Blog
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…
The Science of Biomarker Assay Validation: A Comprehensive Framework
While the January 2025 FDA guidance suggests PK approaches as starting points, our extensive experience implementing biomarker assays reveals why each validation parameter demands careful scientific consideration. Let’s explore how these distinct approaches come together to form a comprehensive, scientifically sound validation framework. Understanding the Fundamental Distinction The key to understanding biomarker validation lies in…
Understanding Biomarker Method Validation: A Scientific Approach to Sample Stability
The January 2025 FDA Biomarker Assay Validation guidance suggests starting with PK validation approaches. However, our extensive experience implementing biomarker assays reveals why sample stability assessment demands a fundamentally different scientific approach. Understanding Traditional Drug Assay Validation In drug concentration assays, stability evaluation follows a straightforward path: analysts prepare spiked control samples and demonstrate accurate…
Understanding Biomarker Method Validation: The Critical Role of Parallelism
The January 2025 FDA Biomarker Assay Validation guidance suggests using PK validation approaches as a starting point. However, when it comes to dilutional linearity and parallelism, our extensive implementation experience reveals a fundamental scientific distinction that demands careful consideration. Understanding Traditional Drug Assay Validation In drug concentration assays, dilutional linearity serves as a cornerstone validation…
Understanding Biomarker Method Validation: Establishing Quantitative Ranges – A Scientific Perspective
Introduction The January 2025 FDA Biomarker Assay Validation guidance suggests using PK validation approaches as a starting point. However, our extensive experience shows why quantitative range determination for biomarker assays demands a fundamentally different scientific approach. The Traditional Drug Assay Paradigm In drug concentration assays, establishing quantitative ranges follows a straightforward path: analysts confirm ranges…