Executive Vice President InnoStar San Carlos, California
Flow Cytometry (FCM), due to its high-throughput, multi-parametric and precise analytical capabilities, has become an indispensable tool in clinical research, diagnosis and treatment monitoring. In recent years, with the rapid development of new biotechnologies and emerging cell and gene therapy drugs, the importance of some key endpoints measured by Flow Cytometry in regulated clinical studies has become even more prominent. Driven by the context-of-use, the validation of flow cytometry demonstrates the suitability of the method under specific application scenarios and experimental requirements by evaluating multiple performance parameters. Based on the complexity and diversity of Flow Cytometry, along with various approaches and challenges faced in clinical trials, the Bioanalysis Expert Committee of the Chinese Bioanalysis Forum (CBF) has organized industry experts to reach a consensus and standards on aspects such as the method development and validation of immunophenotyping, receptor occupancy and pharmacokinetics of cell therapies in clinical studies by Flow Cytometry, aiming to provide recommendations and references for the scientific and standardized conduct of such studies.
Learning Objectives:
To understand the complexity and variety of flow cytometry method validation approaches in China biopharmaceutical industry
To understand the consensus of the best practices developed by representatives from the China biopharmaceutical companies and CROs on clinical flow cytometry to support regulatory submissions
To learn the mission and accomplishments of the Chinese Bioanalysis Forum, and how this scientific community collaborates with AAPS BMPM community.
