Blog
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…
Critical Reagents: Strategic Planning, Thoughtful Selection, and the Role of Expert Partnership in Assay Success
What determines whether a PK assay succeeds often happens before development ever begins. This article from Immunologix Laboratories, co-authored with Dr. Liz Culyba of the Critical Reagents Group, examines how anti-idiotypic antibody selection, Fc format, affinity, and capture-detection pairing define assay performance, and what rigorous critical reagent planning looks like in practice. Download to explore the science behind getting reagent strategy right from the start.
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…
Apply the Method: A Rescue Project in PK and ADA Bioanalysis
Introduction PK and ADA assays developed for a bispecific monoclonal antibody were built using atypical assay formats and non-standard bioanalytical methods and reagents. When those reagents were transferred to the facility responsible for the in-life portion of the preclinical tox study, validation failed despite repeated attempts. Timelines for filing with the regulatory agency began to…
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. …
Pre-Study Validated Is Not the Same As Validated
A Perspective on Evidence Hierarchies in Bioanalytical Method Validation Attend any bioanalytical conference, and you’ll hear ‘validation’ referenced frequently. Rarely, however, is ‘in-study validation’ discussed with the same rigor That gap is worth paying attention to. When scientists say an assay is validated, or fully validated, they are almost universally referring to pre-study validation. In…
Signal-to-Noise: Why Immunogenicity Testing Needs More Context, Not More Cut Points
Immunogenicity to biologic therapies is, by definition, a biomarker, a measurable biological response to therapeutic exposure. However, industry practice often treats immunogenicity as a uniquely separate scientific area, relying on a standardized three-tier testing paradigm applied broadly across programs, regardless of the context of use. This one-size-fits-all approach arose from a reasonable desire to prevent…
Why Your CRO Should Understand Your Molecule’s Mechanism of Action
Why Your CRO Should Understand Your Molecule’s Mechanism of Action Every therapeutic protein has a story: how it binds, where it acts, and what factors impact its function. Yet in many bioanalytical laboratories, that story never makes it past the intake. For pharmacokinetic assays designed to measure drug concentration—the focus of this discussion—that disconnect between…
