Acuitas: (noun) insight, perception, sharpness.

EXPERTISE AND CAPABILITIES

Acuitas Scientists Have Extensive Experience and Expertise in LNP Development and Characterization

ABOUT OUR TECHNOLOGY

The R&D areas we support are indicated below:

SYNTHETIC CHEMISTRY

  • Design and synthesis of novel lipids (e.g. cationic, pegylated)
  • Radiolabelled and stable-isotope lipids to support ADME studies
  • Synthetic process technology transfer to Contract Manufacturing Organization (CMO)

PRODUCT FORMULATION, SCALE-UP AND cGMP MANUFACTURE

  • Formulation development and optimization using scalable components and processes
  • Process characterization and optimization
  • Manufacturing process technical transfer to cGMP CMO

ANALYTICAL AND BIOPHYSICAL CHARACTERIZATION

  • Analytical methods development and transfer, including lipid and nucleic acid-specific analyses
  • Biophysical characterization including LNP size and size distribution encapsulation, surface charge and pKa, cryo-electron microscopy, 31P-NMR
  • Bioanalytical method development and analyses for LNP components

PRECLINICAL CHARACTERIZATION

  • Pharmacodynamic studies for protein replacement therapeutics
    • Reporter gene (e.g. luciferase, green fluorescent protein) 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
    • Clinical pathology/histopathology
    • Immune response characterization (e.g. complement, cytokines/chemokines)
  • Bioanalytical
    • Nucleic acid therapeutic
    • LNP components

PROGRAM AND ALLIANCE MANAGEMENT

  • Focuses on successful management of the program to meet partner objectives
    • Coordination and execution of Partner Work Plan
    • Monitoring budget, resources and timelines
  • Catalyses a strengthened partnership alliance to ensure excellent alignment on deliverables
    • Regular communication with partner project/program management team to ensure alignment
    • Management of objectives, agendas, material preparation, attendees and logistics for semi-annual face-to-face meetings