mRNA Impurity Analysis
Impurities are a challenge in mRNA quality control and require the development and validation of complex quality control assays to ensure safe and effective products. Creative Biogene is committed to providing comprehensive analysis and testing of mRNA products and possible impurities in the manufacturing process to ensure high quality mRNA for our clients.

Impurities in GMP mRNA Production Process and Their Hazards
Impurities that may be involved in the production of GMP mRNA include residual nucleic acids, proteins, endotoxins and microorganisms. The type and quantity of impurities not only seriously affect the safety, efficacy and quality of the product, but may also have a negative impact on the subsequent clinical application of the product. To reduce the risk of impurities, Creative Biogene strictly controls every step of the manufacturing process, including upstream and downstream processes, equipment maintenance and cleaning, personnel training and environmental monitoring, as required by GMP guidelines. Our professional quality control analysis team performs impurity testing at each stage of mRNA production, and records and analyzes the results and retrogrades to ensure the quality and safety of the final product.
Impurity Analysis of mRNA at Creative Biogene
| Testing Content | Testing Method |
| Residual DNA template | qPCR |
| Residual dsRNA template | ELISA |
| Residual protease (T7, capase, etc.) | ELISA |
| DNase residue | Fluorescent probe method |
| RNase residue | Fluorescent probe method |
| NTP/cap analog residues | HPLC |
| EDTA residue | HPLC |
Creative Biogene's experts offer a wide range of solutions for the determination of specific impurities in GMP mRNA production, ensuring that the products delivered to you meet regulatory standards and are safe, effective and quality assured. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
* For research use only. Not intended for any clinical use.