When it comes to developing new therapies for inflammatory bowel diseases (IBD), having robust and reliable bioanalytical support is crucial. From the early stages of drug discovery to Phase III clinical trials, our comprehensive bioanalytical solutions are designed to enhance and accelerate your drug development journey in a GCP…

ADCs represent a promising class of targeted therapies, and understanding the intricacies of their analysis is crucial for their successful development. In this blog, we address common questions to guide you through the various considerations involved in ADC research and testing. We will cover key topics related to the…

Understanding the intricate relationship between drugs and the human body is crucial for effective medical treatments. Two fundamental concepts in pharmacology – pharmacokinetics and pharmacodynamics – play pivotal roles in this understanding. This blog post will delve into these concepts, exploring their differences and significance in drug development and clinical…

Cell-based immunotherapies like Chimeric Antigen Receptor (CAR)-T cell therapy have been transforming the treatment of hematologic malignancies for more than a decade. Several groundbreaking studies (1) have led to a growing interest in applying these cell-based therapies to other T and B cell-mediated diseases.  One emerging application of CARs is…

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…

What is a generic PK assay? A generic pharmacokinetic (PK) assay, also referred to as a universal PK assay for New Biologic Entities (NBE), is used to measure circulating human biotherapeutics—primarily antibody-based—post-administration across various non-human matrices. These assays are particularly beneficial when drug-specific reagents, such as anti-idiotype antibodies, are…

At KCAS Bio, we don’t just advance science—we cultivate an environment where talented professionals thrive. Our success is driven not only by groundbreaking innovation but also by a workplace culture that values and supports our people. We believe that when employees are engaged, motivated, and happy, they perform at their…

KCAS Bio is excited to expand our global reach by attending key conferences across Europe in 2025. These events bring together top experts in biotechnology, pharmaceuticals, and clinical research, providing a unique opportunity to discuss cutting-edge advancements, regulatory insights, and innovative solutions in bioanalytical and biomarker services. As we continue…

Antibody drug conjugates (ADCs) are important targeted therapies in oncology. These are complex moieties consisting of a cell-targeting antibody combined with an active payload through a chemical linker. Key Components to Monitor in PK Studies Two significant components to monitor for PK studies are the (1) intact antibody drug conjugate…

KCAS Bio launched an initiative to advance its Quality System through a 21 CFR Part 11 compliant electronic Quality Management System (eQMS) to be prepared for anticipated future regulatory requirements for Good Laboratory Practice (21 CFR 58). This was driven by the proposed rule from August 2016, the FDA is…

KCAS Bio is thrilled to announce our participation in several key scientific and bioanalytical events across the United States in the coming months. These conferences provide a unique platform to showcase our cutting-edge capabilities, engage with industry leaders, and explore innovative approaches to bioanalysis. From gene therapy to toxicology and…

Polymerase chain reaction (PCR) assays (including digital PCR and quantitative PCR) can be used to detect and measure nucleic acids such as DNA, RNA, small RNAs, and non-coding RNAs. What may be surprising is how few guidelines and whitepapers are available for bioanalytical support for regulated Bioanalysis by dPCR and…