Services

Immunologix Laboratories provides GLP and GCP compliant ligand binding assay services of the highest caliber to the pharmaceutical and biotechnology industries. Our services include:

  • Customized development of ligand binding assays

    • Selection of best assay format based on client needs
    • Assessment and characterization of all critical reagents
    • Pre-validation testing of every method to ensure successful a validation
  • Cell based Neutralizing Immunogenicity assays

    • Selection of best cell based system for each biologic
    • Ligand binding based neutralizing assays may be recommended in lieu of cell based assays depending on client needs, cell based assay performance, and the properties of the biologic being tested
    • Cell based assays will include the establishment of master cell bank to ensure longevity and consistency
    • Pre-validation assessments are done to ensure the assay will meet all validation requirements
  • Validation of assays

    • All Bioanalytical PK and Immunogenicity assay validations are based on regulatory guidances and industry practices to ensure compliance with relevant regulatory agencies
    • Customized design of Biomarker ligand binding assay validation based on context of use and a fit for purpose mindset
  • Immunologix Laboratories - Facility