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 The FDA emphasizes…

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. While stating it this way understates the complexity of the immune system and the methods needed to detect and characterize…

Webinar Description: Biomarkers are a critical aspect of bioanalytical testing, as they provide a vast amount of information, from the effects of a drug on the subject to determining the drug’s mechanism of action and the correct dose for a patient. When developing a biomarker, it is important to understand…

In both preclinical and clinical studies, evaluating immunogenicity—an 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 system reacts to therapeutic drugs. But what exactly is immunogenicity? Simply put,…

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 PK…

Neutralizing antibodies (NAbs) are a subset of Anti-drug antibodies (ADAs) that play an important role in understanding the efficacy and safety of a drug product. While most drugs are associated with low risk and do not require a validated NAb assay prior to testing Phase 3 samples, drugs associated with…

Over the past decade, a continued discussion point has been the idea around analyzing samples on Ligand Binding Assay (LBA) platforms in singlet (one well) versus the standard duplicate analysis (Single sample added to two different wells). In the recent M10 Bioanalytical Method Validation Guideline issued for guidance in June…

You might be asking what type of laboratory my biomarker assay requires or what level of qualification or validation my assay needs. These are complex questions which there continues to be a significant amount of misunderstanding around. Fortunately, KCAS Bio has extensive experience with both biomarker development and qualification/validation to…

KCAS is a rapidly growing industry leader that continues to increase its vast knowledge surrounding assay transfers not only internally but externally as well.  As KCAS expands as a global leader in the bioanalytical space we have taken our knowledge surrounding internal assay transfers and extended that knowledge to external…

With recent guidance released from the FDA, there are changes for PKs (Pharmacokinetics) and ADCs (Antibody Drug Conjugates) that must be clearly understood before making decisions for your drug product testing. ADCs combine the target specificity of monoclonal antibodies with the…