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Creative Diagnostics社 Advanced Development of Antibody-Drug Conjugate (ADC) Immunoassay at Creative Diagnostics

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Immunoassay of Antibody-Drug Conjugates (ADCs)

—Pharmacokinetic (PK) Characterization of ADCs

As a leader in the development of antibody-drug conjugates (ADCs), Creative Diagnostics has developed a portfolio of ELISA kits for the quantitative detection of conjugate antibodies targeting commonly encountered payloads such as MMAE, SN38 and DM1. These kits provide highly sensitive monitoring of conjugate antibody concentrations in serum and plasma, with high reproducibility and inter-batch consistency of test results. They are excellent tools for PK studies of ADCs.

 

For conjugated antibody quantification, the capture reagent is the antibody targeting the cytotoxic drug. After capturing the conjugated antibody, the amount is quantified using biotin antigen or anti-CDR mAb. 

 

ADC_Immunoassay_3.jpgFig.1 Principle of Conjugated Antibody Quantitative Detection

 

Key Features:

  • For PK assay of ADCs in pre-clinical/clinical studies (for research use only)
  • No cross-reactivity with other ADC analogs
  • Lot-to-lot consistency
  • High specificity/sensitivity/stability
  • Passed stability test at 37°C for 7 days

 

Performance Characteristics

The Intact MMAE ADC ELISA Kit (DEIABL314) developed by Creative Diagnostics has demonstrated excellent validation data as shown in the table below:

 

Precision

Intra-Assay (n = 32)

 

Inter-Assay (n = 16)

Sample

Mean Value [ng/ml]

CV [%]

 

Sample

Mean Value [ng/ml]

CV [%]

1

43.3

2.88%

 

1

130

6.82%

2

30

3.18%

 

2

43.3

4.40%

3

20

5.70%

 

3

14.4

1.90%

  

Recovery

Matrix

Recovery Range (%)

Average (%)

Sample 1 (n=5)

93-97%

94%

Sample 2 (n=5)

92-102%

98%

Sample 3 (n=5)

88-100%

90%

 

 

 

 

 

 

Analytical sensitivity

Limit of quantitation, LoQ

30 ppb

Detection Range

4.8-390.0 ppb

Linearity

0.991

 

Standard Curve

ADC_Immunoassay_4.pngFig.2 Typical Standard Curve of MMAE ADC ELISA Kit (DEIABL314)

 

Product List

Cat

Product name

DEIABL314

Intact MMAE ADC ELISA Kit

DEIABL315

Intact MMAF ADC ELISA Kit

DEIABL311

DM1 ADC EIA Kit

DEIABL316

SN38 ELISA Kit

DEIABL322

Doxorubicin ELISA Kit

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