Analytical Support for mRNA Therapeutics

Expert analysis of mRNA identity, purity, and stability – trusted by leading COVID-19 vaccine developers

Comprehensive support for raw materials, drug substance, and product release to ensure mRNA therapeutic quality

mRNA therapeutics harness the body’s own cellular machinery to produce therapeutic proteins, offering a rapid, flexible, and highly targeted approach to treating a wide range of diseases. From vaccines to protein replacement therapies, mRNA technology enables transient, non-integrating expression with reduced risk.

Are You Prepared?

To meet regulatory expectations and ensure the safety of mRNA therapeutics, developers must conduct thorough analytical testing across the product lifecycle. Agencies require detailed assessments of identity, purity, integrity, and impurities like residual DNA or dsRNA. Robust characterization and validated assays are key to mitigating risk and enabling regulatory success.

Comprehensive mRNA Release Testing

CGMP-Compliant Assays: Confirm mRNA identity, integrity, purity, and potency.
Advanced Quantification Methods: RT-qPCR, ddPCR, and UV-based assays for RNA concentration, ratio, and encapsulation efficiency.
Impurity Detection: Sensitive detection of dsRNA, residual DNA, and T7 polymerase using ELISA, gels, and qPCR.
Potency and Safety Assays: Custom cell-based potency assays and USP-compliant tests for sterility, endotoxin, and bioburden

Preclinical & Clinical Bioanalysis

GLP/non-GLP Assays: PK, PD, and biodistribution studies using validated RNA detection assays.
Immunogenicity & Immune Response: ADA testing, cytokine release, and immune profiling with ELISA, MSD, and flow cytometry.

Our Customers Say…

From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…

Project Manager, Belgium

Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.

Program Manager, California

It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.

Senior Scientist, Singapore