Flow cytometry is one of the most valuable and versatile tools for multiparametric, single cell analysis. The technology has been used in research, clinical and industrial settings for more than 30 years. More recently, flow cytometry has become an integral component of the drug discovery and development process as novel therapeutic approaches targeting the immune system are being applied in oncology and infectious diseases. Arguably for cell therapies, flow cytometry is the most critical tool for purity, identity and potency evaluation during the manufacturing process. Flow cytometry data supporting manufacturing as well as safety and efficacy during clinical evaluation are critical components of biological license applications submitted to regulatory agencies.

As the technology advances and the applications of flow cytometry expand, it is increasingly important to ensure that measurements are made precisely and with certainty. In flow cytometry the quality pillars for building measurement assurance include: instrument characterization and standardization; developing and validating high quality methods; as well as monitoring instrument and assay performance. In the past few years, significant progress has been made in all three areas due to the efforts of the National Institute of Standards and Technology, the US Food and Drug Administration, the American Association of Pharmaceutical Scientists, the International Society for Advancement of Cytometry, and the International Clinical Cytometry Society .

This webinar will provide updates on the current best quality practices in flow cytometry and provide specific case studies.