Achieve Scalable Purity with Vernal’s mRNA and LNP Large-Scale Production
Attain the perfect balance of scalability and purity for your preclinical studies, including dose range finding and toxicology studies, with our
mRNA and LNP Large-Scale Production.
Designed to help advance lead candidates through preclinical development where larger quantities of high-quality material are required, our high-purity mRNA production and advanced LNP formulations ensure rapid and seamless scaling, effective mRNA delivery, and reliable results, whether you’re developing vaccines, advancing gene therapies, or discovering novel nanoparticle formulations.
Key Benefits
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Customized Solutions for mRNA and LNP Large-Scale Production in Research-Grade Applications
| Services | Custom mRNA manufacturing LNP Formulation |
| Delivery Time | 3 Weeks* |
| Research and Development Stage | Discovery Research IND-Enabling Studies Toxicology Studies Dose Range Finding Studies |
| Manufacturing Grades | Research Grade/Research Use Only |
| Production Location | Colchester, VT, USA |
| Size | 1 mg-25 grams |
| Length | 100-15,000 Nucleotides |
| NTPs | Modified Unmodified |
| Cap Type | Cap1 Methylated Cap Variants |
| Optional Add-ons | 5’ Cap Content poly(A) Tail Testing dsRNA Testing Residual pDNA Testing Residual Protein Testing Endotoxin Testing Identity Testing Additional Analytical Methods |
| Applications | Infectious Disease Vaccine Development Therapeutic Vaccine Development Gene Replacement Therapy In Vivo Gene Editing or Regulation Characterization of Novel Proprietary LNP Formulations Ex Vivo Cell Therapy |
| Use Cases | Standardized Source Lab Controls Large Animal Studies—Size or Quantity Dose Range Finding Studies |
| Upgrade to Pre-cGMP | Research Cell Bank Process Closure AOF Process Segregation Controls Test Method Qualification Primary Cell Bank cGMP-Representative Manufacturing Process |
*The time required for mRNA delivery is influenced by both the DNA template turnaround and the complexity of the construct. Time for gene synthesis is not included in this estimate.
Quality Assessment of
1-gram Batch
1-gram batch of mRNA from a pDNA template was manufactured using our standardized, platform pDNA and mRNA process technologies. The mRNA was purified using a single chromatography step. Based on capillary gel electrophoresis, the mRNA has exceptionally high product-related purity meaning that the total quantified mRNA will be full-length and active to produce protein. Further, the Cap analysis by LC-MS exceeds 98% Cap-1 meaning that the mRNA will be highly potent, possess low inflammatory responses, and have maximal 5’ end resistance to exonucleases. The poly(A) tail is within 5% of target length, which also enhances potency and provides maximal 3’ end resistance to exonucleases. We put this same process technology into your project to maximize potency and minimize inflammatory responses.
Figure 1. Product-Related Purity. Capillary gel electrophoresis depicts a single, sharp, symmetrical peak along with a stable baseline.
| Test/Quality Attribute | Method | Result |
|---|---|---|
| Capping Efficiency | LC-MS | > 98% (Cap-1) |
| poly(A) Tail; Length | Laser-induced Fluorescence-based Capillary Gel Electrophoresis | 124 nts |
| dsRNA | Dot Blot | 0.08% |
Start or Seamlessly Transfer Projects to Vernal
Begin your project with Vernal or seamlessly transfer your existing project to us and say
goodbye to constant delays in development, juggling multiple vendors, dealing with unclear
processes, and the persistent worry of sacrificing quality to meet deadlines.