Antibodies for bioanalysis and drug monitoring of omalizumab and biosimilars

Develop highly selective and sensitive PK and ADA assays for the monoclonal antibody drug omalizumab (Xolair) using our range of ready-made anti-idiotypic and complex-specific antibodies.

  • Highly specific to omalizumab or the omalizumab-hIgE 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 Omalizumab and Omalizumab-hIgE Complex.

Specificity
Binding Type

Catalog Number

Clone

Format

Affinity* KD, nM

Assay Recommendation

Product Details

Omalizumab Inhibitory

Type 1

HCA236

AbD20669

Fab-FH1

1.1

PK bridging ELISA

Order HCA236

HCA235

HCA235P

AbD20669_hIgG1

Human IgG1

HRP

1.1

PK bridging ELISA

ADA control

Order HCA235

Order HCA235P

Omalizumab-hIgE Complex Specific

Type 3

HCA238

AbD20760

Fab-FH1

0.58

PK ELISA antigen capture format

Order HCA238

HCA237

HCA237P

AbD20760_hIgG1

Human IgG1

HRP

0.58

PK ELISA antigen capture format

Order HCA237

Order HCA237P

* Affinity measured in the monovalent Fab format
1 Monovalent Fab antibody DYKDDDDK and His-6-tags


Anti-Omalizumab Inhibitory Antibodies (Type 1)

Type 1 anti-omalizumab antibodies inhibit the binding of the drug omalizumab to its target, human immunoglobulin E (hIgE). They are ideal for development of a pharmacokinetic (PK) bridging ELISA to measure free drug. The antibody in fully human IgG1 format is suitable as a surrogate positive control or calibrator for an anti-drug antibody (ADA) assay.


Anti-Omalizumab-hIgE Complex Specific Antibody (Type 3)

The Type 3 antibody specifically recognizes the drug-target complex, detecting omalizumab only when it is bound to hIgE. It is suitable as a detection antibody in a PK antigen capture assay as an alternative assay format to the bridging ELISA.


ELISA Protocols to Get You Started

PK Bridging ELISA


Fig. 1. Omalizumab PK bridging ELISA using antibodies HCA236 and HCA235P.

Fig. 1. Omalizumab PK bridging ELISA using antibodies HCA236 and HCA235P.

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


PK Antigen Capture ELISA


Fig. 2. Omalizumab PK antigen capture ELISA using antibody HCA237P.

Fig. 2. Omalizumab PK antigen capture ELISA using antibody HCA237P.

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

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


ADA Bridging ELISA


Fig. 3. Omalizumab ADA bridging ELISA using antibody HCA235. Addition of human serum changes the binding curve due to the presence of endogenous IgE, which interferes with the assay.

Fig. 3. Omalizumab ADA bridging ELISA using antibody HCA235. Addition of human serum changes the binding curve due to the presence of endogenous IgE, which interferes with the assay.

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).



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