mRNA-Based Vaccines and Therapeutics Drugs DMPK Services

For mRNA-based vaccines and therapeutics, as well as their delivery system, the difference in the action mechanism and molecular type lead to distinct evaluation objectives and requirements in their preclinical pharmacokinetic study. We can provide appropriate DMPK study design based on the characteristics of each product, accelerating the research and IND application of mRNA-based vaccines, therapeutics, and delivery systems.

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Overview
Study Models and Platforms
Strengths
Study Strategies and Assays
Instruments
Case study
FAQs
Related Resources
Related Services

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Overview

To facilitate the research and development of mRNA-based vaccines and therapeutics, WuXi AppTec DMPK has established an integrated bioanalytical platform. This platform includes qPCR, branched DNA (bDNA), ligand binding assays (LBA), liquid chromatography-mass spectrometry (LC-MS), and flow cytometry, enabling quantitative and semi-quantitative analysis of mRNA. We determine the pharmacokinetic study strategy based on the unique characteristics of each client’s products and provide appropriate study design, accelerating the research and IND application of mRNA-based vaccines, therapeutics, and delivery systems.

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Study Models and Platforms

RT-qPCR quantification analysis

We reference the consensus qPCR validation guidelines on the whitepaper published by the Global CRO Council in Bioanalysis (GCC) and generate our internal mRNA bioanalysis validation guidance. With rich experience in qPCR analysis, we can support fast screening in the development period and IND filing. We developed and validated the mRNA bioanalysis method in rat whole blood and solid tissue (such as liver) by using an mRNA mimic (EGFP mRNA). The standard curve and inter/intra accuracy and precision evaluation from the validation results are shown below.
In vivo Fluorescence imaging platform for rodent animals

In vivo Fluorescence imaging platform can mark targets through bioluminescence or fluorescence principles, realize real-time continuous dynamic monitoring of various biological processes in the body, reduce the number of experimental animals used, and reduce the impact of individual differences. It can support the biodistribution and tissue targeting study of delivery system or mRNA.
Biopsy technology for large animals

The ultrasound-guided liver biopsy technique in large animals can meet the needs for continuous multiple liver collections, supporting the research of liver-targeted mRNA drugs within large animals.
Radioisotope tracer and QWBA platform

The radioisotope tracer and QWBA platform facilitate the investigation of the biodistribution of LNP delivery systems in rodents and cynomolgus monkeys.

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Strengths

Committed to Your Program
Cross-Department Cooperation and High Efficiency
Extensive Experience and Customized Research Strategies
Comprehensive Capabilities with an Integrated Bioanalytical Platform

Study Strategies and Assays

mRNA products comprise two major categories: mRNA vaccines and therapeutics. mRNA vaccines activate the immune system by expressing antigens to achieve preventive or therapeutic purposes, with low dosage and relatively low administration frequency. mRNA therapeutics exert therapeutic effects by expressing functional proteins, while drug efficacy is related to protein expression levels and duration directly. Additionally, the delivery system is an integral component of mRNA products. In preclinical studies, it is necessary to combine the mechanism of action of products and develop appropriate study strategies for different components of the product, to characterize the pharmacokinetic profile comprehensively.

Items

Assays

mRNA Vaccines

Biodistribution

• Tissue distribution study of mRNA

mRNA Therapeutics

In Vivo PK

• Pharmacokinetic study of mRNA/translated proteins

• PK/ PD study of mRNA/translated proteins

• Immunogenicity study of translated proteins

Biodistribution

• Tissue distribution study of mRNA/translated proteins

Lipid Nanoparticle (LNP) Delivery Systems

In Vivo PK

• Plasma pharmacokinetic study of LNPs

• Immunogenicity of PEG lipids

Biodistribution

• Tissue distribution study of LNPs

In Vitro and In Vivo Metabolism

• Stability of novel lipids in plasma, liver microsomes,

and hepatocytes

• Metabolite identification of novel lipids in liver

microsomes and hepatocytes

• In vivo metabolite identification of novel lipids

Excretion

• Excretion study of LNPs

Drug Interactions

• Inhibition and induction effect on metabolic enzymes

by novel lipids

• Inhibition effect on transporters by novel lipids

Instruments

Case study

Background: For IND applications of mRNA-based vaccines and therapeutics, a robust and validated bioanalysis method for mRNA absolute quantification is required. Currently, there is no official guidance for mRNA bioanalysis validations. Here, we reference the consensus qPCR validation guidelines on the whitepaper published by the Global CRO Council in Bioanalysis (GCC) and generate our internal mRNA bioanalysis validation guidance. We developed and validated the mRNA bioanalysis method in rat whole blood and solid tissue (such as liver) by using an mRNA mimic (EGFP mRNA). The validated qPCR method will be suitable for FDA/NMPG/TGA IND application. The standard curve and inter/intra accuracy and precision evaluation from the validation results are shown below.

