Products for ADC Pharmacokinetic Study

Highlights

High Specificity

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

Perfect Qualification

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• 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

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• 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

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
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• Anti-idiotype Antibodies
  Anti-Cetuximab/Erbitux
  (Target: EGF Receptor) [4]

  Anti-Daratumumab/Darzalex
  (Target: CD38) [2]

  Anti-Obinutuzumab/Gazyva
  (Target: CD20) [4]

  Anti-Panitumumab/Vectibix
  (Target‎: EGF Receptor) [2]

  Anti-Pertuzumab/Perjeta
  (Target: ‎HER2) [2]

  Anti-Rituximab/Rituxan
  (Target‎: ‎CD20) [4]

  Anti-Trastuzumab/Herceptin
  (Target: HER2) [2]

  Anti-Cetuximab/Erbitux (Target: EGF Receptor)

  Cat. No.	Product Name	Quantity	Price	Order
  A01938	Anti-Cetuximab Antibody (18D5), mAb, Mouse		$139.00 40 μg
  A01939	Anti-Cetuximab Antibody (20H1), mAb, Mouse		$139.00 40 μg
  A01991	MonoRab™ Anti-Cetuximab Antibody (69H10), mAb, Rabbit		$198.00 40 μg
  A01992	MonoRab™ Anti-Cetuximab Antibody (90G3), mAb, Rabbit		$198.00 40 μg

  Anti-Daratumumab/Darzalex (Target: CD38)

  Cat. No.	Product Name	Quantity	Price	Order
  A01996	Anti-Daratumumab Antibody (11F2), mAb, Mouse		$139.00 40 μg
  A01997	Anti-Daratumumab Antibody (6A3), mAb, Mouse		$139.00 40 μg

  Anti-Obinutuzumab/Gazyva (Target: CD20)

  Cat. No.	Product Name	Quantity	Price	Order
  A01945	Anti-Obinutuzumab Antibody (18H8), mAb, Mouse		$139.00 40 μg
  A01946	Anti-Obinutuzumab Antibody (16B7), mAb, Mouse		$139.00 40 μg
  A01966	MonoRab™ Anti-Obinutuzumab Antibody (8G12), mAb, Rabbit		$198.00 40 μg
  A01967	MonoRab™ Anti-Obinutuzumab Antibody (169F10), mAb, Rabbit		$198.00 40 μg

  Anti-Panitumumab/Vectibix (Target‎: EGF Receptor)

  Cat. No.	Product Name	Quantity	Price	Order
  A02099	Anti-Panitumumab Antibody (2E7), mAb, Mouse		$139.00 40 μg
  A02100	Anti-Panitumumab Antibody (9G12), mAb, Mouse		$139.00 40 μg

  Anti-Pertuzumab/Perjeta (Target: ‎HER2)

  Cat. No.	Product Name	Quantity	Price	Order
  A02150	Anti-Pertuzumab Antibody (1A3), mAb, Mouse		$139.00 40 μg
  A02151	Anti-Pertuzumab Antibody (11H4), mAb, Mouse		$139.00 40 μg

  Anti-Rituximab/Rituxan (Target‎: ‎CD20)

  Cat. No.	Product Name	Quantity	Price	Order
  A01942	MonoRab™ Anti-Rituximab Antibody (137C6), mAb, Rabbit		$198.00 40 μg
  A01943	MonoRab™ Anti-Rituximab Antibody (194D7), mAb, Rabbit		$198.00 40 μg
  A01969	Anti-Rituximab Antibody (6C1), mAb, Mouse		$139.00 40 μg
  A01970	Anti-Rituximab Antibody (17B6), mAb, Mouse		$139.00 40 μg

  Anti-Trastuzumab/Herceptin (Target: HER2)

  Cat. No.	Product Name	Quantity	Price	Order
  A02032	Anti-Trastuzumab Antibody (11C4), mAb, Mouse		$139.00 40 μg
  A02033	Anti-Trastuzumab Antibody (15H2), mAb, Mouse		$139.00 40 μg

  Find More Anti-idiotype Antibodies!

• Anti-human IgG Fc Antibody

  Cat. No.	Product Name	Quantity	Price	Order
  A01854	Mouse Anti-Human IgG Fc Antibody (50B4A9)[HRP], mAb		$105.00 200 μl

• Recombinant Target Proteins

  Cat. No.	Product Name	Quantity	Price	Order
  Z02731	BCMA, Human		$165.00 20 μg 1 mg
  Z03194	EGFR, His, Human		$90.00 10 μg 50 μg 1 mg
  Z03504	CLDN18.2, His, Human		$220.00 10 μg 100 μg 1 mg
  Z03642	CD30, His, Human		$200.00 100 μg 1 mg
  Z03643	Siglec-2/CD22, hFc, Human		$220.00 100 μg

Case Study

• Drug-conjugated Antibody measurement by anti-payload antibody and anti-idiotype antibody
  

  Figure 3. Standard curve of DXd conjugated Trastuzumab Sandwich ELISA by anti-idiotype antibody and DXd Antibody. Based on drug-conjugated antibody assay format 2.

  The Sandwich ELISA assay was developed using Anti-Trastuzumab Antibody (15H2), mAb, Mouse (GenScript, A02033) and DXd Antibody (39F4), mAb, Mouse (GenScript, A02217) and as the capture and detection antibodies, respectively.

  In this ELISA assay, DXd Antibody (39F4), mAb, Mouse (GenScript, A02217) was labeled with HRP. GenScript can provide customized conjugation service for this product per customer's request.

  Capture antibody: Anti-Trastuzumab Antibody (15H2), mAb, Mouse, 2 μg/ml
  Detection antibody: DXd Antibody (39F4), mAb, Mouse, 0.22 μg/ml.

• Drug-conjugated Antibody measurement by anti-payload antibody and anti-Human IgG Fc antibody
  

  Figure 4. Standard curve of DXd conjugated Trastuzumab Sandwich ELISA by anti-Human IgG Fc antibody and DXd antibody in monkey serum. Based on drug-conjugated antibody assay format 1.

  The DXd conjugated Trastuzumab Sandwich ELISA assay was developed using DXd Antibody (39F4), mAb, Mouse (GenScript, A02217) and Mouse Anti-Human IgG Fc Antibody (50B4A9)[HRP], mAb (GenScript, A01854) as the capture and detection antibodies, respectively.

  The samples tested in this assay were DXd conjugated Trastuzumab. The control samples were not serum spiked. The monkey serum samples were spiked with cynomolgus monkey serum matrix.

• Total Antibody measurement by anti-idiotype antibody pairs
  

  Figure 5. Standard curve of Trastuzumab Sandwich ELISA. The Trastuzumab Sandwich ELISA assay was developed using Anti-Trastuzumab Antibody (11C4), mAb, Mouse (GenScript, A02032-40) and Anti-Trastuzumab Antibody (15H2), mAb, Mouse (GenScript, A02033-40) as the capture and detection antibodies, respectively. Based on total antibody assay format 4.

  In this ELISA assay, Anti-Trastuzumab Antibody (15H2), mAb, Mouse (GenScript, A02033-40) was labeled with Biotin.

  GenScript can provide customized conjugation services for this product per the customer's request. The sensitivity of detecting Trastuzumab was observed to be up to 61 pg/ml.

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