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Vaccine R&D Solutions

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Vaccines play a crucial role in safeguarding human health and are a primary method for controlling infectious diseases. CD Formulation, with our advanced technology platform and extensive production experience, provides a comprehensive range of nucleic acid synthesis services to address the diverse needs of vaccines, from early research through clinical trials.

About mRNA Vaccines

Vaccines play a crucial role in protecting human health and are one of the primary methods for controlling infectious diseases. Currently, more than 20 high-risk diseases can be prevented through vaccination. mRNA vaccine is developed using mRNA technology. It functions by utilizing mRNA to instruct cells to synthesize viral proteins, which in turn stimulates the body's immune system to generate an immune response against the virus. This type of vaccine is straightforward, cost-effective, and quicker to develop and produce compared to traditional vaccine methods.

Highlights of mRNA Vaccine

mRNA vaccines effectively stimulate the body's immune system to produce a robust immune response against specific pathogens, encompassing both cellular and humoral immunity.
The mRNA technology is highly versatile and enables the rapid adaptation of vaccine design to target various viral variants or emerging pathogens.
mRNA vaccines do not utilize live viruses, which results in a lower risk of side effects. Additionally, they do not require virus culture and handling, thereby reducing safety concerns during production.
The production process of mRNA vaccines can be highly automated and scaled, which reduces production costs and time while facilitating mass distribution.

mRNA Vaccine Solutions Development

mRNA Vaccine Development

CD Formulation specializes in the production of high-quality synthetic mRNAs through a highly reproducible process that yields a final product with superior activity. The synthesis of mRNA is primarily conducted via in vitro methods, where RNA polymerase utilizes DNA as a template for the transcription of mRNA.

Steps	Descriptions
Capping at the 5' end	After capping, there is no free phosphate group at the 5' end of the mRNA, so it will not be recognized and degraded by alkaline phosphatase, and the methyl group on the two nucleotides behind the cap blocks the free 2'-hydroxyl group on the phosphodiester bond, so it won't be degraded by RNAase.
Optimization of 5'UTR/3'UTR	Replacement of a non-optimal codon with an optimal codon significantly improves mRNA stability, translation speed, and protein yield; codon bias is correlated with the amount of GC in the ORF, so adjusting the amount of GC in the ORF can change translation elongation.
Nucleotide modification	Chemical modification of nucleotides can effectively reduce the immunogenicity of mRNAs.
Design of 3'poly A tail	Removing poly A by polynucleotide phosphorylase can reduce the peptide elongation rate and the number of translation rounds. Adding poly A tail can reduce the U sequence and the immunogenicity of mRNA.

Characterization for mRNA

The mRNA feedstock generated from in vitro transcription undergoes a series of tests, including assessments of mRNA concentration and purity, sequence integrity, expressivity, and safety. CD Formulation's specialized technology platforms offer a variety of mRNA analytical tests to ensure that our customers receive high-purity, high-quality products.

Quality	Attribute	Method
Identity	mRNA sequence identity confirmation	PCR
Content	RNA concentration	Quantitative PCR (qPCR) Ultraviolet Spectroscopy (UV)
Integrity	5' capping efficiency	High-performance liquid chromatography (HPLC)
	3' poly(A) tail length	High-performance liquid chromatography (HPLC)
	Product related impurities - dsRNA	Enzyme-linked immunosorbent assay (ELISA)
	Product related impurities - percentage of fragment mRNA	High-performance liquid chromatography (HPLC)
	Process related impurities-residual DNA template	Quantitative PCR (qPCR)
	Process related impurities - residual T7 RNA polymerase content	Enzyme-linked immunosorbent assay (ELISA)
Safety	Bioburden	PCR

mRNA Delivery System Development

CD Formulation's development of an mRNA delivery system involves optimizing the physicochemical properties and design of carriers. This optimization ensures efficient encapsulation and delivery of the mRNA. The entire development process is rigorously evaluated and refined to guarantee the safety and efficacy of the system.

Fig.1 mRNA delivery system development. (CD Formulation)

Applications of mRNA Vaccines

Cancer

mRNA vaccines are emerging as a novel strategy in cancer therapy, capable of encoding tumor-specific antigens that activate the patient's immune system to target cancer cells. This personalized vaccine can be customized to the unique characteristics of the patient's tumor, thereby enhancing the immune response.

Viral Infectious Diseases

mRNA vaccines have demonstrated significant potential against various viral infectious diseases, including influenza, Zika virus, and human papillomavirus. Their ability to be rapidly synthesized and produced allows mRNA vaccines to respond swiftly to emerging viruses and offer effective immune protection.

Novel Coronavirus Infections

mRNA vaccines have played a crucial role in addressing infections caused by the novel coronavirus (SARS-CoV-2). They have been developed rapidly and successfully, and are widely used to prevent the spread of COVID-19. These vaccines provide essential support in the global fight against the pandemic by encoding viral spike proteins that elicit a robust immune response.

Publication Data

Technology: Production of mRNA vaccines by in vitro transcription technology

Journal: Frontiers in immunology

IF: 5.7

Published: 2020

Results:

COVID-19 Pandemics demonstrate the persistent threat of pandemics with high transmissibility caused by novel, previously undiscovered or mutated pathogens. Currently, vaccine development is too slow for use in controlling emerging pandemics. RNA-based vaccines may be suitable to meet this challenge. The use of RNA-based delivery mechanisms holds the promise of rapid vaccine development, clinical approval, and production. mRNA is very simple to transcribe in vitro, and thus has the potential for rapid, scalable, and low-cost production. RNA vaccines are theoretically safe and showed acceptable tolerability in the first clinical trials. Although the theoretical properties of RNA vaccines appear promising, their clinical efficacy is a key question regarding their suitability for use in response to emerging epidemics. The ongoing SARS-CoV-2 mRNA vaccine efficacy trials may answer this question.

Fig.2 mRNA and saRNA protein production in antigen presenting cells. (Sandbrink J B, et al., 2020)

CD Formulation specializes in the comprehensive development of mRNA vaccines, encompassing essential processes from in vitro synthesis of mRNA to transfection, protein expression assays, and preclinical immune evaluation. Contact us for high-quality raw materials and tailored solutions to ensure vaccine stability and efficacy.

References

Sandbrink J B, Shattock R J. RNA vaccines: a suitable platform for tackling emerging pandemics? FRONT IMMUNOL. 2020, 11: 608460.

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STEP 2

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STEP 3

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