Analytical Support for mRNA Therapeutics
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
Content
RNA encapsulation efficiency
Determine mRNA/LNP encapsulation efficiency using fluorescence-based assay
RNA encapsulation efficiency
Determine mRNA/LNP encapsulation efficiency using fluorescence-based assay
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>
Preclinical/Clinical Testing (GLP or non-GLP)
Tests
Description
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
