Data can be the most important aspect of a GxP organization. Storage complexity and requirements are increasing, and cloud solutions can be an attractive option for maintaining this ever-growing pool of data. When considerations…

As a Senior Director for Discovery in the pharma division at KCAS, I would like people to think of “Bioanalytical Discovery” as a stage in drug development; one where you are doing your final…

When I’m asked about the best way to go about selecting a CRO, my mind goes back to my second day at Magellan Laboratories in 1999 when I started my career years ago in this business. I had a customer who told me what it would take to be a…

The benevolent COVID virus has brought our industry many “gifts.” One birthday present is like a jelly of the month club subscription, and it’s impacted all Central Labs and providers of Clinical Sample Collection Kits, without discretion: the shifting un-availability of important kit contents, like vacutainers and polypropylene tubes. While…

What is Hybrid LC-MS/MS? Technically Hybrid LC-MS/MS is a technique that combines an affinity capture step with LC-MS/MS detection. Usually it only requires one antibody, whereas a typical LBA technique will require two. Following affinity capture, it is common to include a digestion step to produce surrogate peptides, which are…

Although small molecules represent the majority of compounds in development as drug candidates, there is an increasing tendency to more complex molecular structures to address unmet molecular needs. This has been reflected in the…

In its simplest terms, Dose Formulation Analysis (DFA) verifies all solutions used in preclinical toxicology studies. For FDA IND applications, dose formulation analysis is critical. Some companies are unfamiliar with the DFA process or…

It was early March 2020, the tendons in my right hand were swollen and throbbing, and I was seeking to learn more about off-the-bench careers at CROs and finally retire from pipetting. A few…

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…

A recent trend observed at KCAS is that the bioanalytical needs of our clients’ projects are becoming more complex.  There is increasing focus on monitoring delivery of therapeutics to the target of interest. This…

There has been an increasing focus on large molecule therapeutics and pharmaceutical companies have increasingly aligned their development pipelines in that direction. This has resulted in more biological therapeutics coming to market.  Last year,…

Pharmacodynamics (PD) is defined as the study of the biochemical and physiological effects of drugs and the mechanisms of their actions. Where pharmacokinetics looks at how the organism processes the drug, pharmacodynamics studies how…