At Seattle Genova, we have a broad range of experience in supplying clients with mRNA products at the appropriate quality level for each program stage. Our proprietary mRNA synthesis technology achieves highly efficient and economical co-transcriptional capping, and we offer numerous post-transcriptional modifications, including Dnase and phosphatase treatments, enzymatic capping, and polyadenylation. Additionally, you can select from a variety of purification options, including silica gel purification, liquid chromatography isolation, and high-performance liquid chromatography.
The messenger RNA (mRNA) technology has got ample attention after the achievement of the two very beneficial mRNA vaccines during the current pandemic of COVID-19. mRNA vaccine has been stimulated to the core stage of the pharmaceutical industry, and the rapid growth of mRNA technology has exceeded expectations.
Beyond COVID-19, the mRNA vaccine has been tested for several infectious diseases and undergoing clinical trials. Due to the proficiency of constant mutation, viral infections demand abrupt responses and immediate generation, and therefore mRNA-based technology gives the best answers to sudden outbreaks.
mRNA vaccines against infectious disorders could be formulated as prophylactic or therapeutic. mRNA vaccines expressing antigens of infectious pathogens induce both powerful and potent T cell and humoral immune responses. The production method to generate mRNA vaccines is cell-free, simple and rapid if compared to the production of the whole microbe, live attenuated and subunit vaccines. This fast and simple manufacturing procedure makes mRNA a promising bio-product that can potentially fill the gap between emerging infectious disorders and the desperate need for productive vaccines.
Generating RNA at a big scale to satisfy commercialization is the first step toward giving rise to mRNA vaccines. Currently, all components needed for mRNA generation are available at the GMP grade; however, some components are supplied at a limited scale.
◆ Influenza mRNA vaccines hold enormous promises being an egg-free platform and directing to the generation of antigens with high fidelity in mammalian cells.
◆ mRNA has also been utilized in the veterinary field to prevent animal infectious diseases. Pulido et al. indicated that immunization with in vitro transcribed mRNA induced protection against foot and mouse disease virus in mice.
◆ Saxena and colleagues indicated that a self-amplifying mRNA vaccine encoding rabies virus glycoprotein induced an immune response and protected mice and could potentially be utilized to prevent rabies in canine.
Step 1. Plasmid Manufacturing
◆ mRNA synthesis begins with plasmid design and production.
◆ Plasmids are generated in bacterial cultures, then harvested and purified.
Step 2. In-vitro transcription (IVT)
◆ In vitro transcription is a method that facilitates for template-directed synthesis of RNA molecules of any sequence from short oligonucleotides to those of various kilobases in μg to mg quantities.
◆ It is based on the engineering of a template that contains a bacteriophage promoter sequence (e.g. from the T7 coliphage) upstream of the sequence of interest fulfilled by transcription utilizing the corresponding RNA polymerase.
Step 3. mRNA purification
◆ After certain manufacturing steps it is significant to purify the mRNA.
◆ mRNA purification eliminates enzymes, remaining nucleotides, plasmid DNA, and defective mRNA. New emerging technologies like Fibro chromatography, currently accessible for mAb purification, are in development for molecules such as DNA plasmids and mRNA.
Step 4. mRNA encapsulation and polishing
◆ The purified mRNA-based therapeutic is formulated in lipid nanoparticles (LNPs) as a drug delivery vehicle.
◆ Core chromatography can be used to further eliminate impurities.
Step 5. QC release and stability testing
Relying on your final mRNA application and clinical stage, the quality control testing requirements may vary.
◆ RNA content by UV-Vis
◆ Purity by IRRP HPLC
◆ Residual DNA by RT-qPCR
◆ Residual protein by MS
◆ Potency by cell-free translation
◆ Endotoxin and residuals measurements
◆ High quality products and services at competitive prices
◆ Custom tailored assistance to meet specific application or program needs
◆ Vast variety of modification, treatment, and purification options
◆ Accessible custom synthesis up to gram scales of mRNA and long RNA (multiple kilobases)
◆ In-house plasmid manufacturing optimized for therapeutic mRNA generation
◆ We provide high throughput evaluations along with faster results.
◆ we provide many different mRNA formulation services to meet your various end-point in vaccine delivery. These formulations come with specific functionality to improve the efficiency of vaccines in the physiological environment.
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2.Wolff J A, Malone R W, Williams P, Chong W, Acsadi G, Jani A, Felgner P L. Direct gene transfer into mouse muscle in vivo. Science. 1990;247:1465–1468.
3.Pardi N, Hogan M J, Porter F W, Weissman D. mRNA vaccines—A new era in vaccinology. Nat. Rev. Drug Discov. 2018;17:261–279.
4.Weng Y H, Li C H, Yang T R, Hu B, Zhang M J, Guo S, Xiao H H, Liang X J, Huang Y Y. The challenge and prospect of mRNA therapeutics landscape. Biotechnol. Adv. 2020;40:107534.
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