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The characteristics of mRNA, such as high precision synthesis, easy degradation and difficult preservation, make mRNA face complex challenges in production process control, large-scale preparation process and quality control. In vitro transcription (IVT) is a more efficient way to synthesize mRNA in bulk. Creative Biogene's simple and fast mRNA manufacturing workflow offers more opportunities for personalized drug development. Our mRNA production uses high volume in vitro transcription systems and optimized purification methods to ensure high yields of pure and intact mRNA for our clients.
In vitro transcriptional synthesis is a relatively complex enzyme-catalyzed process. The program can synthesize RNA molecules of any sequence, from short oligonucleotides to several thousand bases, in quantities from μg to mg, under the guidance of a template. It is based on a gene template, including a promoter sequence upstream of the sequence of interest, which is then transcribed with the corresponding RNA polymerase. The synthesized in vitro transcripts are used in analytical techniques, structural studies, biochemical and genetic studies, and as raw materials for biopharmaceuticals.
During the synthesis of mRNA, in addition to the DNA template, the required enzymes, nucleotides and other relevant reagents are added. To ensure process stability, our experienced R&D staff usually use the design of experiments (DoE) method for process optimization and scale-up step-by-step (e.g. from 1mL-50mL-500mL-5L scale-up path) to achieve a steady increase in yield.
Although enzymatic synthesis techniques are more mature in the biomanufacturing industry (commonly used to synthesize peptides, DNA, RNA, small molecule compounds, etc.), developers still face the following challenges in the transcriptional synthesis of mRNA:
The production of mRNA stock solutions by efficient in vitro transcriptional synthesis (IVT) is an important tool to reduce process development and production costs. Creative Biogene has an advanced fully automated in vitro transcriptional synthesis platform that enables efficient mRNA manufacturing from small pilot development to scale-up production. Our fully automated synthesis reactors are highly reproducible and stable, allowing for features such as precise temperature control and programmed automatic dosing, avoiding errors caused by manual operation and ensuring consistency between production batches.
Creative Biogene has extensive experience in synthesizing mRNA through in vitro transcription. We have developed a well-established process for rapid turnaround of your mRNA production projects to deliver high quality mRNA products. 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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