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mRNA Manufacturing

As the complexity of mRNA drugs increases, the mRNA manufacturing process will continue to evolve. The process of developing new mRNAs can be complex, and there are hidden obstacles in this process. Creative Biogene has developed a complete workflow for mRNA production, providing high quality and cost-effective mRNA production services to accelerate your GMP mRNA production research.

mRNA Manufacturing

Our Services

Creative Biogene has high-end mRNA scale up production facilities and various advanced purification methods. We have developed a comprehensive set of in vitro mRNA synthesis, modification and purification services for high quality mRNA production. Our mRNA production meets strict GMP quality control standards to ensure mRNA quality and expression efficiency.

mRNA ManufacturingFig. 1 Structure of in vitro transcribed (IVT) mRNA and commonly used modification strategies. (Wadhwa, A, et al., 2020)

We provide you with high quality services in the following mRNA development lifecycle:

In Vitro Transcription of mRNA

In vitro transcription is an important step in mRNA production. In vitro transcription, which is commonly used to produce mRNA, is a complex enzymatic reaction. mRNA is produced by what is known as in vitro transcription (IVT) and cotranscriptional capping. In vitro transcription (IVT) and co-transcriptional capping are the process steps for mRNA production. Creative Biogene offers flexible production processes using a variety of advanced automated synthesis equipment to facilitate the changing demands of our clients.

mRNA Modification

mRNA modification is an important technical embodiment of mRNA biologics and has a significant impact on the stability of mRNA products and their therapeutic use in the clinic. Creative Biogene has developed a variety of mRNA modification technologies, including:

  • Synthesis of "cap"-like structures and "capping enzymes" to stabilize mRNA.
  • Adding regulatory sequences to the 5' and 3' UTR regions to stabilize mRNA.
  • Modifying the polyA "tail" to stabilize mRNA and enhance protein translation.
  • Modification of nucleotides to reduce innate immune activation.
  • Isolation and/or purification techniques: RNase III treatment and fast protein liquid chromatography (FPLC) purification to reduce immune activation and improve translation.
  • Optimization of sequences and codons, selection of codons homologous to tRNA, and improvement of translation rates.
  • Regulation of target cells: co-delivery of translation initiation factors and other methods to optimize translation and immunogenicity.

mRNA Purification

In vitrotranscribed mRNA can produce a large number of impurities, including DNA templates, enzymes, NTP, salts, double-stranded (ds) RNA and truncated mRNA, which can affect the purity of mRNA production and negatively impact translation efficiency. creative Biogene utilizes a comprehensive set of tools and expertise to rapidly and self maximally improve mRNA quality and yield. Our skilled scientific team offers a variety of purification methods, including lithium chloride (LiCl) precipitation, oligonucleoside deoxythymidine (dT) magnetic particles, and chromatography.

Why Choose Us?

  • Rapid quality control.
  • High purity mRNA production without compromising yield.
  • Customizable manufacturing strategies according to customer requirements.

Creative Biogene's mRNA production and purification processes can be optimized and scaled up to meet your needs based on your product's specific characteristics and final requirements. We are committed to producing high quality, high purity mRNA for you. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

Reference:

  1. Wadhwa, A. et al. Opportunities and challenges in the delivery of mRNA-based vaccines. Pharmaceutics. 2020, 12(2): 102.
* For research use only. Not intended for any clinical use.
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