The rigorous analysis of mRNA is critical to ensuring batch quality and consistency.
BASE has an on-site suite of analytical instruments supported by a quality control team with experience analysing hundreds of diverse mRNAs.
Our analytical services are available to support stability, characterisation and method development studies.
BASE scientists are leading the development of new methods to improve mRNA analysis.
We have partnered with Oxford Nanopore Technologies to develop single-molecule, nanopore sequencing test for mRNA vaccines and therapies.
This method will provide a comprehensive, streamlined analysis of mRNA quality features, including sequence identity, integrity, modified nucleotides and polyA tail.
Each batch of DNA template is tested prior to release to confirm identity, purity and quality.
| Quality Feature | Method |
| Sequence Identity | NGS, Sanger |
| DNA Concentration / Purity | UV Spectroscopy (A260/280) |
| Residual Host DNA | qPCR |
| Residual Host RNA | HPLC |
| Residual Protein | SDS-PAGE, ELISA |
| pH | USP <791> |
| Endotoxin | USP <85> |
| Bioburden | USP <61> |
| Sterility | USP <71> |
| Appearance | USP <1>, <790> |
| Residual Antibiotics | ELISA |
| Quality Feature | Method |
| mRNA Sequence Indentity | NGS, Sanger |
| mRNA Concentration / Purity | UV Spectroscopy (A260/280) |
| mRNA Integrity / Size | Capillary Electrophoresis, HPLC |
| 5’Cap Efficiency | Phosphotase Digestion |
| 3’PolyA Tail Length | NGS, Sanger |
| dsRNA | Immunoblot, ELISA |
| Residual DNA | qPCR |
| Endotoxin | USP <85> |
| Bioburden | USP <61> |
| Sterility | USP <71> |
| Appearance | USP <1>, <790> |
| pH | USP <791> |
All mRNA batches are rigorously tested to ensure identity, quality and purity. Each batch is accompanied with a Certificate of Analysis (CoA) reporting mRNA batch quality.
Our mRNA can be formulated within lipid nanoparticles (LNPs). Each batch is tested to ensure their quality and purity.
| Quality Feature | Method |
| mRNA Sequence Identity | NGS |
| mRNA Concentration / Purity | UV Spectroscopy (A260/280) |
| mRNA Integrity / Size | Capillary Electrophoresis, HPLC |
| Lipid Content / Identity | RP-HPLC |
| Particle Size / Uniformity | Dynamic Light Scattering |
| Zeta potential | Dynamic Light Scattering |
| mRNA Content/Encapsulation | Fluorescence (Ribogreen) |
| Endotoxin | USP <85> |
| Bioburden | USP <61> |
| Sterility | USP <71> |
| Appearance | USP <1>, <790> |
| pH | USP <791> |
| Residual solvents | USP <467> |
| Osmolality | USP <785> |
