Antibodies for bioanalysis and drug monitoring of durvalumab and biosimilars

Develop highly selective and sensitive pharmacokinetic (PK) and anti-drug antibody (ADA) assays for the monoclonal antibody durvalumab (Imfinzi) using our range of ready-made antibodies.

  • Recombinant antibodies specific to durvalumab
  • TrailBlazer Antibody enabling site-directed conjugation and format switching
  • Fully human surrogate positive control or calibrator
  • Sequence-defined, well-characterized reagents with a secure supply
  • Stringent quality control for batch-to-batch consistency

Table 1. Antibodies Specific to Durvalumab.

Specificity
Binding Type

Catalog Number

Clone

Format

Affinity* KD, nM

Assay Recommendation

Product Details

Durvalumab Inhibitory Type 1

TZA004

AbD41327ad

Fab-F-Spy2-H1

3.6

PK bridging ELISA

Order TZA004

HCA359

AbD41310ia

Human IgG1

4.8

ADA control

Order HCA359

HCA360

AbD41313ia

Human IgG1

14

ADA bridging ELISA
ADA control

Order HCA360

Durvalumab / PD-L1 Complex Specific Type 3

TZA002

AbD41240ad

Fab-F-Spy2-H1

13

PK ELISA antigen capture format

Order TZA002

* Affinity measured in the monovalent Fab format.
1 Monovalent Fab antibody with (F) DYKDDDDK, (Spy2) SpyTag version 2, and (H) His-6-tags.


Anti-Durvalumab Inhibitory Antibodies (Type 1)

Type 1 anti-durvalumab antibodies inhibit the binding of the monoclonal antibody drug durvalumab to its target, human programmed death-ligand 1 (PD-L1). They are ideal for the development of a PK bridging ELISA to measure free drug. In fully human IgG1 format, they are available in two affinities and are suitable for use as a surrogate positive control or reference standard in an ADA assay.

TrailBlazer Antibodies, clones AbD41240ad (TZA002) and AbD41327ad (TZA004), have a SpyTag2 incorporated at the C-terminus of the antibody heavy chain. In a fast reaction that simply requires mixing at room temperature, these antibodies can form a covalent isopeptide bond to a SpyCatcher reagent, enabling site-directed conjugation or fast conversion to a bivalent Fab or a full-length Ig-like format within an hour.

Anti-Durvalumab- PD-L1 Complex-Specific Antibody (Type 3)

The Type 3 antibody specifically recognizes the drug-target complex, detecting durvalumab only when it is bound to PD-L1. It is suitable as a detection antibody in a PK antigen capture assay.


ELISA Protocols to Get You Started

PK Bridging ELISA

Fig. 1. Durvalumab PK bridging ELISA using antibodies TZA004 and HCA360.

Fig. 1. Durvalumab PK bridging ELISA using antibodies TZA004 and HCA360

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

Fig. 2. Durvalumab PK Antigen Capture ELISA using antibody TZA002.

Fig. 2. Durvalumab PK Antigen Capture ELISA using antibody TZA002.

Schematic image of anti-drug/target complex specific antibody in PK ELISA antigen capture format

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.


ADA Bridging ELISA

Fig. 3. Durvalumab ADA bridging ELISA using antibody HCA359 or HCA360.

Fig. 3. Durvalumab ADA bridging ELISA using antibody HCA359 or HCA360.

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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