Patients Are People
The better we do our job, the faster you can help patients in need. We’ve succeeded in delivering many life-saving therapeutics on-time and in-scope. These therapeutics have earned FDA approval, with assay samples validated by BioAgilytix in under 2 months.
ADA Assessment for Cell Therapies
Cell therapies are emerging and evolving as promising therapies for a variety of disease indications. The ability to detect anti-drug antibodies (ADA) is important for patients receiving cell-based therapies. However, approaches to detecting ADAs against cell-surface biotherapeutics vary utilizing either traditional ligand binding assays or cell-based binding assays. Both ADA assay approaches have been utilized but there is no current regulatory guidance on which format is more appropriate for these therapeutics. In this presentation, we will discuss the challenges of both approaches and current industry practices.
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The BioAgilytix Perspective
Explore the BioAgilytix way of thinking. Visit our Resource Center to learn more about our scientists’ expertise through case studies, blogs, industry articles and other scientific resources.