mRNA HPLC Analysis Service

mRNA HPLC analysis is a critical process based on high-performance liquid chromatography (HPLC) technology, used to evaluate key quality attributes of mRNA, including length distribution, poly(A) tail length and heterogeneity, as well as impurities such as short transcripts and double-stranded RNA. By utilizing anion exchange or reversed-phase columns, mRNA HPLC analysis achieves high sensitivity and high-resolution separation and quantification, providing an accurate sample foundation for downstream mass spectrometry analysis. This process serves as a reliable tool for mRNA drug development and production, playing a central role in quality control.

 



Nakayama, H. et al. Anal Chem. 2023.

Figure 1. Strategy for Quality Control of mRNA Medicines

 

mRNA HPLC analysis is essential for ensuring the quality and safety of mRNA therapeutics, as impurities generated during production, such as short transcripts or double-stranded RNA, can impact the stability, purity, and efficacy of the final product. This analysis enables precise evaluation of the types and levels of these impurities, helping to optimize in vitro transcription (IVT) processes and improve purification strategies to meet strict regulatory standards. mRNA HPLC analysis also provides comprehensive information on batch-to-batch consistency, allowing manufacturers to quickly identify and resolve production issues, ultimately ensuring the delivery of high-quality mRNA therapeutics to patients.

 

Services at MtoZ Biolabs

MtoZ Biolabs offers comprehensive mRNA HPLC analysis service dedicated to helping clients address quality control challenges in mRNA drug development and production. We utilize advanced HPLC technology combined with various separation modes, such as anion exchange and reversed-phase chromatography, to provide comprehensive mRNA insights. Our mRNA HPLC analysis service covers all stages, from in vitro transcription (IVT) to the purification process, delivering high-sensitivity and high-resolution quality analysis support.

 

MtoZ Biolabs' mRNA HPLC analysis service is aimed at optimizing process development through precise detection and in-depth data interpretation, helping clients identify and resolve potential production issues. Our team of experienced scientists, equipped with state-of-the-art technology, ensures compliance with stringent regulatory requirements while guaranteeing product consistency and high-quality delivery. If you are interested in our mRNA HPLC analysis service, please feel free to contact us.

 

Service Advantages

1. Advanced Technology Platform

MtoZ Biolabs combines HPLC with mass spectrometry to deliver high-sensitivity, high-resolution mRNA HPLC analysis service, including length distribution, poly(A) tail heterogeneity, and impurity profiles, ensuring comprehensive and accurate detection.

 

2. Customized Solutions  

Addressing common challenges in mRNA analysis, such as the complexity of large RNA molecules and modification detection, mRNA HPLC analysis service in MtoZ Biolabs provides tailored analytical solutions, optimizing LC conditions to ensure precise characterization of structural integrity and impurities.

 

3. Extensive Expertise and Efficient Support  

With a highly experienced scientific team and state-of-the-art equipment, MtoZ Biolabs helps clients resolve quality control issues in mRNA production, supports process development and optimization, and accelerates the development and commercialization of mRNA-based therapeutics.

 

Case Study

Case 1: The study explores the use of liquid chromatography (LC) techniques to analyze the length and structural heterogeneity of mRNA poly(A) tails. These methods enable high-resolution separation and precise quantification, offering valuable insights into mRNA stability and translational efficiency. mRNA HPLC analysis service can also be applied to accurately characterize mRNA poly(A) tail length and heterogeneity, providing critical data to deepen the understanding of mRNA functionality and optimize its application in therapeutic development.

 



Gilar M, et al. Anal Chem. 2023.

Figure 2. IP RP LC Analysis of the Poly(A)tail Released from EPO mRNA and the FLuc-beta mRNA Sample

 

Case 2: This study investigates the use of anion exchange HPLC to monitor mRNA in vitro transcription reactions, highlighting the efficiency and accuracy of HPLC in analyzing mRNA product integrity, purity, and yield. This method enables real-time monitoring of transcription dynamics, optimization of process parameters, and ensures consistent product quality. mRNA HPLC analysis service provides precise and reproducible analytical results, supporting the efficient advancement of mRNA manufacturing process development and quality control.

 



Welbourne, EN. et al. Front Mol Biosci. 2024. 

Figure 3. Monitoring mRNA Purifications Using AEX HPLC

 

FAQ

Q1: How can HPLC analysis be optimized to accurately assess the quality and integrity of mRNA, including detection of impurities such as short transcripts and double-stranded RNA?

Answer: To optimize mRNA HPLC analysis for assessing mRNA quality and integrity, careful consideration must be given to column selection, buffer conditions, and detection sensitivity. Anion exchange or reversed-phase columns designed specifically for large biomolecules are highly suitable for separating full-length mRNA from impurities such as short transcripts and double-stranded RNA. Optimizing buffer ionic strength and pH ensures effective separation and sharp peak resolution, while maintaining a stable column temperature enhances experimental reproducibility. Coupling HPLC with UV or fluorescence detectors, or integrating it with mass spectrometry, allows precise identification and quantification of mRNA and its impurities. Additionally, rigorous sample preparation protocols are essential to prevent RNA degradation during analysis, ensuring the reliability and accuracy of results. These optimized strategies can be systematically applied in a mRNA HPLC analysis service to delivere precise, reproducible, and high-throughput evaluation of mRNA samples.

 

Deliverables

1. Comprehensive Experimental Details

2. Materials, Instruments, and Methods

3. Relevant Liquid Chromatography Parameters

4. The Detailed Information of mRNA HPLC Analysis

5. Raw Data