MEASURE QUALITY ATTRIBUTES FASTER

mRNA and LNP Analytical Services

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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.

Key Benefits

Comprehensive Quality Insight

Vernal’s Analytical Services will deliver deep insights into the CQAs of your mRNA and LNP formulations, ensuring reliable results—leading to faster and confident decision-making.

Accelerated Development

Whether using our standardized or tailored analytical methods, we can accelerate your mRNA program—enabling seamless progress through each development stage.

Adaptable Methods

We can swiftly adapt our qualification-ready methods to your drug discovery and development program, ensuring consistency and comparability across all products and lifecycle stages—reducing the risk of delays.

Enhanced Risk Management

Our mRNA and LNP analytical experts will help you put a strong analytical strategy in place—preventing development delays and minimizing costly setbacks.

Access Analytical Services Details

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Next Steps: Your Request Made Easy

Let us know which mRNA and LNP Analytical Services you’re interested in.

Confirm Details

We’ll follow up to confirm the details, scope, and pricing for your samples. For most services, our methods are standardized, but for specific needs like Cap Characterization or Lipid Composition, we’ll adapt our methods to your samples.

Ship Samples

Send us your samples for testing, and we’ll handle the rest!

Standard and Custom Analytical Methods Crafted to Measure CQAs Faster

Master Cell Bank Material

CQAAnalytical Method
Viability (Bacterial Cell Count)*Plating with Serial Dilution
Cell Morphology*Microscopic Visualization
Host Strain PurityBacteriophage Testing (Lytic and Lysogenic)
Microbial Cell Purity Test (Fungal and Bacterial Impurities)
Strain IDAPI 20E (Phenotype)
16s rRNA Sequencing
RAPD
Plasmid IDRestriction Mapping
Sanger Sequencing
Retention of Selectable Marker*Replica Plating on Selective Media
Retention of Recombinant ConstructdPCR

Plasmid Material

CQAAnalytical Method
Appearance*Visual Inspection
pH*Potentiometry (<USP 791>)
Bacterial EndotoxinKinetic Chromogenic LAL [Endosafe]
Bioburden*Enumeration 
Identity (Size)Restriction Mapping AGE
Identity (Sequence)Sanger Sequencing
NGS
Content*UV/Vis Spectroscopy (A260)
PurityUV/Vis Spectroscopy (A260/A280)
Plasmid Topology*CGE
Residual Total Protein Micro BCA
Residual Host Cell ProteinELISA
Residual Host Cell RNAHPLC
Residual Host Cell gDNAqPCR
Residual KanamycinELISA

mRNA Material

CQAAnalytical Method
Appearance*Visual Inspection
pH*Potentiometry (<USP 791>)
Osmolality*Freezing Point Depression
Bacterial EndotoxinKinetic 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

CQAAnalytical 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 Facility

Consolidating all research and manufacturing processes within a single CDMO at one location simplifies project life-cycle management, ensuring quality at every stage.

mRNA and LNP Analytical Services Demonstrated

Poster: Methods for mRNA poly(A) Sizing Using RNase Digestion & Capillary Gel Electrophoresis, & Nanopore-based Sequencing | Vernal Biosciences
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.

Ready to measure quality attributes faster?

Unlock your mRNA and LNP program’s potential with our fast, cutting-edge analytical services. At Vernal Biosciences, we help you swiftly assess quality attributes, keeping you on the fast track to success. Don’t let delays hold you back—contact us today to get started!