The Importance of GLP Compliance Certificate for Bioanalytical CROs We are proud to celebrate the one-year anniversary of our Good Laboratory Practice (GLP) Test Facility based in Lyon (France), dedicated to…
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…
Intracellular cytokine staining (ICS) is a functional immunology assay that uses flow cytometry to assess cytokine production by individual cells. Cytokines play a critical role in developing both physiologically appropriate and pathological immune responses. Interferon-γ (IFN-γ) is an excellent example of this, where it has a key role in antiviral…
Oligonucleotide therapeutics have recently gained popularity as noted by recent increases in regulatory approvals of oligonucleotides as drugs, novel liquid nanoparticle delivery approaches, and on-target specificity. In the development of bioanalytical assays, there are many challenging aspects to consider when quantitating oligonucleotides, such as non-specific binding, stability, efficient ionization, sequence…
KCAS Bio has embarked on a global initiative to harmonize its spectral flow cytometry services across four labs in three countries, collaborating with Crux Biolabs and Cytek Biosciences. This effort ensures standardized flow cytometry services across sites in the U.S., Europe, and Australia. As trials increasingly span multiple regions, global…
We are thrilled to announce a major milestone in the evolution of our global clinical support services. After months of detailed planning, collaboration, and execution, we’ve successfully integrated spectral flow cytometry at our KCAS Bio sites in Philadelphia, PA, USA; Lyon, France; and Crux Biolabs, our…
Clinical sample kitting plays a vital role in drug development projects. It requires meticulous attention to detail and the experience necessary to ensure that each kit is crafted according to precise specifications. A well-organized clinical kit can be the difference between smooth operations and costly delays. At KCAS Bio, we…
KCAS Bio is excited to announce our participation in several premier conferences throughout the United States this fall. These events bring together experts, innovators, and leaders in pharmaceuticals, biotechnology, and clinical research to exchange insights, explore the latest technologies, and drive the future of scientific discovery. As a trusted provider…
When you examine how to develop and validate/qualify a Biodistribution assay by PCR…
KCAS Bio is excited to announce our participation in several key conferences throughout the world. These events present invaluable opportunities for collaboration, innovation, and the sharing of industry insights. As a leading provider of bioanalytical services, KCAS Bio is committed to engaging with thought leaders, scientists, and professionals worldwide to…
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,…
The Role of Pharmacokinetics (PK) in Drug R&D Pharmacokinetics (PK) is defined as the study of the fate of a new therapeutic entity (NTE) after it is administered into the body of animals or humans. It involves understanding how the drug is absorbed, distributed, metabolized, and eliminated (ADME). Essentially, PK…