mRNA Quality Control Services

Synthetic modified mRNAs have been shown to be viable and safe, providing the basics for gene therapy and vaccine. As a new alternative approach to address diseases, the mRNA-based drug not only benefits from the therapeutic advantages of the modality, but also the relative ease in production and scales. To support mRNA-based drug research and development and ensure safe and efficacious production, a strategic science-led service is required that identifies critical attributes to enable their evaluation and, ultimately, their quality. With years of professional experience, Creative Biogene has successfully launched an mRNA quality control (QC) platform with high-end technologies to detect and evaluate the synthetic mRNA. We are dedicated to ensuring the safety, efficacy and quality of customers’ mRNA-based drugs.

mRNA quality control (QC)

mRNA Quality Control

mRNA can be yielded by in vitro transcription from DNA templates using phage RNA polymerase. The synthetic process is accompanied by impurities generation. For example, double-stranded RNA (dsRNA), a major contaminant impurity, can trigger a strong immune response that influences the function of mRNA. Advanced development in chemical modification and delivery technology greatly improved mRNA's stability and translation efficiency. However, monitoring the quality of mRNA synthesis is a vital step toward mRNA production, which can greatly influence mRNAs' performance. Traditional methods such as nucleic acid electrophoresis are relatively rough, which can easily degrade mRNA. Creative Biogene provides a series of advanced techniques for mRNA quality control to satisfy global customers' needs with consistent high-quality mRNA.

mRNA quality control service in Creative Biogene

QC testing is essential to determine mRNA's stability, translation efficiency, and potential immunogenicity for downstream applications. We use an automatic nucleic acid fragment analyzer to detect the distribution of nucleic acid fragments. The advantage of the instrument is that it can quickly and efficiently complete the analysis of mRNA samples with different detection fluxes. Therefore, our service can be flexibly applied to the detection needs of our customers with different production scales. Besides, we also provide other analytical methods, such as HPLC, LC-Mass, and more. We have been exploring new analytical and testing methods for mRNA quality control. We can also provide the following services. If your service of interest is not listed, please contact us.

Standard QC tests Customized QC tests
The identity tests of mRNA The potency of mRNA
mRNA physicochemical property detection  
The purity and integrity of mRNA Microbial contamination detection
mRNA capping and tailing efficiency  
 Residual DNA template and dsRNA Bacterial endotoxins test

Advantages of our service

  • Professional and reliable service
  • Flexible and scalable QC testing
  • Custom tailored analytical methods and testing
  • Practices continual improvement

In Creative Biogene, we believe in the power of professionalism. Based on skillful experts and state-of-the-art analytical technology, we can help worldwide clients confidently assess batch to batch manufacture and process repeatability as well as the quality of mRNA produced. If you are interested in our service, please contact us as soon as possible. We are looking forward to serving you!

For research use only. Not intended for any clinical use.
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