Dose Formulation Analysis is an essential step in regulated nonclinical studies. Robust analytical methods, rapid turnaround, and efficient communication helps ensure the dose form results for your GLP studies are delivered on time. At KCAS Bio, our scientific expertise allows us to develop methods that achieve…
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…
As the bioanalytical market evolves at a rapid pace, KCAS Bio stands at the forefront, offering an innovative approach to challenges and opportunities alike. Drawing on the insights of our leadership team, we’ve compiled a global perspective on the state of the bioanalytical industry in 2024. Through thoughtful discussions with…
Drawing on the insights of our leadership team, we’ve compiled a global perspective on the state of the bioanalytical industry in 2024. Through thoughtful discussions with our CEO, John Bucksath, and key team members Amy Mize, Mouhssin Oufir, and Brian Wile, KCAS Bio delivers a roadmap…
Drawing on the insights of our leadership team, we’ve compiled a global perspective on the state of the bioanalytical industry in 2024. Through thoughtful discussions with our CEO, John Bucksath, and key team members Amy Mize, Mouhssin Oufir, and Brian Wile, KCAS Bio delivers a roadmap…
Drawing on the insights of our leadership team, we’ve compiled a global perspective on the state of the bioanalytical industry in 2024. Through thoughtful discussions with our CEO, John Bucksath, and key team members Amy Mize, Mouhssin Oufir, and Brian Wile, KCAS Bio delivers a roadmap…
Drawing on the insights of our leadership team, we’ve compiled a global perspective on the state of the bioanalytical industry in 2024. Through thoughtful discussions with our CEO, John Bucksath, and key team members Amy Mize, Mouhssin Oufir, and Brian Wile, KCAS Bio delivers a roadmap…
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…