Antibodies for bioanalysis and drug monitoring of trastuzumab and biosimilars

Develop highly selective and sensitive PK and ADA assays for trastuzumab (Herceptin) using our range of ready-made anti-idiotypic antibodies.

  • Highly specific to trastuzumab or the trastuzumab-ErbB2 complex
  • Fully human surrogate positive control or calibrator
  • Sequence defined, well characterized reagents with secure supply
  • Recombinant production, stringent quality control for batch to batch consistency
  • Non-animal-derived antibodies, reducing the use of animals in science

Table 1. Antibodies Specific to Trastuzumab and Trastuzumab-ErbB2 Complex.

Specificity Binding Type

Catalog Number

Clone

Format

Affinity* KD, nM

Assay Recommendation

Product Details

Trastuzumab Inhibitory

Type 1

HCA166

AbD16712

Fab-V5Sx21

0.2

PK bridging ELISA

Order HCA166

HCA167

AbD16714

Fab-V5Sx21

2.5

PK bridging ELISA

Order HCA167

HCA168

AbD18018

Fab-FH2

0.02

PK bridging ELISA

Order HCA168

HCA169

AbD18141

Fab-FH2

0.2

PK bridging ELISA

Order HCA169

HCA176
HCA176P

AbD16712_hIgG1

hIgG1 HRP

0.4

PK bridging ELISA

ADA control

Order HCA176
Order HCA176P

HCA177
HCA177P

AbD18018_hIgG1

hIgG1 HRP

0.02

PK bridging ELISA

ADA control

Order HCA177
Order HCA177P

HCA270

AbD18018_hIgG4Pro

hIgG4-Pro3

0.02

PK bridging ELISA

Order HCA270

Trastuzumab-ErbB2 (HER2) Complex Specific
Type 3

HCA263

AbD25279

Fab-A-FH4

31

PK ELISA antigen capture format

Order HCA263

* Affinity measured in the monovalent Fab format
1 Monovalent Fab antibody, V5- and StrepX-StrepX- tags
2 Monovalent Fab antibody DYKDDDDK- and His-6-tags
3 Human IgG4-Pro isotype has a point mutation S228P to prevent Fd half molecule exchange
4 Bivalent Fab2, bacterial alkaline phosphatase dimerization domain, DYKDDDDK- and His-6-tags

Anti-Trastuzumab Inhibitory Antibodies (Type 1)

Type 1 anti-trastuzumab antibodies inhibit the binding of the drug trastuzumab to its target, the extracellular domain of the human epidermal growth factor receptor 2, ErbB2 (also known as HER2). They are ideal for development of a pharmacokinetic (PK) bridging ELISA to measure free drug. In fully human IgG1 format they are suitable as a surrogate positive control or calibrator for an anti-drug antibody (ADA) assay.

Anti-Trastuzumab-ErbB2 Complex-Specific Antibody (Type 3)

The Type 3 antibody specifically recognizes the drug-target complex, detecting trastuzumab only when it is bound to ErbB2 (HER2). It is suitable as a detection antibody in a PK antigen capture assay.

ELISA Protocols to Get You Started

PK Assay Bridging ELISAs

HCA168 (capture) and HCA166 (detection)

HCA169 (capture) and HCA176P (detection)

Fig. 1. Trastuzumab PK bridging ELISA using antibodies HCA168 and HCA166

Fig. 1. Trastuzumab PK bridging ELISA using antibodies HCA168 and HCA166

Schematic image of PK bridging ELISA. Anti-idiotypic capture antibody, Fab format (purple), monoclonal antibody drug (gold), anti-idiotypic detection antibody, Ig format (blue), labeled with HRP.

Schematic image of PK bridging ELISA. Anti-idiotypic capture antibody, Fab format (purple), monoclonal antibody drug (gold), anti-idiotypic detection antibody, Ig format (blue), labeled with HRP.

HCA169 (capture) and HCA270 IgG4 isotype (detection)

Fig. 2. Trastuzumab PK bridging ELISA using antibodies HCA169, and HCA270 with HRP conjugated anti-hIgG4, MCA2098P (secondary).

Fig. 2. Trastuzumab PK bridging ELISA using antibodies HCA169 and HCA270, with HRP conjugated anti-hIgG4, MCA2098P (secondary).

Schematic image of PK bridging ELISA (IgG4). Anti-idiotypic capture antibody, Fab format (purple), monoclonal antibody drug (gold), detection with anti-idiotypic antibody IgG4 isotype format (blue), and anti-human IgG4 labeled with HRP (gray).

Schematic image of PK bridging ELISA (IgG4). Anti-idiotypic capture antibody, Fab format (purple), monoclonal antibody drug (gold), detection with anti-idiotypic antibody IgG4 isotype format (blue), and anti-human IgG4 labeled with HRP (gray).

PK Assay - Antigen Capture ELISA

PK antigen capture ELISA: ErbB2 (capture) and trastuzumab-ErbB2 complex-specific HCA263 (detection)

Fig. 3. Trastuzumab PK antigen capture ELISA using antibody HCA263.

Fig. 3. Trastuzumab PK antigen capture ELISA using antibody HCA263.

 

Schematic image of PK antigen capture ELISA. Drug target (red), monoclonal antibody drug (gold), drug target complex detection antibody, monovalent Fab format (purple), labeled with HRP.

Schematic image of PK antigen capture ELISA. Drug target (red), monoclonal antibody drug (gold), drug target complex detection antibody, monovalent Fab format (purple), labeled with HRP.

Anti-Drug Antibody Bridging ELISA

ADA bridging ELISA: HCA177 fully human IgG1 as surrogate positive control or calibrator

Fig. 4. Trastuzumab ADA bridging ELISA using antibody HCA177.

Fig. 4. Trastuzumab ADA bridging ELISA using antibody HCA177.

 

Schematic image of ADA bridging assay. Monoclonal antibody drug as capture antibody and detection antibody labeled with HRP (gold), fully human anti-idiotypic antibody, Ig format (blue).

Schematic image of ADA bridging assay. Monoclonal antibody drug as capture antibody and detection antibody labeled with HRP (gold), fully human anti-idiotypic antibody, Ig format (blue).

Related Products

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Trastuzumab biosimilar for research use Human Anti-ErbB2 Antibody (MCA6092)

Anti-pertuzumab antibodies

Resources

Anti-idiotypic antibodies, their binding types and properties

Anti-biotherapeutic antibody quality control and characterization

Custom anti-idiotypic antibody generation service

Licensed Use: For in vitro research purposes and for commercial applications for the provision of in vitro testing services to support preclinical and clinical drug development. Any re-sale in any form or any other commercial application needs a written agreement with Bio-Rad.