ResourceLife Sciences
Developing an inclusion and safety monitoring assay for a cell therapy clinical trial
28 Jun 2023A cell and gene therapy biopharma company needed a partner for clinical trial support. The immediate need was a quick turnaround time for the development and validation of a biomarker assay using next-generation sequencing (NGS). In this case study from Azenta, explore how the biopharma company was able to develop a comprehensive, fit-for-purpose sample sourcing, assay, and logistics solution that can extend further to the storage of samples.
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BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.Sample ProcessingSample processing is required to prepare samples prior to analysis. Technologies used for sample processing include homogenizers, grinders, mills and mixers.Biomarker DiscoveryClinical biomarkers refer to substances related to known medical conditions that can be accurately measured <i>in vitro</i>. Biomarkers can be used to diagnose presence of a disease and indicate disease severity. The discovery of new biomarkers is incredibly valuable in the field of diagnostics.