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…

The exploration of Targeted Protein Degraders (TPD) as a therapeutic modality began over twenty years ago. Since then, research and development in this field have steadily advanced. Starting in 2019, rationally designed small molecule TPDs entered clinical trials. This innovative therapeutic modality utilizes the cells’ endogenous protein degradation machinery to…

Preclinical formulation analysis supports toxicity studies before and after the investigational new drug application (IND). Multiple analytical studies support drug development progression beyond the IND stage. KCAS Bio performs analytical studies for a variety of clients. How Does KCAS Bio Perform Preclinical Formulation Analysis? KCAS Bio has completed numerous studies…

Cell and Gene Therapies (CGTs) are types of treatment that uses cellular or genetic material with the goal of treating a disease or a disordered. Often it can be a combination of cell and gene therapies, which is the case for Chimeric antigen receptor T cells (CAR T-Cells). There are…

Spectral flow cytometry and the growing array of commercially available fluorophores have led to the development of increasingly complex immunophenotyping panels.  Generating robust data depends not only on a strong panel design but also on the use of appropriate reference controls and a solid understanding of spectral unmixing principles. …

The Rise of Immune Cell Therapies and the Importance of Cell Profiling by Flow Cytometry Immunotherapy is revolutionizing patient care, both in traditional oncology applications as well as in autoimmune indications. The complex mechanism of action based on the enhancement or targeted suppression of immune responses is fraught with challenges;…

2020 was an odd year for everyone. In what felt like just days, it seemed everything had changed and the rules were being rewritten almost daily about how we would all be engaging with one another. We went from racking up travel, hotel stays and airmiles while visiting our customers…

Georges Köhler and César Milstein: The birth of monoclonal antibodies Since their initial invention almost 50 years ago in 1975, monoclonal antibodies have been widely utilized in the biomedical industry. From cancer treatment to diagnostic assays, over 100 monoclonal antibodies have been approved by the FDA, making them a…

A pharmacokinetic (PK) assays evaluate how the body affects a specific substance after administration which includes: absorption, biodistribution, metabolism, and excretion. Preclinical (or non-clinical) PK assays play a crucial role in drug development and typically focus on assessing drug safety and maximum tolerable dose. For the development of pre-clinical PK…

Charcot, Gehrig, Hawking: A Journey Through ALS When you hear the names Charcot, Gehrig, and Hawking, what comes to mind? These names are all linked by a shared thread: Amyotrophic Lateral Sclerosis, or ALS. ALS, also known as Charcot disease, is named after Jean-Martin Charcot, a neurologist from the Pitié-Salpêtrière…

The age of therapeutic conjugation is upon us! Bioanalysis for support of next-generation Antibody Drug Conjugates (ADCs) and Antibody siRNA Conjugates (ARCs) have exploded recently due to the efficacy and safety that these therapies offer for immuno-oncology, rare diseases, vaccines, and potentially many other diseases. Recently, we have seen the…

KCAS Bio is excited to invite you to join us this week in San Francisco, CA during AAPS NBC where Nassouh Mourabet will be giving a presentation entitled “Spectral Unmixing Impact Comparison Across Immunophenotyping Panels and Matrices”. Nassouh Mourabet is a Scientist III in the Flow Cytometry department at KCAS…