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During the production of GMP mRNA, it is critical to ensure the purity of the mRNA, which is an important guarantee for the safety, efficacy and reliability of the final product. Creative Biogene's experts provide comprehensive, accurate characterization of mRNA purity by combining traditional quality control methods with a variety of advanced analytical instruments to ensure product safety and efficacy.
Purity identification is the process of determining the quantity and quality of mRNA molecules, and it is an important part of GMP production. The purity of the mRNA being produced must be high, as contamination of the molecules can lead to the production of non-functional or potentially harmful products. For example, contaminated mRNA can cause an immune response that can render an mRNA-based therapy or vaccine ineffective and may even lead to adverse reactions in the recipient. In addition, the purity of mRNA is critical to the reproducibility of GMP production. Consistency in the production of high-quality mRNA ensures that the final product is safe, effective, and reliable.
The purity of mRNA was characterized by measuring the absorbance value of mRNA at 260 nm by UV spectrophotometer to calculate the RNA content.
The cap structure can enhance the stability and translation efficiency of mRNA. The detection of mRNA cap rate is one of the most critical indicators in the quality analysis of mRNA production process. Creative Biogene uses enzymatic cleavage to obtain oligonucleotide sequences with or without cap at the 5' end, and then separates oligonucleotide fragments of different sizes by denaturing polyacrylamide gel electrophoresis (PAGE), high performance liquid chromatography (HPLC) or liquid phase mass spectrometry (LC- MS) to separate oligonucleotide fragments of different sizes and thus quantitatively assess the rate of mRNA capping.
The capping efficiency and properties of Poly(A) tail lengths need to be carefully monitored, as any variation may have adverse effects. For example, changes in Poly(A) tail length have been associated with changes in product potency. Creative Biogene evaluates the structural characteristics of mRNA by sophisticated methods and instrumentation and involves digestion of mRNA with enzymes that isolate the relevant 3' or 5' ends and analysis using chromatographic methods combined with UV and MS detection.
| Methods | Description |
| Gel electrophoresis | The sample size requirement is not high, but the application is susceptible to factors such as fragment size and gel resolution, which in turn leads to poor sensitivity and time consuming, and is usually used for early qualitative studies. |
| Liquid chromatography (HPLC) | The product purity and integrity of mRNA is characterized by transforming changes in the composition and content of different sample effluents into electrical signals, which are measured by electronic instrumentation, leading to qualitative quantification. It is often used in combination with other methods for the joint capping of mRNA. |
| Liquid chromatography mass spectrometry (LC-MS) | The assay is accurate and fast for sample analysis and can be verified with high accuracy when characterizing mRNA purity. |
| Immunological assays | Immunological methods like western blotting or northern blotting can be used to confirm the presence of the desired mRNA molecule in a sample. These methods involve separation of RNA on a gel followed by transfer to a membrane and detection by using specific antibodies against the target mRNA. |
Creative Biogene has a variety of advanced mRNA purity monitoring tools to accurately and rapidly characterize the purity of mRNA, ensuring high quality mRNA products for our clients. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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