One-stop support for ADA and PK analysis in antibody drug clinical studies — from critical reagent development and bioanalytical method establishment through to immunoassay kit production and delivery.
ADA and PK methods live or die on the quality of the critical reagent. We develop the anti-idiotype antibody first, then build and validate the assay around it.
An anti-idiotype antibody specifically recognises and binds the idiotype of an antibody drug. It is the core critical reagent for establishing pharmacokinetic (PK) and anti-drug antibody (ADA) analytical methods. Anti-idiotype antibodies fall into antigen non-neutralising, antigen-neutralising and antigen–antibody complex types, used to detect total drug, free drug and bound drug respectively. The difficulty lies in designing the immunisation and screening strategy around each drug's structural features, so that an antibody recognising the intended site is actually recovered.
| Deliverable | Performance criteria | Quantity | Timeline |
|---|---|---|---|
| Anti-idiotype rabbit polyclonal antibody |
|
≥ 5 mg; purity > 90% (SDS-PAGE); stability > 5 years | 10 weeks |
| Anti-idiotype mouse monoclonal antibody (antigen-neutralising / non-neutralising) |
|
≥ 2 lines each type; 5 mg per line; purity > 90% (SDS-PAGE); stability > 5 years | 8 weeks |
| Anti-idiotype mouse monoclonal antibody (antigen–antibody complex type) |
|
≥ 2 lines; 5 mg per line; purity > 90% (SDS-PAGE); stability > 5 years | 8 weeks |
| Anti-idiotype mouse monoclonal antibody pair (antigen non-neutralising / neutralising) |
|
≥ 1 pair each type (capture + detection); 5 mg per line; purity > 90% (SDS-PAGE); stability > 5 years | 8 weeks |
| Anti-idiotype mouse monoclonal antibody pair (antigen–antibody complex type) |
|
≥ 1 pair (capture + detection); 5 mg per line; purity > 90% (SDS-PAGE); stability > 5 years | 8 weeks |
| Item | Material |
|---|---|
| Anti-idiotype rabbit polyclonal antibody | Target antibody drug 10 mg (purity > 90%) |
| Anti-idiotype mouse monoclonal antibody (antigen-neutralising / non-neutralising) | Target antibody drug 0.5 mg (purity > 90%) |
| Anti-idiotype mouse monoclonal antibody (antigen–antibody complex type) | Target antibody drug 0.5 mg (purity > 90%) |
| Anti-idiotype mouse monoclonal antibody pair (antigen non-neutralising / neutralising) | Target antibody drug 0.5 mg (purity > 90%) |
| Anti-idiotype mouse monoclonal antibody pair (antigen–antibody complex type) | Target antibody drug 0.5 mg (purity > 90%) |
All client-supplied materials can be prepared by HKIG Immune Technology on your behalf.
ADA (anti-drug antibody) is the immune response a patient or test animal mounts against the administered antibody drug itself — the body treating a therapeutic protein as foreign. It is the core measure of immunogenicity and a mandatory regulatory item for every antibody new drug IND/NDA. We develop the kit and evaluate its performance.
| Deliverable | Composition and use | Specification and quantity | Timeline |
|---|---|---|---|
| ADA assay kit (bridging ELISA) | Capture: target antibody drug / Detection: enzyme-labelled secondary antibody against the drug | 96 T; 100 / 200 kits | 3 weeks |
| ADA assay kit (bridging CLIA) | Capture: target antibody drug / Detection: luminescent-labelled secondary antibody against the drug | 100 T; 100 / 200 kits | 3 weeks |
The client provides 5 mg or more of the target antibody drug.
| Performance indicator | Reference range (ELISA) | Reference range (CLIA) |
|---|---|---|
| Lower / upper limit of quantitation (LLoQ, ULoQ) | 10 pg/mL – 10 ng/mL | 2 pg/mL – 100 ng/mL |
| Measuring range | 1–2 Log | 3–6 Log |
| Precision (CV%, intra / inter plate) | < 15% | < 15% |
| Spike recovery | 80%–120% | 85%–115% |
| Linearity of dilution | 80%–120% | 85%–115% |
| Specificity | — | — |
| Stability | 1–3 Y | 1–3 Y |
Performance indicators are established with reference to in-vitro diagnostic medical device performance criteria. They do not represent ICH or other regulators' bioanalytical method performance standards.
Pharmacokinetic (PK) study of antibody drugs guides preclinical starting dose setting, clinical safety and efficacy evaluation, drug–drug interaction analysis, rational dosing and formulation improvement — a core component of new drug development. We develop the kit and evaluate its performance.
| Deliverable | Composition and use | Specification and quantity | Timeline |
|---|---|---|---|
| PK assay kit (indirect ELISA) | Capture: target antigen / Detection: enzyme-labelled anti-hFc secondary antibody — measures free drug (Fab unoccupied) | 96 T; 100 / 200 kits | 3 weeks |
| PK assay kit (indirect CLIA) | Capture: target antigen / Detection: luminescent-labelled anti-hFc secondary antibody — measures free drug (Fab unoccupied) | 100 T; 100 / 200 kits | 3 weeks |
| PK assay kit (sandwich ELISA) | Capture: anti-ID antibody / Detection: enzyme-labelled anti-ID secondary antibody — measures total or free drug | 96 T; 100 / 200 kits | 3 weeks |
| PK assay kit (sandwich CLIA) | Capture: anti-ID antibody / Detection: luminescent-labelled anti-ID secondary antibody — measures total or free drug | 100 T; 100 / 200 kits | 3 weeks |
| Performance indicator | Reference range (ELISA) | Reference range (CLIA) |
|---|---|---|
| Lower / upper limit of quantitation (LLoQ, ULoQ) | 10 pg/mL – 10 ng/mL | 2 pg/mL – 100 ng/mL |
| Measuring range | 1–2 Log | 3–6 Log |
| Precision (CV%, intra / inter plate) | < 15% | < 15% |
| Spike recovery | 80%–120% | 85%–115% |
| Linearity of dilution | 80%–120% | 85%–115% |
| Specificity | — | — |
| Stability | 1–3 Y | 1–3 Y |
Performance indicators are established with reference to in-vitro diagnostic medical device performance criteria. They do not represent ICH or other regulators' bioanalytical method performance standards.
Host cell protein (HCP) residue is a mandatory release test for every biologic drug substance, and generic kits cannot cover the HCP profile of a specific process. Covering the process-specific HCP spectrum requires a team with deep experience in HCP antibody and immunoassay kit development.
| Deliverable | Performance criteria | Quantity | Timeline |
|---|---|---|---|
| Anti-HCP polyclonal antibody | Coverage > 60% (2D-WB); purity > 90% (SDS-PAGE) | ≥ 5 mg | 10 weeks |
| HCP assay kit (ELISA) | Limit of quantitation, measuring range, precision, spike recovery, dilution linearity | 96 T; 100 / 200 kits | 3 weeks |
| Performance indicator | Reference range (ELISA) |
|---|---|
| Lower / upper limit of quantitation (LLoQ, ULoQ) | 10 pg/mL – 10 ng/mL |
| Measuring range | 1–2 Log |
| Precision (CV%, intra / inter plate) | < 15% |
| Spike recovery | 80%–120% |
| Linearity of dilution | 80%–120% |
| Specificity | — |
| Stability | 1–3 Y |
Performance indicators are established with reference to in-vitro diagnostic medical device performance criteria. They do not represent ICH or other regulators' bioanalytical method performance standards.
Send us the drug structure and the analyte you need to measure. We will propose the anti-idiotype strategy and the assay format.
Request a Quote →Looking for ready-to-ship kits? See ELISA kits.