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FAQs

What is mRNA vaccine?

mRNA vaccines involve directly injecting modified mRNA encoding pathogen-specific antigens into the human body after certain processing steps, allowing the body’s protein synthesis system to produce the desired antigens. This type of vaccine does not involve live pathogens in the production or vaccination processes, which eliminates the risk of virus spread and infection. mRNA vaccines can also target the expression of specific antigens, avoiding the adverse effects that other components of pathogens can impose on the human body. Furthermore, it involves “infection” of the cells, which can trigger both humoral and cellular immunity. However, the application of this vaccine technology has a shorter development timeline compared to other vaccine technologies and thus requires extensive validation.
What is the difference between mRNA vaccines and mRNA-based therapeutics?

First, mRNA vaccines encode antigenic proteins and generally require only a low level of protein expression to exert their effects. The induction of antigenicity in the body reflects their efficacy. In contrast, mRNA therapeutic drugs generally require a high level of protein expression. And it is desirable to minimize the stimulating immunogenicity, as that may reduce the concentration of the therapeutic protein. Second, vaccines do not require tissue-specific delivery, but mRNA therapeutic drugs must be delivered to specific tissues for translation. Third, most vaccines are injected into muscles because muscle tissue has extensive blood flow and high levels of infiltrating immune cells. Whereas, mRNA therapeutic drugs are mostly administered systemically or topically to target tissues according to their therapeutic purpose. Overall, mRNA vaccine development technology has been well established, whereas the development of mRNA therapeutic drugs has faced several challenges, including improving protein expression levels, reducing immunogenicity, improving tissue targeting, exerting long-term effects, and improving long-term safety for repeated use.

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mRNA-Based Vaccines and Therapeutics Drugs DMPK Services

Overview

Study Models and Platforms

RT-qPCR quantification analysis

In vivo Fluorescence imaging platform for rodent animals

Biopsy technology for large animals

Radioisotope tracer and QWBA platform

Strengths

Study Strategies and Assays

Instruments

Case study

FAQs

Related Resources

What is mRNA Vaccines and Its Future?

Strategies for Preclinical PK Evaluation of mRNA-Based Therapeutics: mRNA Vaccines, mRNA Therapeutic Drugs, and Novel Excipients

Evaluation of mRNA Capping Efficiency by Liquid Chromatography Coupled to High Resolution and Accurate Mass Spectrometry

An Efficient Bioanalytical Method for mRNA Drug in Mouse Blood and Tissue Samples

Comparison of Branched DNA (B-DNA) and Polymerase Chain Reaction (RT-qPCR) Method Validation for the Quantification of mRNA Therapeutics in Plasma

mRNA-Based Vaccines and Therapeutics Shorten the Development Cycle with WuXi AppTec DMPK Services

What Can We Learn from the PK Profiles of FDA Approved mRNA Vaccines

Vaccine Development Driven by SARS-CoV-2: The Promising Prospect of mRNA Vaccines

FDA Approved mRNA Vaccines: Interpretation of Preclinical Pharmacokinetic (PK) Data

How to Conduct Preclinical Pharmacokinetic Evaluation of mRNA-Based Therapeutics?

What is mRNA Vaccines and Its Future?

Strategies for Preclinical PK Evaluation of mRNA-Based Therapeutics: mRNA Vaccines, mRNA Therapeutic Drugs, and Novel Excipients

Evaluation of mRNA Capping Efficiency by Liquid Chromatography Coupled to High Resolution and Accurate Mass Spectrometry

An Efficient Bioanalytical Method for mRNA Drug in Mouse Blood and Tissue Samples

Comparison of Branched DNA (B-DNA) and Polymerase Chain Reaction (RT-qPCR) Method Validation for the Quantification of mRNA Therapeutics in Plasma

mRNA-Based Vaccines and Therapeutics Shorten the Development Cycle with WuXi AppTec DMPK Services

Related Services

Stay Connected