Bill Malone wrote a great article for Clinical laboratory News (American Assoc for Clinical Chemistry) that goes straight to the heart of the folklore and myth surrounding the use of automation in laboratories. Check out “Blood, Sweat, and Robots.”
The need to implement robust biomarkers in clinical trials has never been greater, and such efforts can be easily compromised by reagent instability or simple human error during assay set-up. Many biotechnology and pharmaceutical companies are introducing efforts to conduct biomarker studies under more rigorous settings, and the use of plates or tubes pre-loaded with stimulation or staining reagents could be of value for studies that involve flow cytometry.
The value of this approach is that it lends itself to assay automation easily and safeguards against omission or erroneous addition of bulk liquid formulations of PMA and ionomycin to the reaction vessel (i.e., plate or tube) and also lends itself to extended stability/shelf-life of these reagents. On the basis of this initial success, we plan to expand our evaluation of lyophilized reagents so that they can be incorporated into our clinical biomarker campaigns as appropriate.
The identification and application of correlates of immune response can enable significant time and money savings especially in clinical trial settings for vaccine and biologic R&D. To download, please fill in the form below: [email-download download_id="2" contact_form_id="3"]
How practical is it to run validated and standardized cellular assays to interrogate biomarker surrogate correlates of immunity in clinical trial settings? Can this be done with any level of confidence in the outcome? Can these assays be performed routinely?
Readers gain an understanding of the details and the high level considerations of assay qualification for difficult cell-based assays. The level of optimization described for cell-based assays lends itself to biomarker assay automation which can be used for biomarker qualification and validation studies to the satisfaction of the FDA, EMEA, and other regulatory agencies.
Cell-based assay platforms covered are flow cytometry, intracellular cytokine ICS, immunophenotyping, elispot, IHC, cylex, neutralization bioassays, and endpoint assays.
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