Introduction to the speaker

Key points of the lecture

The lecture systematically introduced the application of flow cytometry in the whole life cycle quality control of cell therapy products, following the concept of "Quality by Design (QbD)", covering key aspects such as cell bank/cell matrix quality control, raw materials (such as viral vector titer testing), process control (transduction efficiency, cell subtype changes), finished product release testing (purity, biological efficacy), stability research and clinical immune monitoring. Taking the development of the CAR-T cell proportion method as an example, the entire process of detection reagent screening (Protein-L, G4S, recombinant antigen-Fc, anti-idiotypic antibodies, etc.), antibody titration, compensation adjustment, gating strategy, control settings (FMO control, isotype control) and methodological verification (referring to ICH Q2 and Chinese Pharmacopoeia 9101 guidelines) was demonstrated in detail. At the same time, he looked forward to the potential of new technologies such as mass spectrometry and spectral flow cytometry in ultra-high parameter analysis, and pointed out the core challenge facing the current field - the lack of standards (specific target antibodies, universal calibration microspheres, functional detection standards), and called on the industry and regulatory agencies to jointly promote the construction of a standard system.

The lecture directly addressed the four major pain points of organoid construction - "failure to grow large, unstable growth, insufficient personalization, and inaccurate evaluation." It was also pointed out that static culture leads to central necrosis, and a dynamic culture system is recommended. ； In view of the single cell type, the co-culture strategy of oligodendrocytes, microglia, vascular endothelial cells and brain organoids is introduced. It focused on the application of 3D bioprinting technology (extrusion + DLP) in accurately arranging cells and constructing vascularized tissues. At the functional assessment level, the emphasis is on expanding from morphology to multi-dimensional assessment such as multi-omics, electrophysiology (high-density microelectrode array), mechanics and in vivo transplantation functional verification.