In pharmaceutical drug development, quality is critical.  The FDA relies on quality driven documents to make decisions on the safety and effectiveness of regulated products and the approval of those products.  While Quality Assurance (QA) is a clear regulatory requirement in some instances (i.e., studies required to be compliant with Good Laboratory Practices), it can […]

If you are looking to incorporate flow cytometry into your study or clinical trial, ensuring that precise and uniform data is generated by contract flow labs can seem difficult, or even overwhelming.  In fact, a study conducted by Maecker et al. 2005 revealed that in a protocol conducted across 15 different laboratories, the inter-laboratory coefficient […]

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Controls are a vital part of any rigorous scientific process. Any experiment worth its peer-reviewed credentials requires controls to verify these data are valid, and that variables outside of the parameter of interest are not confounding the results in any way. In the rapidly-expanding field of flow cytometry, it is no different.  However, finding the […]

For typical flow cytometry assays, specimens are processed separately with the antibody panels to enumerate lymphocyte subsets of interest, yielding a sample by sample processing for each individual being tested. Although several hundred samples can be processed using this approach, what if there were methods to optimize efficiency of the flow cytometry testing, depending on […]

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Not everyone can say that they work on a project that has the potential to benefit millions of patients.  But we do. e work for the UW Medicine Heart Regeneration Program (HRP) within the University of Washington’s Institute for Stem Cell and Regenerative Medicine.  HRP scientists have expertise in stem cell biology, cardiovascular medicine, Good […]

  When considering the applications of flow cytometry, many people think of immunophenotyping. This widespread technique involves labeling cells with fluorescent antibodies specific to certain cell types, and then identifying the relative size of cell populations in a sample by measuring the intensity of fluorescence. While this is useful in immunology, flow cytometry is capable […]

Introduction Flow cytometry assays are widely used to evaluate Pharmacodynamic (PD) effects of molecules during all phases of drug development.  Specimens for flow cytometry analysis are collected throughout the course of a study and often shipped to a central location for testing.  Testing at a central location mitigates variability resulting from differences in instrumentation, reagents, […]