Antibody-drug conjugates (ADCs) have been conventionally developed for a wide range of oncological applications since the first ADC approval in 2000 by the FDA. Typically, an ADC consists of three main components: antibody, linker conjugate, and therapeutic drug (payload). The mechanism of an ADC involves the antibody binding to a…
If you have trained in the field of immunology, it may not be uncommon to emerge with a self-characterization as either a “B-cell immunologist” or a “T-cell immunologist”. Historically, this distinction arose from years of specialization and the degrees of separation between T-cell and B-cell biology research. Approaches to therapeutic…
Managing clinical trials is no small feat, and when clients attempt to handle sample management without a dedicated kitting service, they often encounter avoidable challenges. Let’s explore these issues and how they can be resolved effectively to make your clinical trial experience seamless and stress-free. Common Challenges When Not Using…
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…
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…
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…