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 >
As therapeutic pipelines continue to diversify, bioanalysis is being asked to do more than ever before. From small molecules to complex biologics, today’s scientists must generate high‑quality, reliable data across a growing range of molecule types and workflows, often under increasing time pressure.
Regulated laboratories are evolving faster than ever. New analytical modalities, higher sample throughput, increasing regulatory scrutiny, and leaner teams are reshaping how work gets done. At the same time, expectations for data integrity, standardization, and operational efficiency continue to increase complexity and/or scope. In this environment, LC-MS software is no longer simply an instrument control platform—it has become a critical part of a laboratory’s quality management system. The question is no longer whether your lab has changed, but whether your software has evolved to support the way regulated labs operate today, and if they are ready and able to meet the demands, they will face tomorrow.
Analyst software has long been a trusted foundation in regulated LC-MS laboratories—and for many, it still performs reliably today. But regulated environments are evolving faster than ever. As labs transition to Windows 11, strengthen cybersecurity policies, modernize IT infrastructure, and prepare for future compliance expectations, software decisions are no longer just about what works today—they’re about managing tomorrow’s risk. Analyst will not be supported on Windows 11. While some labs may continue operating in unsupported environments temporarily, the bigger question is: when that risk becomes reality, will your lab be reacting under pressure—or executing a planned mitigation strategy with confidence?
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