With the rapid progress of immune-monitoring drug development, flow cytometry has found itself increasingly at the forefront of clinical trial assessment of safety and efficacy. This is not without challenges since flow cytometry analysis can be complicated and expensive, too often employs idiosyncratic experimental and analytical methods. So how can a platform without standardized methods and processes, be successfully applied to evaluate clinical endpoints? Several novel approaches to instrument calibration and experimental design are now helping to establish the harmonization of flow cytometry across multiple clinical labs. In this blog, we explore the importance of flow cytometry instrument setup and maintenance when analyzing samples from clinical trials.

What is the primary role of Natural Killer (NK) cells? Natural killer (NK) cells are the predominant innate immune cells that mediate anti-tumor and anti-viral responses, and therefore possess good clinical utilization (Abel et al. 2018). Natural killer cells comprise 10–15% of peripheral blood lymphocytes and classically display a half-life of approximately 7–10 days in the circulation (Moretta et al. 2000).

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?

Why is Viability Staining so important for flow cytometry analysis? It seems pretty easy, just mix your cells with antibody conjugates, incubate, wash and you are ready to acquire, but actually cell staining for flow cytometry analysis is far from simple, particularly when it comes to the optimal distinguishing of rare cell populations, or in the deciphering of a complex immune response. There are some key considerations to optimizing flow cytometry cell staining and it requires a disciplined approach to understand the impact of certain steps on the staining process. So, how well do you plan and optimize your staining conditions to ensure the highest quality of flow cytometry data? In this blog, we explore some rules of thumb for Good Staining Practices for flow cytometry

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…

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…

KCAS is a progressive growing contract research organization with dedicated groups in pharmaceutical services to perform early stage discovery rapid method development and analysis, as well as, regulated preclinical and clinical phases, with support offered through NDA submission. We have an arsenal of top of the line instrumentation with a…

Animal health programs have consistently been supported by KCAS with increasing study complexities although they have constituted a small percentage of the overall pharmaceutical development, these programs have consistently been supported by KCAS with increasing study complexities. ANIMAL HEALTH – LABORATORY SUPPORT KCAS is not only centrally located in…

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Several important classes of drugs are inherently unstable in biological fluids. Examples include alkylating agents, cytostatic nucleosides, drugs with ester, aldehyde, thiol, nitroxyl or lactone functional groups, and small molecule compounds with unstable metabolites, such as acylglucuronides. The rate at which an analyte degrades in blood, other biological fluids, or…

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…