detection items, so its residue amount needs to be quantitatively detected. This kit uses double antibody sandwich enzyme-linked immunosorbent assay (ELISA) to detect RNase Inhibitor, which can detect and quantitatively analyze the content of RNase Inhibitor with high sensitivity and specificity.

Tscm Expander® is a mixing of cytokines (IL-7, IL-15, etc.) at a certain proportion. It specifically expands the T-memory stem cells and significantly extends the in vivo post-infusion survival time of T cells with specific killing ability, thus remarkably improving the efficacy of immune cell therapy against the tumor. In the traditional cell expansion procedures, after the monocytes activated by CD3/CD28 monoclonal antibodies are further expanded by IL-2, the majority of T cells highly differentiate to effector/memory T cells. These cells are weak in self-renewal ability with short post-infusion survival time in vivo, resulting in poor therapeutic effects. Tscm Expander® takes the place of IL-2 in the expansion of activated T cells so that 30% of the expanded T cells are transformed into T-memory stem cells. This greatly prolongs the post-transplant survival time of immune cells in vivo and improves the therapeutic effect. The T memory stem cell expanders of Tscm Expander® are produced with raw materials of pharmaceutical applicable level. The host protein residue, nucleic acid residue and common pathogens are strictly controlled, and the production and quality management procedures of the product comply with GMP regulations to ensure the traceability of the production process and all raw materials.

As a biological macromolecule, mRNA can be synthesized on a large scale by in vitro transcription (IVT). T7 promoter is one of the most efficient promoters at present. Therefore, T7 RNA polymerase can be used for in vitro transcription to obtain more synthetic products. As one of the by-products of in vitro transcription, dsRNA can be recognized by the corresponding nucleic acid receptors, triggering a natural immune inflammatory response, which seriously affects the effectiveness of mRNA vaccines and needs to be strictly controlled during the production process. T7 RNA polymerase obtained through molecular evolution. It can significantly reduce the dsRNA impurities, thereby reducing the autoimmunogenicity of synthetic mRNA. The polymerase is GMP Grade produced in E. coli. Our manufacturing processes are strictly controlled to ensure the end products free from host protein or nucleic acid contaminations and other impurities following the Pharmaceutical Manufacturing Guidelines. We guarantee the manufacturing and quality control comply with GMP regulation for tracking each and every step of the manufacturing process, including raw material sourcing.

T7 RNA Polymerase is a DNA-dependent 5'→3' RNA polymerase that highly specifically recognizes the T7 promoter sequence. It uses double-stranded DNA containing the T7 promoter sequence as a template and NTP as a substrate to synthesize RNA complementary to one strand of DNA. The transcribed RNA can be used for downstream applications such as RNA structure and function research, RNA enzyme protection, probe hybridization, RNAi, microinjection and in vitro translation. In the production process of mRNA drugs, according to regulations, it is necessary to conduct various residue detections on the mRNA vaccine substances, among which T7 RNA polymerase, as a protein product, falls into the category of protein residue detection items, so its residue amount needs to be quantitatively detected.