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…

Charcot, Gehrig, Hawking: A Journey Through ALS When you hear the names Charcot, Gehrig, and Hawking, what comes to mind? These names are all linked by a shared thread: Amyotrophic Lateral Sclerosis, or ALS. ALS, also known as Charcot disease, is named after Jean-Martin Charcot, a neurologist from the Pitié-Salpêtrière…

In the scientific field, the often neglected fifth sense, the sense of smell, contributes to broadening our understanding of various phenomena, particularly in the field of biomarkers.Here, we will guide you along our lines of thought on the importance of our olfactory sense, and how it contributes to scientific exploration…

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…

If you are part of the Biotech/Pharma community, you may be familiar with the (J.P. Morgan) JPM Healthcare Conference that takes place annually in January and typically in San Francisco. This was the 42nd Annual JPM Healthcare Conference and it is the world’s largest healthcare symposium. This year the mood…

Immunoassays are bioanalytical methods that generally use antibodies to detect and quantify specific analytes, often proteins, in biological samples. The process involves the capture of a target protein by an immobilized antibody, followed by its detection with another antibody conjugated either to enzymes, such as phosphatase alkaline or horseradish peroxidase…

Immunogenicity refers to the ability of a substance, such as an antigen or a vaccine, to provoke an immune response in an organism. The recognition of the substance as foreign triggers an immune response, which involves the production of antibodies and the activation of immune cells to fight against or…

ELISpot (Enzyme-linked immunosorbent spot) is an immunoassay-based technique used to quantify cells that are capable of secreting proteins, including cytokines, cytotoxic molecules, and antibodies, when stimulated with the appropriate antigen. Initially designed to monitor the frequency of circulating antigen-specific memory B-cells, it is now commonly used to determine the frequency…

Ligand binding assays (LBAs) have been our core activity for decades. LBAs are commonly used to measure interactions between two proteins, a ligand and its receptor, a monoclonal antibody (mAb) and its target, or biologics and Anti-Drug Antibodies (ADA). Throughout the development of New…

Biologics are drugs derived from complex molecules like antibodies. Over the last two decades they have re-emerged as…

Understanding the interactions between drugs and biological systems is critical for the success of a new drug. One key tool in this process is functional assays. Functional assays are customized assays that evaluate the impact of drugs on the functionality of cells. They test for a drug’s specific biological mechanism…