| Bentuximab Vedotin

Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL.The drug is being jointly marketed by Millennium Pharmaceuticals outside the US and by Seagen in the US.
 

| 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 Human Bentuximab Vedotin 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)	92-105	97
Cell Culture Supernates(n=8)	95-110	98

 

| Linearity

Samples were spiked with high concentrations of Human Bentuximab Vedotin 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	93	108