ADCC, CDC and ADCP assays are relatively complex experiments, and many factors play roles to determine the success of the assay, including:

  1. Target molecule expression level on the target cell surface;
  2. Binding affinity of the antibody drug with the target molecule;
  3. The antibody drug IgG subclass;
  4. Potential effector function blockade mechanism on the target cell;
  5. Binding epitope on the target molecule for the antibody drug.

We will thoroughly evaluate your project and make our way to counter potential project risks to the largest extent. Our delivery standard, deliverables and project turnaround time are as follows:

Assay Type Delivery Standard Deliverable Turnaround Time
ADCC The EC50 value of the positive control falls within 5-fold range of the historic average value Raw data, Processed data, and final report 3 weeks
CDC 3 weeks
ADCP 4 weeks

Please download our quotation form, fill it carefully and send it to us at [email protected] for a free project evaluation.

ADCC Assay

There are two formats of ADCC assays at in vitro bioassay platform:

Strategy Target Cell Effector Cell Features Application
1 Tumor cell line/ target overexpressing cell line Prequalify PBMC/primary NK cell
  • Primary cells are used which are more relevant and reflective of the in vivo environment.
  • Relatively high cost and possibility in lot to lot variability.
Functional characterization in early drug discovery and development.
2 Tumor cell line/ target overexpressing cell line ADCC reporter cell line
  • Surrogate ADCC assay with luminescence signal as the readout.
  • High performance in stability and cost-effective.
  • High throughput screening in early drug discovery.
  • QC lot release during CMC stage

ADCC Service Key Features:

  • Published and functionally validated benchmarks are freely available
  • Large target cell collection comprising of >200 tumor cell lines and >100 target-overexpressing cell lines
  • Human PBMCs with proven ADCC function are available with ethics approval
  • ADCC reporter assay is well developed and validated
  • A highly professional and skilled team with extensive IND-filing experiences
  • Assay instruments are IQ, OQ and PQ-certified with audit trails
  • Established assays are available for CD20, Her2, CD38, EGFR, PD-L1, mTNFα, B7H3, Claudin 6 and Claudin 18.2, etc

Case Study

  • add-cmc-case-study-image6

    Case 1: Rituximab mediates ADCC effect in a dose-dependent format. Primary human PBMCs and Raji cells are used as the effector and target cells

  • add-cmc-case-study-image7

    Case 2: Anti-Claudin 18.2 antibody mediates ADCC effect in a dose-dependent format. ADCC reporter cells and human Claudin 18.2 overexpressing cells are used as the effector and target cells.

CDC assay

Strategy Target Cell Effector Cell Features Application
1 Tumor cell line/ target overexpressing cell line1 Pooled Norm Human Serum (PNHS) 2
  • Sera are used which is more relevant and reflective of the in vivo environment.
  • Prediction of stabilities of antibody candidates in serum.
Functional characterization in early drug discovery and development
2 Tumor cell line/ target overexpressing cell line Normal Human Serum Complement (NHSC)
  • High performance in sensitivity
Functional characterization in early drug discovery and development

1 A large collection of target-overexpressing cell lines is freely available

2 Pooled normal human serum (PNHS) and normal human serum complement protein (NHSC) have comparable effector functions in our CDC assays

CDC Service Features

  • Published and functionally validated benchmarks are freely available
  • Large target cell collection comprising of >200 tumor cell lines and >100 target-overexpressing cell lines
  • Suitable for mouse antibodies
  • A highly professional and skilled team with extensive INDfiling experiences
  • Assay instruments are IQ, OQ and PQ-certified with audit trails
  • Established assays are available for CD20, Her2, CD38, EGFR, PD-L1, mTNFα, B7H3, Claudin 6 and Claudin 18.2, etc

Case Study

  • add-cmc-case-study-image6

    Case 1: Adalimumab mediated CDC dose response curves. mTNFα overexpressing cells are used as the target cells, and PNHS (blue) or NHSC(red) are effector molecules.

  • add-cmc-case-study-image7

    Case 2: Rituximab mediated CDC dose response curves. Raji cells are used as the target cells, and PNHS (blue) or NHSC (red) are effector molecules.

ADCP Assay

Strategy Target Cell Effector Cell Advantage Disadvantage Application
1 Tumor cell line M1/M2 type macrophages1 Close to an in vivo immune microenvironment Relatively high price, low data reproducibility between cell batches, tumor cell surface can express "don't eat me" signaling resulting in negative data Antibody functional confirmation
2 Target overexpression cell line M1/M2 type macrophages Reflects actual phagocytosis effect, engineered cell line without "don't eat me“ signaling may improve the experiment success rate Extra cost on cell engineering2, using primary cells cost higher, relatively low data reproducibility Early antibody screening or functional confirmation3
3 Target overexpression cell line ADCP Reporter Cell Line Low cost, high reproducibility, high success rate No actual phagocytosis effect shown Early antibody screening, batch-release during CMC stage

1 Macrophages can be differentiated into M1 or M2 type
2 GenScript ProBio has a large collection of target-overexpressing cell lines, which are freely available to our clients
3 Early screening refers to the antibody drug discovery stage prior to humanization

ADCP Service Features

  • Extensive experience from more than a hundred of projects
  • Therapeutic antibody positive controls* for popular targets are freely available
  • Stringent QC criteria during macrophage differentiation and maturation
  • Fully validated ADCP reporter gene assay method is available
  • Stringent documentation system that meets the requirement of IND-filing

*CD20, CD38, CD47/SIRPα and Claudin 18.2, etc

Case Study

ADCP assay detection:

Two distinct fluorescence dyes are used to label the target cells and the effector cells, respectively. The population of Q2 quadrant which showing double positive is the group of target cells consuming by phagocytosis. The macrophage phagocytosis percentage is calculated as Q2/(Q2+Q3)*100%.

  • add-cmc-case-study-image6

    Without antibody

  • add-cmc-case-study-image7

    With antibody

  • add-cmc-case-study-image7

    SampleA(Conc.μg/mL)