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…

What are functional assays? 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 in drug development are customized assays that evaluate the impact of drugs on the functionality of cells.

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…

At KCAS Bio, we supported a therapeutic monoclonal antibody for advanced solid tumors from non-human primate (NHP) toxicology through first-in-human (FIH) dose escalation into phase 2 expansion. This project combined receptor occupancy assays (ROA) by flow cytometry for cell-surface binding on monocytes, immunophenotyping (IPT) for activation markers,…

Developing a robust Pharmacokinetic (PK) assay for biotherapeutics often presents unforeseen biological hurdles. Occasionally, a traditional Ligand Binding Assay (LBA) may yield inconsistent data. In this particular case, the LBA assay was not reliably detecting drug in the matrix, potentially indicating some matrix stability issue during method development. In…

What Are Ligand Binding Assays (LBAs)? 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 a biologic and Anti-Drug Antibodies (ADA). What Are…

In a bioanalytical CRO, method development is a critical step to ensure reliable and meaningful data that meets the client’s requirements. At our KCAS Bio – Lyon site, our method development team specializes in designing and optimizing ligand-binding assay (LBA) methods tailored to our clients’ specific objectives.

What is Immunogenicity Assessment? Immunogenicity refers to the ability of a substance, such as a New Biological Entity (NBE) or a vaccine, to provoke an immune response when administered in the body. The recognition of the substance as foreign triggers an immune response, which involves the production of antibodies and…