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The remarkable success of SARS CoV-2 mRNA-based vaccines and the ensuing interest in mRNA vaccines and therapeutics have highlighted the need for a scalable clinical-enabling manufacturing process to produce such products, and robust analytical methods to demonstrate safety, potency, and purity. Creative Biogene combines our powerful technology platform, advanced cGMP-grade production facilities, and extensive experience in mRNA synthesis to provide GMP-grade mRNA production services to our global clients to meet their project demands.
We offer GMP-grade mRNA production services to help our clients progress in project development and research in the following fields:
Creative Biogene can provide clients with one-stop solutions for GMP-grade mRNA production from research to clinical trials, starting from DNA template design and synthesis of mRNA sequences. Our customizable process production can meet any of our clients' demands, providing high-quality mRNA that meets standards and is capable of delivering milligram quantities to multi-gram quantities. Our services include:
Plasmid DNA is the starting material for mRNA production, and the plasmid vector contains the specific promoter of RNA polymerase and the sequence information of the final mRNA product. mRNA is prepared by linearizing the plasmid with restriction endonuclease, and then purified by multi-step chromatography and ultrafiltration process, and the tested linear DNA can be used for subsequent mRNA production.
Creative Biogene can perform mRNA sequence design and optimization according to your needs, and provide ab initio design and production services for GMP-grade plasmid production and linearized template preparation.
Since different production requirements have different needs for mRNA production, the production process needs to be optimized prior to full-scale production to ensure the highest yield and purity of mRNA production while minimizing costs. creative Biogene has the experience to provide in vitro transcription of mRNA, mRNA modification and mRNA purification services. This ensures that we can provide our customers with high quality mRNA products.
Quality testing of mRNA stock solutions is an important part of the manufacturing process. creative Biogene provides comprehensive, professional QC analysis during the development and production of mRNA therapeutics, including:
Creative Biogene's GMP mRNA standard production process is flexible and can provide milligram to gram scale production. Our mRNA production mainly involves the following steps. Creative Biogene's strong development capabilities can provide customized solutions to meet the different needs of our customers at any stage of GMP mRNA production.
Creative Biogene has strong GMP mRNA manufacturing capability, quality system and technical support to successfully help customers advance their project development process. If you are interested, feel free to contact us and one of our R&D experts will discuss your project, expectations and timeline.
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