| Zolbetuximab

Zolbetuximab is a monoclonal antibody used for the treatment of gastric cancer.It is a claudin 18.2-directed cytolytic antibody against isoform 2 of Claudin-18.Zolbetuximab was developed by Ganymed Pharmaceuticals.The most common adverse reactions include nausea, vomiting, decreased appetite, neutropenia (low levels of neutrophils, a type of white blood cell that fights infections), decreased neutrophil counts, weight loss, fever, hypoalbuminemia (low levels of albumin, a blood protein), and peripheral edema (swelling, especially of the ankles and feet).
 

| 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	1.56	1.14	0.76	0.49	0.33	0.24	0.1
Corrected OD	1.9	1.46	1.04	0.66	0.39	0.23	0.14	-

 

| Repeatability

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

| Recovery

The recovery of HumanZolbetuximab 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)	84-108	90
Plasma(n=8)	92-103	98
Cell Culture Supernates(n=8)	95-110	97

 

| Linearity

Samples were spiked with high concentrations of HumanZolbetuximab 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 (%)	92	91	96
1 : 4	Range (%)	89-103	87-108	105-115
	Average (%)	96	94	105