Flow Cytometry Services for Drug Development

We know how precious every whole blood sample is in a clinical trial. That's why we staff our clinical processing team with top level scientists and use our robust training processes to make sure that both our bench scientist and remote analysis teams are ready and waiting for samples Monday-Saturday.

Our senior scientists have more than 15 years of direct flow cytometry experience that they use to make advanced scientific concepts understandable for technical users and procurement teams alike. They participate on calls throughout your project so that you can have direct access to the experts who understand your assay best.

We regularly support sample analysis for phase 1-3 trials. Our proactive forecasting process means that we maintain sufficient capacity across both instruments and personnel to take on new projects when they come in. We make sure that your project and samples won't go out of stability in a prioritization queue.

You need the latest research tools to make next level advances with flow cytometry. That's why we've invested heavily in a state-of-the-art facility, cell sorting equipment, spectral flow cytometry capabilities and globally harmonized conventional flow cytometers.

From the first development worksheet to the final raw data file, you own every piece of information we generate. Because of this, we're happy to customize documents and share them directly so that there is transparency at every stage, and we can ensure the data is ready for your bioinformatics workflow as soon as you receive it.

We begin by first developing a full understanding of the research application of your assay to ensure that the sample matrix, flow cytometry panels, and gating strategies can be designed and optimized accordingly, and assure adherence to all regulatory guidelines and principles (GLP and GCLP). We then leverage our extensive experience and an in-house antibody titration library to efficiently develop assays to support your unique program.

Once an assay has been developed, the validation stage can begin to ensure the assay is robust and reliable. Assay validation is performed to demonstrate that the method displays the required performance characteristics over the designated range of conditions of the study. Unlike many other platforms, flow cytometry lacks target standards from regulatory agencies, so validation strategies and approaches differ across laboratories. However, since flow cytometry is considered an analytical method, the FDA requires clinical flow cytometric studies to meet specific analytical method validation criteria to confirm that the process is fit for its intended use: specificity, stability requirements, linearity, accuracy, detection limits, range, precision, limits of quantitation, and robustness.

FACS is a powerful tool that provides unmatched utility in translational and clinical research. Cell sorting requires considerable planning and technical optimization. Working with KCAS Bio’s cell sorting experts will help to ensure your cell sorting yields and purities are achieved. Our BD FACSymphony S6 supports cell sorting with up to 50 parameters of detection and 6-way bulk sorting or single-cell sorting. Consider the many ways sorting can enhance your research projects.

Our scientists have hundreds of collective years of experience operating 18 color instruments, and during that time we've developed an assay to identify almost every cell type imaginable. We've worked with T-cells, B-Cells, Myeloid/NK cells, and more in a variety of matrices from standard whole blood to dissociated tissues to urine.

We've developed and validated dozens of receptor occupancy assays for global clinical trials. We understand many of the risks and challenges associated with quantifying specific antigens at single or multiple processing sites. Our experienced staff is available to make recommendations on optimal panel design and validation to give your trial the best chance at successfully testing out pharmacodynamic hypotheses.

Assays like phospho-flow, Treg suppression, and intracellular cytokine quantification can be very sensitive to lab technique. Modern immunology workflows require lengthy and meticulous series of biological operations- this can translate into significant variability or compliance issues that can quickly turn the assay into random number generators rather than essential sources of pharmacodynamic information. Our staff have developed and deployed dozens of workflows to analyze phosphorylation, activation, and suppression of cell types of interest, and our record of conference posters and customer testimonials demonstrate why we get so many repeat requests for this type of assay.

All of our assays require meticulous attention to detail from the time a tube arrives in the lab until the time a result is transferred to our sponsors. We bring that same attention to detail to the sample preparation techniques- PBMC isolation, magnetic enrichment, or even cell sorting- to make sure that any sample we process is ready for downstream analysis.

Our expert staff have developed hybridomas as part of screening programs and have experience with thousands of antibodies in multiple matrices. We leverage all of that experience when we develop panels and translate that into reduced timelines and more initial project success.