Analytical Support for mRNA Therapeutics

Thorough analytical testing is essential to verify the identity, purity, and stability of mRNA vaccines and therapeutics. Leveraging our extensive experience supporting leading mRNA COVID-19 vaccine manufacturers with raw material, drug substance, and drug product release, Avance Biosciences is prepared to assist you in ensuring the quality of your mRNA therapeutics.

mRNA DS/DP Testing (CGMP)

Critical Quality Attributes

Assay

Description

Identity

mRNA sequence identity confirmation

Confirm the sequence of mRNA by Sanger Sequencing or NGS or RT-qPCR

Identity of RNA mixture

Confirm the presence of multi-valent mRNA drug substance or product using RT-qPCR or ddPCR

Content

RNA encapsulation efficiency

Determine mRNA/LNP encapsulation efficiency using fluorescence-based assay

RNA concentration

Quantify mRNA using UV Spectroscopy, RT-qPCR, or ddPCR

RNA encapsulation efficiency

Determine mRNA/LNP encapsulation efficiency using fluorescence-based assay

RNA Ratio Determination

Confirm the ratio of the mRNAs in multi-valent mRNA vaccine drug substance or product using RT-qPCR or ddPCR

Integrity

RNA Size and Integrity

Determine mRNA intactness using CE or Agarose gel electrophoresis

Purity

Process related impurities-residual DNA template

qPCR-based assay to detect potential DNA contamination

Product related impurities – dsRNA

Detect various dsRNAs using immunoblotting, native and denaturing gel electrophoresis, or ELISA

Purity

Process related impurities-residual DNA template

qPCR-based assay to detect potential DNA contamination

Process related impurities -residual T7 RNA polymerase content

ELISA-based assay to detect potential DNA contamination

Potency

Expression of target protein

Develop and validate a custom cell-based assay to determine potency

Safety

Bioburden

USP <61>

Endotoxin

USP <85>

Safety

Bioburden

USP <61>

Sterility

USP <71>

Other

USP <791>

Appearance

USP <790>

Other

USP <791>

Osmolality

USP <785>

Preclinical/Clinical Testing (GLP or non-GLP)

Tests

Description

mRNA/LNP
Biodistribution Study

Develop and validate RT-qPCR and/or ddPCR assays and test tissues/blood from various animal models under GLP or non-GLP

Pharmacokinetics
(PK) Study

Develop and validate RT-qPCR and/or ddPCR assays and test human bodily fluids for mRNA expression

Pharmacodynamics
(PD) Study

Develop and validate custom assays to measure biomarker levels or protein activity using flow cytometry, Western blot, ELISA, or MSD

Anti-Drug Antibody
(ADA) Analysis

Develop and validate ADA assays by employing multi-tiered testing approach using ELISA, MSD, or Flow Cytometry

Cytokine Release and
Immune Profiling

Develop and validate custom assays to assess the immune response to the mRNA therapeutic using ELISA, MSD, or Flow Cytometry

Have Questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.