Preclinical Development (Tech Transfer, Scale Up, Analytical Methods, Manufacturing Processes)

Scalable Manufacturing Process Development

Solvent and Ethanol Injection Microfluidics using NanoSizer FLOW Technology Small to Large Batch Scale Manufacturing of any type of lipid nanoparticles and several types of polymer nanoparticles
Thin-film Hydration and Extrusion using NanoSizer AUTO Extrusion Technology
Lyophilization and Freeze Drying for making dry content with removal process used to preserve perishable materials, to extend shelf life or make the material more convenient for transport.
Required Post Process: Complexing Nucleic Acids, Pegylation
Tangential Flow Filtration (TFF) for Ethanol Solvent Inline Technologies
Homogenization with Microfluidics Technologies for Micro- and Nano- Emulsions
Sonication for Small to Large Scale Liposome and Lipid Nanoparticles. Small to Large Batches
Freeze-thawed liposomes
Micro-emulsification
Dried reconstituted vesicles
Scale Up Processes
We have all processes that are needed to prepare your LNP therapeutics or vaccine samples including: Solvent and Ethanol Injection Microfluidics, Thin-Film Hydration, Pegylation and Complexing, Extrusion, Microfluidizer Homogenization, Lyophilization

Lipid Nanoparticle Encapsulated Cargo Size using Dynamic Light Scattering Techniques
Encapsulation efficiency (EE %) using multiple techniques
Surface Charge, Zeta Potential Method Development - USP Standards
UV-Vis for light absorption characterizations - USP Standards
Concentration Methods Using High-Performance Liquid Chromatography (HPLC) with UV-Vis, Evaporative Light Scattering Detector (ELSD) and Refractive Index, Fluorescence Detectors
pH Assay Using USP standards
Visual Appearance Using USP standards
Residual Solvent Using Gas Chromatography Flame-Ionization Detection (GC-FID) and Headspace Samplers
Content Purity Using High-Performance Liquid Chromatography (HPLC) with UV-Vis and Refractive Index, Fluorescence Detectors
Mass Spectroscopy: we use HPLC-MS for measurement of the specific molecule
Complete ICH Short and Long Term Stability Studies