Test item |
Analysis methods |
Reporter gene assay (RGA) |
- Immune Checkpoint RGA
- Bispecific RGA
- Fc Effector Function RGA: ADCC, ADCP
|
Translocation imaging assay |
PBMC activation |
- anti-CD3/CD28 stimulation
- Super antigen stimulation (SEA, SEB)
- Cytokine release detection
|
T/NK/B cell activation and expansion |
Tumor dependent immune system activation |
- BsAb (eg. CD3 x TAA), Reporter gene assay, Cytokine release assay
|
Fc dependent killing and phagocytosis assay |
- ADCC (FACS, LDH, RGA)
- ADCP (FACS, RGA)
- CDC
|
Fc independent killing |
- PBMC/CD8 T cell killing (CD3×TAA bispecific Ab)
- T cell specific killing
- NK-mediated killing
- CAR-T killing
|
Cytotoxicity assay (CellTiter-Glo) |
Bystander killing assay |
Proliferation assay (CFSE/BrdU/CellTiter-Glo) |
Cell panel screening (Viability/proliferation) |
3D culture assay (Proliferation, killing) |
Cell cycle analysis |
Apoptosis assay |
- PI/AnnexinV staining FACS
- Caspase 3/7 activation (Luminescence)
|
Monocyte survival |
Differentiation and polarization |
- DC differentiation
- Macrophage differentiation/polarization (M1/M2)
- T cell polarization (Th1, Th2, Th17, Treg)
|
Antibody Internalization |
- Direct detection by FACS/HCS
- Lysosome co-localization (Image)
- pHrodo (Operetta, FACS)
- Fab-Zap assay (CellTiter-Glo)
|
Cell Migration/Invasion Assay |
|
Surface marker profiling |
Target expression profiling on resting or activated cells |
Cytokine/chemokine profiling |
- ELISA/AlphaLISA/Elispot/CBA
|
Ex vivo tumor and TIL profiling |
CAR-T cell activation |
- CAR-T cell cytokine release
- CAR-T cell proliferation
|
CAR-T cell killing |
Allogeneic Mixed Lymphocytes Reaction (MLR) |
Antigen specific MLR/T cell recall assay (CMV, TT) |
T cell exhaustion |
Regulatory T cell assay |
- in vitro expansion
- T cell activation-suppression assay
|
Hemagglutination |
Metabolic diseases |
Infectious disease |
- Pseudovirus neutralization assay
- Antibody-dependent enhancement
|
In vitro safety evaluation |
- Immunogenicity evaluation
- Pre-ADA evaluation
- Cytokine release assay (PBMC, whole blood)
|
Developability evaluation |
- Serum/plasma stability test (human, cyno, mouse)
|