Figure 1: DXd ADC Pharmacokinetic ELISA Kit standard curve
A set of DXd-ADC calibration standards from 1,280 ng/mL to 20 ng/mL was then diluted with Sample Dilution Buffer with a volume ratio of 1:40.

DXd ADC Pharmacokinetic ELISA Kit

GenScript has comprehensively developed and validated the DXd ADC Pharmacokinetic ELISA Kit for the quantitative measurement of DXd-ADC in cynomolgus monkey serum and plasma.

產品編號	L00972
規格	96 Tests 定制報價
數量
價格	￥4980


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產品概述

Product Description

DXd-ADC technology is composed of an enzymatically cleavable tetrapeptide–based linker, a novel exatecan derivative (DXd) payload and an antibody drug ^[1–3]. For example, Trastuzumab deruxtecan (DS-8201a, T-DXd) is an DXd antibody-drug conjugate (DXd-ADC), composed of an enzymatically cleavable maleimide glycynglycyn-phenylalanyn-glycyn (GGFG) peptide linker, DXd, and an anti-HER2 antibody. DXd is a more potent DNA topoisomerase I (TOP1) inhibitor which has been proved to be cytotoxic to human cancer cell lines, such as KPL-4, NCI-N87, SK-BR-3, and MDA-MB-468 ^[2]. The DXd-ADC technology has a linker stable in plasma, a payload with a short systemic half-life, and an ADC in which the average drug-to-antibody ratio (DAR) can be optimized up to 8 for each target^[1–6].
GenScript has comprehensively developed and validated the DXd ADC Pharmacokinetic ELISA Kit for the quantitative measurement of DXd-ADC in cynomolgus monkey serum and plasma. This kit based on the ICH M10 and the FDA bioanalytical method validation guidance for industry, ensuring its precision, accuracy, dilutional linearity, specificity, selectivity, stability, and hook effect were acceptable ^[7-10]. The ELISA kit is a validated tool for DXd-ADC quantification in biological matrices for drug research and development.

產品簡介

LLOQ

20 ng/mL

ULOQ

1,280 ng/mL

Precision

Intra-assay: CV≤10%
Inter-assay: CV≤15%

Minimum required dilution (MRD)

1:40, validated non-human primate plasma

Kit Contents

Component	Quantity/Size	Part No.
Capture Plate	1 plate	N1-80
Standard Stock	1 vial (20 μL)	N1-10
100× Detection Antibody [HRP]	1 vial (150 μL)	N1-20
Sample Dilution Buffer	1 bottle (60 mL)	N1-60
20× Wash Solution	1 bottle (60 mL)	N1-70
Stop Solution	1 bottle (6 mL)	A1-50
TMB Solution	1 bottle (12 mL)	A1-40
Plate Sealer	2 pieces	N/A

Storage

The unopened kit is stable for at least 12 months from the date of manufacture at 2°C to 8°C, and the opened kit is stable for up to 30 days from the date of opening at 2°C to 8°C.

原理

Assay Principle

DXd ADC Pharmacokinetic ELISA Kit is a sandwich ELISA assay that utilizes an anti-DXd monoclonal antibody as the capture antibody and an anti-human IgG monoclonal antibody as the detection antibody. When standards or samples are added to the capture plate, the anti-DXd monoclonal antibody coating on the plate can capture the DXd-ADC present in the sample. Then the Horseradish Peroxidase (HRP) conjugated Anti-human IgG monoclonal antibody is added to interact with the DXd-ADC bound on the plate. After the washing steps, 3,3',5,5'-Tetramethylbenzidine solution (TMB Solution) is added, resulting in the formation of blue color. The reaction is stopped by adding Stop Solution. Adding the Stop Solution changes the color from blue to yellow. The intensity of the color can be read at 450 nm and 630 nm by a microplate reader. The quantity of DXd-ADC in the sample is accurately determined against a DXd-ADC standard curve.

Reference

1. Nakada T, Masuda T, Naito H, Yoshida M, Ashida S, Morita K, et al. Novelantibody drug conjugates containing exatecan derivative-based cytotoxicpayloads. Bioorganic Med Chem Lett 2016; 26:1542–5.
2. Ogitani Y, Aida T, Hagihara K,Yamaguchi J, Ishii C, Harada N, et al. DS-8201a, a novel HER2-targeting ADCwith a Novel DNA topoisomerase I inhibitor, demonstrates a promising antitumorefficacy with differentiation from T-DM1. Clin Cancer Res 2016; 22:5097–108.
3. Nakada T, Sugihara K, Jikoh T, Abe Y, Agatsuma T. The latest research anddevelopment into the antibody–drug conjugate, [fam-] trastuzumab deruxtecan(DS-8201a), for HER2 cancer therapy. Chem Pharm Bull 2019; 67:173–85.
4. Hashimoto Y, Koyama K, Kamai Y, Hirotani K, Ogitani Y, Zembutsu A, et al.A novel HER3-targeting antibody–drug conjugate, U3–1402, exhibits potenttherapeutic efficacy through the delivery of cytotoxic payload by efficientinternalization. Clin Cancer Res 2019; 25:7151–61.
5. Iida K, Abdelhamid Ahmed AH, Nagatsuma AK, ShibutaniT, Yasuda S, Kitamura M, et al. Identification and therapeutic targeting ofGPR20, selectively expressed in gastrointestinal stromal tumors, with DS-6157a,a first-in-class antibody-drug conjugate. Cancer Discov 2021; 11:1508–23.
6. Okajima D, Yasuda S, Maejima T, Karibe T, Sakurai K, Aida T, et al.Datopotamab deruxtecan, a novel TROP2-directed antibody–drug conjugate,demonstrates potent antitumor activity by efficient drug delivery to tumorcells. Mol Cancer Ther 2021; 20:2329–40.
7. International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use. ICH Harmonised Guideline, Bioanalytical MethodValidation M10 (2019).
8. US FDA. Bioanalytical Method Validation Guidance for Industry (2018).
9. European Medicines Agency. Guideline on Bioanalytical Method Validation(2011).
10. DeSilva B, Smith W, Weiner R et al. Recommendationsfor the bioanalytical method validation of ligand-binding assays to support.

圖例

Figure 1: DXd ADC Pharmacokinetic ELISA Kit standard curve
A set of DXd-ADC calibration standards from 1,280 ng/mL to 20 ng/mL was then diluted with Sample Dilution Buffer with a volume ratio of 1:40.

For research use only. Not intended for human and animal therapeutic or diagnostic use.

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DXd ADC Pharmacokinetic ELISA Kit

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