Immunologix Laboratories is a science-based GLP and GCP compliant immunoassay laboratory focused solely on ligand binding based bioanalysis. We specialize in Immunogenicity, Neutralizing Antibody (cell based and ligand binding based), PK, and Clinical Biomarker assays in support of preclinical and clinical trials. The Translational Sciences Division provides enhanced experienced resources for technical strategy and implementation of bioanalytical and biomarker assays. Our customer-focused service model allows us to customize project execution for each client in a timely manner. The entire team has many years of CRO and industry experience in development, validation, and application of immunoassay-based methods.
- 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
- 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
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