Oligonucleotide therapeutics have recently gained popularity as noted by recent increases in regulatory approvals of oligonucleotides as drugs, novel liquid nanoparticle delivery approaches, and on-target specificity. In the development of bioanalytical assays, there are many challenging aspects to consider when quantitating oligonucleotides, such as non-specific binding, stability, efficient ionization,…

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…

Dr. Sohrab Habibi Goudarzi – Senior Director of Pharma Discovery and R&D Services, Bryan Parmentier – Senior Principal Scientist of Pharma Method Development, and Yu-Hui (Ann) Fu -Principal Scientist of Pharma Regulatory, along with other scientists at KCAS Bioanalytical & Biomarker Services, coauthored with scientists at Gilead Sciences, Inc. in…

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…

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…

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…