| Bemarituzumab

Bemarituzumab is the world's first humanized monoclonal antibody targeting fibroblast growth factor receptor 2b (FGFR2b). It exerts anti-tumor effects through a dual mechanism of action. On the one hand, it highly selectively inhibits the binding of fibroblast growth factor (FGF) ligands to the FGFR2b receptor, blocking the FGFR signaling pathway. On the other hand, its Fc segment has been glycosylated engineered, which can induce enhanced antibody-dependent cellular cytotoxicity (ADCC) to cause anti-tumor effects.
 

| Typical data

As the OD values of the standard curve may vary according to the conditions of the actual assay performance (e.g. operator, pipetting technique, wash technique or temperature effects), the operator should establish a standard curve for each test. Typical standard curve and data are provided below for reference only.

 

Concentration (ng/mL)	50	25	12.5	6.25	3.12	1.56	0.78	0
OD	2.52	1.96	1.38	0.97	0.55	0.31	0.19	0.08
Corrected OD	2.44	1.88	1.3	0.89	0.47	0.23	0.11	-

 

| Repeatability

Intra-assay Precision (Precision within an assay)：CV% < 10%; Inter-assay Precision (Precision between assays)：CV% < 10%
 

| Recovery

The recovery of HumanBemarituzumab spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Serum(n=8)	84-101	96
Plasma(n=8)	92-105	102
Cell Culture Supernates(n=8)	96-108	102

 

| Linearity

Samples were spiked with high concentrations of HumanBemarituzumab and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Serum(n=4)	Plasma(n=4)	Cell Culture Supernates(n=4)
1 : 2	Range (%)	84-98	88-96	90-110
	Average (%)	91	93	96
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	94	98	108