Lipid Nanoparticles For mRNA Delivery

Seattle Genova’s LipoX^TM platform has demonstrated outstanding performance for small and large-scale production of lipid nanoparticles. Our platform is designed and optimized to meet customer's specifications and documentation requirements. 

Messenger RNA (mRNA) has emerged as a new category of therapeutic agent to prevent and treat various diseases. To function in vivo, mRNA requires safe, effective and stable delivery systems that protect the nucleic acid from degradation and that allow cellular uptake and mRNA release. Lipid nanoparticles have successfully entered the clinic for the delivery of mRNA. 

LNPs are comprised of ionisable lipids, structural lipids, cholesterol, and PEG-grafted lipids, which each serve a purpose in the particle structure. The key component is the ionisable lipid, which can hold a positive charge at lowered pH, binding to the negatively charged phosphate backbone of nucleic acid cargo to form an active rich core protected by a lipid exterior. These can be tailored for different therapeutic targets and are essential to the function and efficacy of the LNP.

LipoX^TM platform offers many advantages including:

• High nucleic acid encapsulation efficiency and potent transfection

• Improved penetration into tissues to deliver therapeutics

• Low cytotoxicity and immunogenicity

Synthesis Service

• Formulation design

Customize liposomes design based on our clients’ demand by varying lipid compositions, vesicle sizes, surface charges, etc.

• Payload encapsulation 

Customize protocols to encapsulate mRNA into lipid nanoparticle with high encapsulation efficiency.

Analysis and characterization

• Critical LNP quality studies

Average size, polydispersity and detailed size distributions, particle concentration, size-based nucleic acid (NA) payload distribution, stability under a variety of stressors. 

• mRNA Impurity analysis

LC-MS analysis of RNase H cleaved 5’-end of target mRNA provides the required sensitivity and accuracy to determine capping efficiency. DNAPac RP reversed phase (RP) column is specifically designed for separation of oligonucleotides and DNA/RNA fragments. Operating with mobile phases compatible with direct mass spectrometry, analysis can be carried out using both LC-UV and/or LC-MS approaches.

• mRNA Identity Analysis

Run comprehensive analysis assays for liposomes before and after encapsulation, which includes visual appearance, size distribution, stability, entrapment efficiency, encapsulation efficiency analysis, in vitro release profile analysis, release rate, etc.

• Cell study 

In vitro transfection and expression test service.