Bioanalytical Methods Validation

This webinar will review target areas addressed by FDA and EMA current guidance documents and ICH requirements. Current interpretation of guidance documents including failed runs, single stocks for standards and controls. Will address requirements for LC-MS, ligand binding and suggest requirements for cell based assays.
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OTHER ON-DEMAND WEBINARS

Single-cell multiomic analysis of T cell exhaustion in vitro

This webinar will demonstrate how the power of a single-cell multiomic approach can be harnessed to comprehensively characterize T cells, and precisely monitor changes in differentiation, activation, and exhaustion signatures during in vitro cell stimulation.
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Targeting Pre-Analytical Variables: Critical Quality Metrics in Cell Sample Prep for Cell-and-Gene Therapy Bioanalytics

Cell-mediated immunotherapies are an emerging modality that can revolutionize cancer research as well as the study of the immune system. However, establishing standardization and scalability for necessary bioanalytics into product release practices are hampered by two major challenges
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Integration of Technology, Process and Quality Control: Protecting Complete Sample Chain of Custody

Labroots

Implementation of biobanking best practices and analytical platform standardization are two important components for any data generation associated with state of the art biobanks that support precision medicine applications. Sample collection, pre analytical variables, controlled environment storage and sample processing can often have a large impact on the quality of biomaterials. This roundtable will describe how to standardize biobanking efforts in a manner commensurate with both academic and industrial partnerships. Data will be presented on the governance of biosample collections, standardization efforts, and quality control harmonization for biosamples as well as global best practices for the regulatory oversight of national and commercial biobank resources. Finally, a review of several international programs will illustrate how collaborative efforts are helping advance integrated biobanking precision medicine across many research and clinical areas.
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Decoding the Vaginal Microbiome

This webinar explores the complexities of the vaginal microbiome and new opportunities for Next-Gen Sequencing in women's health diagnostics.
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