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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…

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 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…

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…

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…

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…

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…

Introduction The January 2025 FDA guidance suggests using PK validation approaches as a starting point, but our extensive experience implementing biomarker assays reveals why specificity and selectivity demand fundamentally different scientific approaches. Understanding Traditional Drug Assay Validation In drug concentration assays, specificity, and selectivity are demonstrated through straightforward spike recovery experiments. Specificity evaluates reference standard…

Introduction The January 2025 FDA guidance maintains consistency with previous documents in suggesting biomarker validation should start with approaches used for drug assays. However, our extensive experience in biomarker implementation reveals why accuracy and precision require fundamentally different scientific approaches. Understanding Traditional Drug Assay Validation In drug concentration assays, accuracy and precision benefit from a…

February 5th, 2025, 2:30 PM EST- Editorial Note: We have observed that the January 2025 FDA Biomarker Assay Validation guidance document referenced in this post is currently inaccessible through the provided URL (listed in the reference section at the bottom of this article). This development, while noteworthy, does not impact the scientific principles discussed here….