Products for ADC Pharmacokinetic Study

Overview Highlights ADC PK Study Products Case Study

Catalog Products » Antibodies » ADC PK Study Tools

Overview

Antibody-drug conjugates (ADCs) are biopharmaceutical products that consist of a monoclonal antibody conjugated to a small cytotoxic molecule drug (payload) through a chemical linker (Figure 1). They can accurately deliver potent cell-killing payloads to cancer cells by harnessing the highly specific targeting property of monoclonal antibodies, thus, minimizing damage to healthy cells. HER2, CD22, BCMA, and Claudin18.2 are popular target antigens of ADC drugs. MMAE, MMAF, DM1, and DXd are the most commonly used ADC payloads.

Understanding the pharmacokinetics (PK) properties of ADCs in pre-clinical and clinical studies is critical for their successful development. ELISA is a widely used LBA (ligand binding assay) method for ADC PK studies. GenScript provides a comprehensive portfolio of anti-payload antibodies, anti-idiotype antibodies, anti-human IgG Fc antibody, and recombinant target proteins to facilitate your ADC PK studies.

Figure 1. Model structure of ADC.
Retrieved from Fu et al. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. Nature, 2022

Antibodies

Highlights

High Specificity

Recognize a particular payload
No cross-reactivity with other payloads
Bind to both free and conjugated payloads

Perfect Qualification

Good performance in two LBA methods
Broad detection range with good linearity and sensitivity
Ideal for the development of the conjugated and total ADC assays

Comprehensive Validation

Comprehensive validation based on the ICH M10 guidelines
Valid MRD (minimal required dilution) test with cynomolgus monkey serum

ADC PK Study

Pharmacokinetics is the study and characterization of the time course of drug absorption, distribution, metabolism, and excretion (ADME). Due to the complexity of ADCs that combine an antibody, a cytotoxic drug (also known as payload), and a specialized chemical linker, there are several analytes that need to be measured to characterize ADC PK profiles, including

total antibody, which is the ADC with a drug-antibody ratio (DAR) higher than or equal to zero

drug-conjugated antibody, which is the ADC with a DAR greater than or equal to one

free drugs (payloads) or their metabolites

ELISA immunoassay is a commonly used quantitative analytical method to measure the total and drug-conjugated antibody kinetic profiles. Multiple formats as shown in Figure 2 can be applied to detect target analytes.

Figure 2. Schematic images of ELISA-based ADC PK study

Items	Formats	LBA (Capture-Detection)
Total Antibody Assay	1	anti-idiotype antibody - anti-human IgG Fc antibody
	2	target antigen - anti-human IgG Fc antibody
	3	anti-human IgG Fc antibody - anti-human IgG Fc antibody
	4	anti-idiotype antibody (A) - anti-idiotype antibody (B)
Drug-conjugated antibody Assay	1	anti-payload antibody - anti-human IgG Fc antibody
	2	anti-payload antibody - anti-idiotype antibody
	3	anti-payload antibody - target antigen

Products

GenScript provides anti-payload antibodies, anti-idiotype antibodies, anti-human IgG Fc antibody, and recombinant target proteins for measuring the conjugate and total antibody in ELISA immunoassays.

Anti-payload Antibodies

Cat. No.	Product Name	Price
A02217	DXd Antibody (39F4), mAb, Mouse	$160.00 40 μg
A02223	DM1 Antibody (15L2), mAb, Mouse	$160.00 40 μg
A02224	MMAE Antibody (69F7), mAb, Mouse	$160.00 40 μg
A02225	MMAF Antibody (11B8), mAb, Mouse	$160.00 40 μg

Anti-idiotype Antibodies

Anti-Cetuximab/Erbitux
(Target: EGF Receptor)

Anti-Daratumumab/Darzalex
(Target: CD38)

Anti-Obinutuzumab/Gazyva
(Target: CD20)

Anti-Panitumumab/Vectibix
(Target‎: EGF Receptor)

Anti-Pertuzumab/Perjeta
(Target: ‎HER2)

Anti-Rituximab/Rituxan
(Target‎: ‎CD20)

Anti-Trastuzumab/Herceptin
(Target: HER2)

Anti-Cetuximab/Erbitux (Target: EGF Receptor)

Cat. No.	Product Name	Price
A01938	Anti-Cetuximab Antibody (18D5), mAb, Mouse	$148.00 40 μg
A01939	Anti-Cetuximab Antibody (20H1), mAb, Mouse	$148.00 40 μg
A01991	MonoRab™ Anti-Cetuximab Antibody (69H10), mAb, Rabbit	$211.00 40 μg
A01992	MonoRab™ Anti-Cetuximab Antibody (90G3), mAb, Rabbit	$211.00 40 μg

Anti-Daratumumab/Darzalex (Target: CD38)

Cat. No.	Product Name	Quantity	Price	Order
A01996	Anti-Daratumumab Antibody (11F2), mAb, Mouse		$148.00 40 μg
A01997	Anti-Daratumumab Antibody (6A3), mAb, Mouse		$148.00 40 μg

Anti-Obinutuzumab/Gazyva (Target: CD20)

Cat. No.	Product Name	Price
A01945	Anti-Obinutuzumab Antibody (18H8), mAb, Mouse	$148.00 40 μg
A01946	Anti-Obinutuzumab Antibody (16B7), mAb, Mouse	$148.00 40 μg
A01966	MonoRab™ Anti-Obinutuzumab Antibody (8G12), mAb, Rabbit	$211.00 40 μg
A01967	MonoRab™ Anti-Obinutuzumab Antibody (169F10), mAb, Rabbit	$211.00 40 μg

Anti-Panitumumab/Vectibix (Target‎: EGF Receptor)

Cat. No.	Product Name	Quantity	Price	Order
A02099	Anti-Panitumumab Antibody (2E7), mAb, Mouse		$148.00 40 μg
A02100	Anti-Panitumumab Antibody (9G12), mAb, Mouse		$148.00 40 μg

Anti-Pertuzumab/Perjeta (Target: ‎HER2)

Cat. No.	Product Name	Quantity	Price	Order
A02150	Anti-Pertuzumab Antibody (1A3), mAb, Mouse		$148.00 40 μg
A02151	Anti-Pertuzumab Antibody (11H4), mAb, Mouse		$148.00 40 μg

Anti-Rituximab/Rituxan (Target‎: ‎CD20)

Cat. No.	Product Name	Price
A01942	MonoRab™ Anti-Rituximab Antibody (137C6), mAb, Rabbit	$211.00 40 μg
A01943	MonoRab™ Anti-Rituximab Antibody (194D7), mAb, Rabbit	$211.00 40 μg
A01969	Anti-Rituximab Antibody (6C1), mAb, Mouse	$148.00 40 μg
A01970	Anti-Rituximab Antibody (17B6), mAb, Mouse	$148.00 40 μg