A Novel Drug Delivery Vehicle

GenScript proudly offers lipid nanoparticle (LNP) formulation services for mRNA and circular RNA drug research and development service.

LNPs have been proven to be an effective drug delivery system for RNA therapeutics which can be easily degraded in vivo. The lipid layer can fuse with the cell membrane, allowing the encapsulated RNA to enter the cell and exert its therapeutic effect. They also protect therapeutic agents from degradation and improve their bioavailability

LNPs are used in various applications, such as delivering RNA-based therapeutics or small molecules.

Variety of ionizable lipid formulation with high encapsulation efficiency

Variety of ionizable lipid formulation with high encapsulation efficiency

Proven in vitro delivery & expression efficiency

Proven in vitro delivery & expression efficiency

Variety of ionizable lipid formulation with high encapsulation efficiency

Tested for in vivo expression
via both I.M. and I.V.

LNP Service Options

Characteristics

  • Ionizable lipid formulations
    (MC3-LNP / SM102-LNP/ ALC0315-LNP/ LP01-LNP)
  • Final concentration can be customized <0.4 mg/mL
  • Liquid, ships frozen on dry ice, one time freeze/thaw cycle

QC Testing

  • Encapsulation Efficiency: >80%
  • Size Distribution: POI ±20 nm
  • Polydispersity Index: <0.28
  • Zeta potential: ± 15 mV
  • pH: 7.4 ± 0.5
  • Endotoxin : <0.5 EU/ml 

Size/Scale Options

  • Load 20nt ~ 10kb mRNA
  • Load  1- 30 mg mRNA

Administration

  • Intramuscular (I.M.) for animal use only
  • Intravenous (I.V.) for animal use only
  • For in vitro studies

Manufacturing Workflow

Our integrated IVT RNA manufacturing workflow streamlines production from gene synthesis to LNP packaging.

Manufacturing Workflow

Quality Control and Specification

Item Test Method Specification RUO Standard QC RUO Upgrade QC
Appearance Visual Inspect Clear and free of foreign particles​
Final Concentration RiboGreen assay 0.05~ 0.4 mg/mL
Encapsulation Efficiency RiboGreen assay > 80%
Encapsulated RNA Integrity Bioanalyzer > 75%
Particle size Dynamic light scattering POI ±20 nm , 65 ~ 150 nm
Poly Dispersity Index Dynamic light scattering < 0.28
Zeta Potential Zetasizer by dynamic light scattering ± 15.0 mV
PH​ pH paper 7.4 ± 0.5​
Endotoxin​ Quantitative <0.5 EU/ml
Bioburden​ Direct inoculation No Growth after 48hrs

Case Studies

FAQs

What is an LNP?

Lipid nanoparticles (LNPs) are natural or synthetic molecules that can self-assemble into a spherical structure. LNPs are typically composed of lipid layer, which forms a shell around an inner compartment that can be used to deliver drugs or other therapeutic agents. LNPs have become increasingly popular as a drug delivery system due to their ability to protect therapeutic agents from degradation and improve their bioavailability. They can also be designed to target specific cells or tissues, allowing for more precise delivery of drugs. LNPs have been used in various applications, including the delivery of RNA-based therapeutics such as mRNA vaccines. The lipid layer of LNPs can fuse with the cell membrane, allowing the encapsulated RNA to enter the cell and exert its therapeutic effect. LNPs have also been investigated as a potential delivery system for other types of drugs, including small molecules and proteins.

mRNA LNP in vitro Cell Transfection - LNP transfection is as easy as 1, 2, 3

  • LNP can be added directly to cells incubated in complete media
  • Cells grown and transfected in complete media (DMEM +10% FBS) has higher expression than reduced serum medium
  • For eGFP expression and analysis on plate reader, we recommend using low fourescent background media such as Flourobrite® with 10% FBS, 1X GlutaMax® and 1X sodium pyruvate
  • Same protocol can be used for adherent and immune cell lines
mRNA LNP in vitro Cell Transfection - LNP transfection is as easy as 1, 2, 3

Resources

LNP Case Study Report
LNP Case Study Report

Case studies demonstrating encapsulation and delivery efficiency of GenScript’s new LNP formulations in cell models, and mouse models via both IM and IV.

Free Download

Additional mRNA Offerings

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with GenScript Lipid Nanoparticle Formulation

Get in Touch with GenScript IVT mRNA Production Services
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