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Many key quality attributes of mRNA (including plasmid and mRNA identification, purity and product-related impurities, process-related impurities, safety, and stability) determine its safety and efficacy, and require a professional and compliant analytical quality control program to ensure GMP mRNA production. Creative Biogene provides comprehensive, professional quality analysis testing throughout the mRNA production process. We offer a wide range of GMP-compliant quality tests and characterizations that can meet the demands of all phases of research, providing our customers with high-quality mRNA products.
The many critical quality attributes of mRNA determine its safety and efficacy and require professional and compliant analytical quality control to safeguard mRNA vaccine and drug development and production. mRNA quality can be assessed using a variety of techniques, such as gel electrophoresis and high-performance liquid chromatography, while the use of sequencing technologies or next generation sequencing ensures identity. The presence of residual amounts of DNA, enzymes and solvents as well as dsRNA and truncated RNA fragments must be determined. In addition, as a general quality control, aspects such as the presence of endotoxin, overall sterility and mRNA stability must also be evaluated.
Creative Biogene develops and performs a complete suite of analytical methods for mRNA quality control to monitor critical quality attributes, process-related residues and safety of GMP mRNA production processes. We offer both standardized and customized quality analysis testing solutions. The details of quality testing and characterization can be determined in consultation with the client based on their project requirements. The main components include the following:
Appearance, RNA length (capillary electrophoresis), RNA length (agarose gel electrophoresis), Poly A length, RNA content, PH.
A260/280, cap addition efficiency, polyA tail length, purity (capillary electrophoresis).
Endotoxin, bioburden, mycoplasma.
Residual dsRNA, residual protein, agarose gel, DNase and RNase assay.
We provide comprehensive analytical and testing services for impurity monitoring during the intermediate process of mRNA production and mRNA stock solution release.
We have accumulated extensive experience in mRNA quality control analysis.
Our talented research team has many years of experience in mRNA development, production and analysis.
We have a variety of advanced instruments for mRNA quality analysis, such as mass spectrometry, chromatography, capillary electrophoresis, UV spectrophotometer, qPCR, enzyme marker, flow cytometry, etc.
At Creative Biogene, we have an experienced quality analysis control team. By combining advanced analytical techniques with GMP mRNA manufacturing, our experts provide total quality control solutions to ensure that our customers are provided with high-quality products that meet safety, efficacy, and consistency requirements. 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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