- 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
Preclinical Development (Tech Transfer, Scale Up, Analytical Methods, Manufacturing Processes)
Preclinical
Formulation Discovery and Optimization
Preclinical Development
(Scale Up, Methods, Processes)
Clinical Phase
I/II/III
Commercial
Fill and Finish
Scalable Manufacturing Process Development
Analytical Methods Development - Complete Analytical Panel
- 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