Acuitas: noun, insight, perception, sharpness.

Expertise and Capabilities : Acuitas scientists have extensive experience and expertise in LNP development and characterization

Acuitas scientists have extensive experience and expertise in the development and characterization of LNP delivery systems for nucleic acid therapeutics. The R&D areas we support are indicated below:

Synthetic chemistry
  • Design and synthesis of novel cationic and PEG-lipids
  • Radiolabeled and stable-isotope lipids to support ADME studies
  • Technology transfer to CMO.
Product formulation, scale-up and cGMP manufacture
  • Formulation development and optimization using scalable components and processes
  • Process characterization
  • Technical transfer to CMO (preferred partner with Northern Lipids Inc for cGMP manufacture)
Analytical and biophysical characterization
  • Analytical methods development and transfer
  • Biophysical characterization including LNP size and size distribution, surface charge and pKa, cryo-electron microscopy, 31P-NMR, etc.
Preclinical characterization
  • Pharmacodynamic studies for protein replacement therapeutics
    • Reporter gene (luciferase, GFP, etc) expression in vivo by fluorescent/luminescent live imaging
    • Reporter tissue/cell gene expression ex vivo by flow cytometry, fluorescence microscopy, or fluorescence/luminescence spectroscopy
    • Transgene expression by immunohistochemistry/ immunocytochemistry
  • Safety/Tolerability studies
    • CBC/Clin Chem/Histopathology
    • Immune characterization
  • PK/ADME
    • Nucleic acid therapeutic and LNP components
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