LNP Formulation for targeted drug delivery
We offer you a bespoke LNP formulation development and production service, tailored to deliver your drug substance to your target organ or tissue with superior preclinical efficacy compared to currently available formulations.
Our service is designed to support discovery and early pre-clinical development projects, and provides you access to:
- Proprietary lipids
- Innovative, differentiated formulations
- Targeted delivery and tailored biodistribution
Contact us to discuss your LNP formulation needs
Our LNP formulation development service
The development of lipid-based delivery systems (LNPs and liposomes) is a complex process, with many factors to consider in the design and production of a delivery system that provides efficacy, targeted delivery, manufacturability and long-term stability.
Our expert team can structure a project to meet your delivery requirements with a service encompassing:
- Design of experiments to determine optimal lipid composition and molar ratios between lipids, providing guidance on lipid selection and assessment of manufacturability
- Small scale manufacturing of LNPs and liposome delivery systems encapsulating/complexing RNA-based drugs (mRNA, miRNA, siRNA) to support discovery and early pre-clinical development activities
- Formulation buffer screening for optimal pH and particle size, screening of cryoprotectants for longer term storage and stability, and selection of optimal manufacturing process
- Scale-up of LNP-RNA formulations using various mixing techniques to support pre-clinical and toxicology studies
- Analytical methods development coupled to manufacturing process development activities
- Custom-made lipid-based particles upon customer request based on route of administration/indication
- Manufacturability assessment studies prior to decisions on CMC development of drug product
Our LNP manufacturing process
Our manufacturing process uses various mRNA and lipid mixing technologies, including microfluidics and impingement skid mixing, followed by downstream processing by dialysis/tangential flow filtration (TFF) for buffer exchange, solvent removal and concentration by TFF, and finally sterile filtration.
Our QC & Analytics process
We provide phase-appropriate analytical development in parallel with manufacturing process development.
Typically, we apply the following tests to LNP formulations at the discovery and early pre-clinical stages:
| Test | Method |
|---|---|
|
Visual appearance |
Visual inspection |
|
pH |
Potentiometric pH determination |
|
Osmolality |
Freezing point depression |
|
Zeta-potential |
Electrophoretic light scattering |
|
Particle size |
Dynamic light scattering |
|
Polydispersity index |
Dynamic light scattering |
|
mRNA content |
Fluorometric assay |
|
mRNA encapsulation efficiency |
Fluorometric assay |
|
Lipid identity and content |
RP-HPLC-CAD |
|
Bacterial endotoxin |
Ph. Eur. 2.6.14 |
For GLP Tox and clinical batches we apply the following additional tests:
| Test | Method |
|---|---|
|
mRNA Purity & Integrity |
Capillary gel electrophoresis (CGE) |
|
Residual solvent (ethanol) |
Ph. Eur. 5.4./2.4.24 |
|
Subvisible particles |
Ph. Eur. 2.9.19 |
|
Sterility |
Ph. Eur. 2.6.1 |
|
Extractable volume |
Ph. Eur. 2.9.17 |
Take advantage of our years of expertise, proprietary lipids, and innovative, differentiated formulations for delivering your RNA-based drugs or vaccines.
For more information on our LNP formulation service please contact us at hello@ethernamanufacturing.com.