The rapidly evolving mRNA therapeutics landscape demands rigorous quality control and precise characterization to ensure the safety and efficacy of next-generation treatments.
However, meeting stringent regulatory requirements and establishing robust analytical frameworks for both drug substances and drug products presents significant technical and compliance challenges.
This brochure outlines a comprehensive suite of analytical services aligned with the latest guidelines and standards from the United States Pharmacopeia (USP).
Download the brochure to explore:
- The latest testing and analysis approaches to support compliance with USP standards
- How high-precision techniques like LC-MS and IP-RP-UPLC deliver detailed characterization of structural integrity
- Comprehensive strategies to identify and quantify impurities
Unlock the Power of mRNA with
Aldevron’s Analytical Testing
Guidelines For mRNA Drug Substance and Drug Product
Manufacturing and Quality Control
Comprehensive Analytical Services
As the mRNA therapeutics market evolves, the demand for rigorous testing for characterization, stability, and
release of mRNA drug products is set to rise. Aldevron is dedicated to meeting these higher expectations
by providing advanced capabilities and solutions essential for client’s specifications. To support the growing
mRNA field, Aldevron offers a wide range of analytical services in accordance with the latest guidelines and
standards from the United States Pharmacopeia (USP), ensuring that your mRNA products meet the highest
standards of quality and safety.
Our Analytical Offerings
Sequence Verification: Confirm mRNA identity
with high precision and accuracy through comprehensive
nucleotide sequence analysis.
Quantification: Measure mRNA content reliably
using robust analytical methods.
Integrity Assessment: Evaluate mRNA structural
integrity, including the 5’ cap and 3’ poly(A) tail,
with state-of-the-art analytical capabilities.
Impurity Profile Characterization: Conduct
comprehensive detection and characterization of
product-related impurities (e.g., truncated RNA and
double-stranded RNA) and process-related impurities
(e.g., residual DNA template, enzymes, and solvents)
for mRNA synthesis and LNP encapsulation.
Functional Test: Measure the translational efficiency
of your mRNA in relevant cell-based assays.
Quality Assurance: Provides independent oversight
and audit functions to ensure compliance and
drive continuous improvement in quality systems.
Advanced Methods for mRNA Analysis
LC-MS: Detailed characterization of 5’ and 3’ end
structures, including cap structure and poly(A) tail
length distribution.
IP-RP-UPLC: Quantification of 3’ poly(A) tail and
5’ Cap-1 modifications.
RT-dPCR: Precise mRNA-specific content
measurement in multivalent products.
UPLC-CAD: Identification and quantification of
lipid components, including lipid impurities and
degradation products.
DLS: Assessment of lipid nanoparticle (LNP)
polydispersity, providing insights into particle size
distribution and formulation stability.
Partner with Aldevron
Join the industry leaders who trust Aldevron’s expertise in mRNA drug substance and product manufacturing
and quality control. Together, we can pave the way for the next generation of pharmaceutical innovations.
mRNA Drug Substance (DS) and Drug Product (DP) Assay Tests
- According to Draft USP Guidelines
Quality Attribute Method1, 2 mRNA
Product Type
Use2
Content
Individual and total lipid concentrations;
Lipid composition UPLC CAD; N:P ratio calculated DP R
RNA Concentration
UV spectroscopy (SoloVPE®) DS R, S
RT qPCR DS R, S
RT-dPCR (for multi-valent LNP products) DS, DP C, R, S
Total and free RNA concentration; %
encapsulation efficiency (EE)
Fluorescence-based (Ribogreen®);
% EE calculated DP R, S
Identity
Identity of lipids UPLC CAD DP R
RNA Sequence
RT-Sanger sequencing DS, DP R
RT-PCR (Fluorescence) DS, DP R
Impurity
% RNA aggregates and % RNA fragments
SEC-HPLC DS, DP C, R, S
IP-RP-HPLC DS, DP C, R, S
dsRNA ELISA DS R
Free nucleosides
RP-HPLC DS C, R, S
RP-LC-MS (coming soon) DS C
Residual DNA Template qPCR DS R
Residual process proteins NanoOrange™ DS R
Integrity
LNP size and polydispersity DLS DP R, S
RNA intactness Capillary electrophoresis DS, DP R, S
Potency Target protein expression Cell-based assay DS, DP C
Purity
3’ poly(A) % tailed dPCR DS C, R, S
3’ poly(A) length IP-RP-HPLC DS C, R, S
5’ capping efficiency
IP-RP-HPLC DS R
RP-LC-MS DS, DP C
mRNA purity (coming soon) IP-RP-HPLC DS, DP C, R, S
1. In addition to USP methods not shown for endotoxin, bioburden, sterility, appearance, residual solvents, subvisible particles, osmolality,
pH, extractable volume, and container closure integrity
2. Definitions: Characterization (C), Release (R), and Stability (S); N:P ratio – ionizable lipid nitrogen:oligonucleotide phosphate molar ratio;
RT-qPCR – Quantitative reverse-transcription PCR; RT-dPCR – Reverse-transcription digital PCR; EE – Encapsulation efficiency;
UPLC CAD – ultra high-performance liquid chromatography with charged aerosol detector; RP-HPLC-CAD – Reversed-phase high-performance
liquid chromatography with charged aerosol detector; SEC-HPLC – Size exclusion-high-performance liquid chromatography;
IP-RP-HPLC – Ion pair reversed-phase high-performance liquid chromatography; ELISA - Enzyme-linked immunosorbent assay; RPLC-
MS – Reverse-phase liquid chromatography mass spectroscopy; DLS – Dynamic light scattering
Contact a mRNA specialist today!
+1 (701) 297-9256 • Toll-free (U.S. and Canada): +1 (877) 787-3362
Visit: aldevron.com/custom-manufacturing/rna
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