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Everything is a Biomarker: Insights on Integrated Bioanalysis
Everything Is a Biomarker A biomarker is a definition, not a category of assay. PK and immunogenicity both meet that definition, and that has real consequences for how we develop assays and interpret the data. In most labs, “biomarker” is treated as a category of work. It is a service line, a box on the…
A Single Low-Affinity Clone: The Downstream Consequences of Early Reagent Decisions in PK Bioanalysis
Introduction Rescue projects rarely arrive with a single, obvious point of failure. More often, the root cause traces back to an early decision that seemed reasonable at the time, one that compounds through development and validation and produces failures that become increasingly difficult to resolve. In this case, a PK assay had been developed for…
When the Target Is Also the Problem: Resolving compounding target interference in an ADA assay through heat inactivation
SME’s: Dr. Liz Culyba, Dr. Lisette Fred Lucena, Alexandra Sullivan Target interference in ADA assays is one of the more persistent frustrations in bioanalysis. It distorts data in ways that are difficult to characterize, hard to mitigate, and easy to underestimate until it is too late in development. The standard toolkit addresses most cases. But not all of them. …
