As drug development programs continue to expand into more complex therapeutic modalities and patient-centric clinical trial designs, bioanalytical laboratories are under increasing pressure to generate high-quality data from smaller, less invasive samples. Volumetric absorptive microsampling (VAMS) has emerged as a promising solution, offering a practical alternative to traditional blood…

In today’s fast-moving drug development landscape, bioanalytical continuity and end-to-end support aren’t just conveniences, they’re competitive advantages. Sponsors navigating complex modalities like gene therapies, ADCs, oligonucleotides, and biologics need a partner who can keep pace with aggressive timelines, shifting priorities, and evolving regulatory expectations. Why Continuity Matters in…

What Are ADA Assays and Why Do They Matter? In both preclinical and clinical studies, evaluating immunogenicity, the immune system’s response to a foreign substance, is a critical factor. Anti-drug antibody (ADA) assays play a pivotal role in this evaluation, helping researchers and pharmaceutical companies determine how the immune…

In the drug development landscape, biomarkers are important tools that are used as strategic drivers of decision-making. From target engagement to safety monitoring and patient stratification, biomarkers accelerate clinical development and increase the probability of success. But not all biomarkers are created equal, and their value depends heavily…

What Are Neutralizing Antibody (NAb) Assays? Neutralizing antibodies (NAbs) are a subset of anti-drug antibodies (ADAs) that play an important role in evaluating the immunogenicity, safety, and efficacy of a drug product. For a deeper dive into ADA assays and their role in preclinical immunogenicity assessment, see our…

What is Immunogenicity? Immunogenicity, why do we keep talking about it? Immunogenicity can, in the simplest of terms, be described as a subject’s ability to generate antibodies specific to the dosed protein therapeutic. Why Does Immunogenicity Matter in Drug Development? Immunogenicity can be either a wanted or unwanted reaction. Wanted…

In the ever-evolving landscape of drug development, biomarkers have emerged as critical tools for the mechanism of action, early proof of mechanism, safety, predictive, efficacy, and monitoring treatment response. As the field advances, two major classes of biomarkers have come to the forefront: soluble biomarkers and cellular biomarkers.

KCAS Bio offers a wide range of biomarker services, from cell-based to soluble biomarker analysis, including ligand binding assays (LBA), across a variety of matrix types.  Soluble biomarker analysis can be achieved on multiple platforms depending on factors such as sample type, required sensitivity, and whether multiplexing…

Antibody-drug conjugates (ADCs) have been conventionally developed for a wide range of oncological applications since the first ADC approval in 2000 by the FDA. Typically, an ADC consists of three main components: antibody, linker conjugate, and therapeutic drug (payload). The mechanism of an ADC involves the antibody binding to a…

Biomarker assay development is pivotal to clinical research and the success of a study, yet the journey from qualification to validation is often complex. In this blog, we discuss four must-know essentials to optimize your assay development process. 1. Understand the Context of Use: Qualification vs. Validation 2. Choosing…

A pharmacokinetic (PK) assays evaluate how the body affects a specific substance after administration which includes: absorption, biodistribution, metabolism, and excretion. Preclinical (or non-clinical) PK assays play a crucial role in drug development and typically focus on assessing drug safety and maximum tolerable dose. For the development of pre-clinical…