Assay development with ELISA, colorimetric, fluorescence, chemiluminescence and MSD electrochemiluminescence (ECL)detections
Assay validation under GLP regulations for PK and Immunogenicity assessment
Sample analysis of proprietary test article concentration or anti-drug antibody (ADA) in biological matrices.
Support preclinical and clinical biological drug development programs as well as monoclonal antibody screening and discovery
Workshop report, “Quantitative Bioanalytical Method Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays,” February 2007
Biologics by LC-MS/MS
QPS has been working on polypeptides and biologics using LC-MS/MS since 2000.
The brute force approach is a combination of protein precipitation, SPE, LLE to extract, clean-up, and concentrate a standard LC-MS/MS methodology. The more elegant approach is immunoaffinity chromatography and LC-MS/MS. This methodology is essentially using an immunoaffinity column to trap the biologic, wash and back-flush onto a reverse-phase trapping column, wash and then back-flush onto an analytical column for LC-MS/MS. The decision on what methodology to use depends on the biologics. Both methodologies are non-trivial and highly experienced bioanalytical chemists are needed.