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Validated Assays

Services > Bioanalysis > Biologics

Biologics

Biologics by Ligand Binding Assay (LBA)

QPS is at the forefront of a wide range of ligand binding assays for a variety of discovery research and drug development studies. Our scientists have extensive experience in the development and validation, under GLP guidelines, of immunoassays and various technology platforms. Our in-depth technical expertise enables us to offer our clients project-based and cost-effective immunoassay services, including:

 

• 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




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.