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?

The age of cell and gene therapies (CGTs) is upon us! It has been a long road to get to this time. The first gene therapy trial on humans was performed in 1990 by researchers at the National Institutes of Health. The first FDA approved CGT came in 2017. One…

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…

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

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…