Case Studies Archive - Bioanalytical Lab & Top CRO for Large Molecule Bioanalysis

Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization

When approached with an ADA assay rescue project that had failed at two prior CROs, the BioAgilytix team knew scientific ingenuity would be needed. See how we applied a novel approach to overcome target interference challenges on a tight deadline, and got the study back on track. Read More

Creating Neutralizing Antibody Assays for the Identification of Antibodies Against Adeno-Associated Virus for Gene Therapy

A case study on the development of a cell-based assay for the detection of neutralizing antibodies to determine patient eligibility to enroll in clinical trials for an AAV gene therapy. Read More

Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods

In this study, BioAgilytix had to assess the immunogenicity of the PEGlayted therapeutic with an approach that could maximize drug tolerance while maintaining high sensitivity. Read More

Use of MSD-ECL in Support of Multiplex Biomarker Study

A top-five pharmaceutical company needed several angiogenesis biomarkers analyzed to support multiple Phase I clinical oncology studies. Read More

PK Assay for Therapeutic Antibody Quantification in Sodium Heparin Plasma

While conducting the pre-validation stage of a pharmacokinetic assay study, a sponsor asked BioAgilytix to develop a method for analyzing a specific therapeutic antibody when the results generated by another lab were not consistent with what was expected. Read More

Case Studies

Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization

Creating Neutralizing Antibody Assays for the Identification of Antibodies Against Adeno-Associated Virus for Gene Therapy

Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods

Use of MSD-ECL in Support of Multiplex Biomarker Study

PK Assay for Therapeutic Antibody Quantification in Sodium Heparin Plasma

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