Accelerate Your Drug Discovery and Development with mRNA and LNP Analytical Services
Rapidly and confidently measure critical quality attributes (CQAs) across all stages of drug development—from discovery to clinical trials—with our mRNA and LNP Analytical Services. To meet the unique demands of mRNA drug discovery and development, Vernal provides both standardized and tailored analytical methods.
Whether you’re advancing vaccines, gene therapies, or innovative formulations, we will generate the insights you need for a deeper understanding and informed decision-making, enhancing risk management and preventing costly delays in your development timeline. Ultimately, we help you translate your results faster into safer, more effective mRNA medicines, profoundly improving the lives of patients in need.
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Standard and Custom Analytical Methods Crafted to Measure CQAs Faster
Master Cell Bank Material
| CQA | Analytical Method |
|---|---|
| Viability (Bacterial Cell Count)* | Plating with Serial Dilution |
| Cell Morphology* | Microscopic Visualization |
| Host Strain Purity | Bacteriophage Testing (Lytic and Lysogenic) Microbial Cell Purity Test (Fungal and Bacterial Impurities) |
| Strain ID | API 20E (Phenotype) 16s rRNA Sequencing RAPD |
| Plasmid ID | Restriction Mapping Sanger Sequencing |
| Retention of Selectable Marker* | Replica Plating on Selective Media |
| Retention of Recombinant Construct | dPCR |
Plasmid Material
| CQA | Analytical Method |
|---|---|
| Appearance* | Visual Inspection |
| pH* | Potentiometry (<USP 791>) |
| Bacterial Endotoxin | Kinetic Chromogenic LAL [Endosafe] |
| Bioburden* | Enumeration |
| Identity (Size) | Restriction Mapping AGE |
| Identity (Sequence) | Sanger Sequencing NGS |
| Content* | UV/Vis Spectroscopy (A260) |
| Purity | UV/Vis Spectroscopy (A260/A280) |
| Plasmid Topology* | CGE |
| Residual Total Protein | Micro BCA |
| Residual Host Cell Protein | ELISA |
| Residual Host Cell RNA | HPLC |
| Residual Host Cell gDNA | qPCR |
| Residual Kanamycin | ELISA |
mRNA Material
| CQA | Analytical Method |
|---|---|
| Appearance* | Visual Inspection |
| pH* | Potentiometry (<USP 791>) |
| Osmolality* | Freezing Point Depression |
| Bacterial Endotoxin | Kinetic Chromogenic LAL [Endosafe] |
| Bioburden* | Enumeration |
| Identity (Sequence) | Sanger Sequencing (RT), NGS, or RT-dPCR |
| Concentration* | UV/Vis Spectroscopy (A260) or Ribogreen |
| dsRNA* | Dot Blot or ELISA |
| %Capped (Cap(1))* | LC-MS |
| 3’ Poly(A) Tail Length* | CGE |
| mRNA Integrity* | CGE |
| Residual Total Protein | Micro BCA |
| Residual DNA Template | qPCR or dPCR |
| Residual Free NTPs | HPLC |
| Residual Solvents | GC |
| Potency | Cell-Based Assay |
mRNA-LNP Material
| CQA | Analytical Method |
|---|---|
| Subvisible Particulate Matter* | Light Obscuration or Microscopic Examination |
| Appearance* | Visual Inspection (USP <790>) |
| Container Content | Extractable Volume/Mass |
| Container Closure Integrity* | Laser Headspace or Vacuum Expansion |
| Sterility* | USP <71> |
| Osmolality* | Freezing Point Depression |
| pH* | Potentiometry (<USP 791>) |
| Bacterial Endotoxin | Kinetic Chromogenic LAL [Endosafe] |
| Elemental Impurities* | ICP-MS |
| Residual Solvents | GC |
| LNP Size* | DLS |
| LNP Polydispersity* | DLS |
| LNP Surface Charge | Zeta Potential |
| LNP mRNA Identity* | Deformulation with Sanger Sequencing (RT) or RT-dPCR |
| Total RNA Content* | Ribogreen |
| Encapsulation Efficiency* | Ribogreen |
| Lipid Content* | HPLC-CAD |
| RNA Integrity* | Deformulation with CGE |
| Uniformity of Dosage Units | USP <905> |
| Potency | Cell-Based Assay |
*Test recommended as part of stability studies.
mRNA and LNP Analytical Services Demonstrated
Scientific Poster: Methods for mRNA poly(A) Sizing Using RNase Digestion & Capillary Gel Electrophoresis, & Nanopore-based Sequencing
Poster Abstract: The poly(A) tail region of an mRNA functions to stabilize the mRNA and enable translation of the protein. Due to its biological importance of an mRNA’s poly(A) tail, the length of the poly(A) tail is typically evaluated as a CQA for manufactured mRNA medicines. The method described here was developed to evaluate the length of mRNA poly(A) tails via a low-cost, high-throughput three step method. The mRNA samples for this method are prepared using RNase enzymes that digest the phosphodiester bonds that are 3’ to any base that is not an adenosine, leaving intact only the poly(A) tails. The samples are then purified to remove the RNases, individual nucleotides, and short runs of adenosines that are not part of the poly(A) tail. The poly(A) tail fragments are analyzed using fluorescence-based capillary gel electrophoresis (CGE) with a ssRNA poly(A) reference ladder to determine the size of the poly(A) fragments in the sample. The CGE results of the poly(A) fragments are confirmed using direct sequencing of the intact mRNA by the Oxford Nanopore Technologies (ONT) minION.