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

Preclinical
Formulation Discovery and Optimization
Preclinical Development
(Scale Up, Methods, Processes)
Simply Start Your Project
Clinical Phase
I/II/III
Commercial
Fill and Finish

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

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