Due to its ability to analyze multiple parameters across different cell types within a sample, flow cytometry can provide very rich and clinically valuable data sets from even small volumes of blood. However, flow cytometry is a challenging platform to master, and requires significant investment into equipment and technical training. So, for many researchers, outsourcing flow cytometry to a Contract Research Organization (CROs) is both cost-effective and the best way to ensure the highest quality of data from their samples. So, what types of flow cytometry applications are the most outsourced to CROs?

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…

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…

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,…

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…

How will your background in science play a role in your new Senior Scientific Advisor position? I feel that my skill set has evolved consistently since my graduate degrees where I’ve learned different yet complimentary lessons about data presentation, data interpretation, marketing, customer partnering, optimizing operational processes, customer management and…

At KCAS, our Discovery group performs bioanalytical / biomarker method development that can include any of the various components required for a validated method under the GLP guidelines.  So why is Discovery group needed?  The beginning stage of drug development is a stage of trial and error.  It is generally…

At KCAS, we work with Director, VP, and C-level pharmaceutical and biotech executives that need to measure their drug or the effect of their drug in biological matrix. Many of our customers rely on…

The 505(b)(2) drug development path, in contrast to traditional development of a new, never been approved drug (described under 505(b)(1) of the Federal Food, Drug, and Cosmetic Act) or ANDA (described under Section 505(j) of the Act) for a generic drug that is no longer under patent…

Designing a tissue assay in accordance to the FDA bioanalytical method validation (BMV) guidance involves three key questions. First, can control tissue be easily obtained in bulk quantities or should a surrogate tissue approach be considered? Second, what sample processing procedures should be considered relative to the known stability of…