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 biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
At SCIEX, innovation doesn’t stop at instruments; it extends to how you interact with your LC-MS/MS or CE systems every day. That’s why we’re excited to introduce the SCIEX Now spring 2026 improvements: a set of meaningful enhancements shaped directly by your feedback.
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