When you examine how to develop and validate/qualify a Biodistribution assay by PCR…

Immunogenicity refers to the ability of a substance, such as an antigen or a vaccine, to provoke an immune response in an organism. The recognition of the substance as foreign triggers an immune response, which involves the production of antibodies and the activation of immune cells to fight against or…

Along with a series of studies we plan to present related to our experiences with hybrid LC-MS/MS technology, KCAS will also be presenting on a study where we analyzed a compound that involved looking at urea in plasma and lung fluid (urea, of course, being a biomarker). Urea is endogenous…

For years, Dawn Dufield, PhD and I have been doing our best to get the word out (via as many venues as possible) about KCAS’s unique expertise with hybrid LC-MS/MS. This year’s upcoming EBF meeting in Barcelona is just such an opportunity, and one we are very much looking…

The Pharm/Biotech industry’s main focus is on development of therapeutics to address unmet medical needs but sometimes, clinical trials lead to observations that lead to a change in research path for a drug. A good example is sildenafil that was originally studied for use in hypertension and angina pectoris. Observed…

Ligand binding assays (LBAs) have been our core activity for decades. LBAs are commonly used to measure interactions between two proteins, a ligand and its receptor, a monoclonal antibody (mAb) and its target, or biologics and Anti-Drug Antibodies (ADA). Throughout the development of New…

Anyone who has been following KCAS for any amount of time has likely heard us discuss the advantages of Hybrid LC-MS/MS for the bioanalysis of large molecules. As pioneers in the technology for many years, KCAS has become a strong proponent of working with our customers to demonstrate the quality…

In 2022 we had 42 FDA Drug Approvals and 3 were Gene Therapies using a viral vector.  2 of the approvals in 2022 were AAV based.  The third is manufactured by adding functional copies of the transgene to the patient’s own Hematopoietic Stem Cells (HSCs)…

Due to the relative maturity of the technology, most people’s instinct when thinking about bioanalysis of large molecules is towards ligand binding assays. However, we urge people to be open to a more flexible approach. Using hybrid LC-MS/MS can be an equally useful tool for quantitation of biological therapeutics and…

Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and…