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 >
Developing an analytical method can be one of the most rewarding jobs an analytical scientist can do, but it can also be one of the most complex and frustrating. To help guide your practical experiments and thought processes we spoke to Kean Woodmansey to benefit from his experience.
As analytical organizations grow, there is an even greater need to train scientists and operators more consistently to meet tight deadlines, handle increasing samples, and meet data quality expectations. A high rate of employee turnover also affects the productivity of labs worldwide. Consistent training helps today’s labs stay competitive, whether the goal is sample throughput, therapeutic development, or publication.
A few years ago, I was plotting along in my analytical job and keeping up-to-date with residue regulations took a considerable amount of time, but it was always manageable. Nowadays, we have PFAS.
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