GEN-MKT-18-7897-A
Jun 23, 2017 | Biopharma, Blogs, Pharma | 0 comments
Are you tasked with the bioanalysis of antibody drug conjugates (ADCs)? If so, you know they represent a rapidly growing class of biotherapeutics, but their unique chemical structure makes quantitative analysis particularly challenging.
So, what is the best technique to create a novel quantitative analysis solution that accelerates method development and improves the performance of ADC pharmacokinetic assays?
Typically used Ligand binding assays (LBA) such as Enzyme-Linked Immunosorbent Assays (ELISA) have many advantages. However, LBAs can suffer from high variability, limited dynamic range, and problems with selectivity. An alternative comes with liquid chromatography-tandem mass spectrometry (LC-MS/MS), which has found widespread use in the quantitative analysis of small molecule drugs. While LC-MS/MS assays are exceedingly selective, with excellent dynamic range and reproducibility, they can lack sensitivity when applied to protein therapeutics.
In search of a solution, our experts developed a unique workflow with outstanding results. We combined a universal immunocapture enrichment strategy with sample preparation and a hybrid LBA microflow LC-MS/MS technique and applied it to the total antibody analysis of the ADC of Ado-trastuzumab emtansine in plasma.Read the full report in Chromatography Today >
Some of the highlights:
Read the full article >
This hybrid LBA microflow LC-MS/MS workflow using high capacity streptavidin coated magnetic beads provides a customizable immunocapture strategy that enables the rapid development of high sensitivity pharmacokinetic assays of biotherapeutics during pre-clinical or phase HC studies.
The workflow applies to mAB based therapeutics and results in faster assay development with wide dynamic range, high selectivity, and high sensitivity, with a lower LLOQs than typically achieved by LC-MS/MS using a direct plasma or pellet digest.
Find out how our BioBA Solution can accelerate your biologics bioanalysis >
In monoclonal antibody (mAb) development, assessment of purity and integrity of the protein in question is critical. CE‑SDS is the gold standard assay and is routinely run from analytical development through QC and lot release. It’s trusted because it consistently delivers quantitative, size‑based insight into purity and fragmentation, and it fits naturally into regulated environments.
In drug discovery and development, Metabolite Identification (Met ID) plays a critical role in understanding biotransformation pathways, ensuring safety, and meeting regulatory requirements. Advanced mass spectrometry techniques have revolutionized this process, particularly through electron-based fragmentation methods such as Electron Activated Dissociation (EAD) and Electron Transfer Dissociation (ETD). While both techniques leverage electron interactions to generate informative fragment ions, they differ significantly in mechanism, performance, and suitability for Met ID workflows.
In analytical laboratories, performance is not optional. Whether supporting regulated pharmaceutical workflows, high-throughput CRO operations, clinical reporting, or food and environmental testing, your mass spectrometry and capillary electrophoresis systems are critical to productivity, compliance, and scientific confidence.
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