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…

Although bioanalysis is KCAS’ principal area of expertise, we are always considering how we can build around those capabilities to ensure that we can provide optimal service for our clients. Our current breadth of service enables us to provide a comprehensive approach during non-GLP pre-clinical studies where it is feasible…

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…

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…

To read part one of this 2-part series, click here. With increasing focus on large molecule therapeutics and interest in large molecule biomarkers it’s essential to have LC/MS available as a complimentary technology to ligand…

Drug discovery is an essential part of the drug development process. Testing in drug discovery is the mechanism to provide drug candidates that are selected for regulated animal studies and hopefully moving into clinical trials.

Biomarkers can be defined and utilized for many purposes.  There are disease biomarkers as well as mechanistic or pharmacological biomarkers.  To reduce attrition and better understand a therapeutic, it is essential to be able to monitor the effectiveness of the therapeutic during drug development. Measurement of biomarker levels related to…

I have been studying Biological Markers (biomarkers) for over 25 years, but last 5 years they have exploded and become a key bioanalytical component to a drug’s success. Biomarkers are used to support drug…

The workflow for bioanalytical LC-MS/MS requires isolation of analytes of interest from biological samples prior to analysis. This usually involves an extraction procedure ahead of injection into the LC-MS/MS system where the target compounds…

A recent trend in the pipelines of pharmaceutical companies & biotechs has been a shift to large molecule therapeutics. This presents a challenge for bioanalysis by LC/MS because the molecular weights of the target…