mAb Drug
Monitoring
ELISA
The world's largest commercial portfolio of therapeutic mAb drug monitoring ELISA — covering pharmacokinetics (PK), quantitative ADA detection, and world's-only neutralizing antibody (nAb) assays for several approved biologics. Extends to 40+ bispecific antibodies and 34+ ADC ELISA validated per ICH M10 guidelines.
World's Only nAb Assays → Assay SciencePK • Quantitative ADA • nAb — One Integrated Workflow
Immunogenicity assessment of therapeutic biologics requires three distinct assay types that answer fundamentally different questions. Regulatory agencies (FDA, EMA) recommend — and increasingly require — a tiered approach across all three. Most commercial suppliers cover PK. Krishgen covers all three for 360+ approved mAbs, bispecific antibodies, and ADCs — and for several biologics, is the only commercial source globally for any of them.
Measures total drug concentration in serum or plasma using anti-idiotypic antibody capture — recognising the unique binding site of the therapeutic mAb, not its target. Drug-specific detection even in the presence of the endogenous target or co-medications. Krishgen covers 360+ approved biologics; for a significant subset, we are the only commercial source globally.
Anti-idiotypic capture • ng/mL quantitationAnti-drug antibodies (ADA) can neutralise biologics, alter their PK, and trigger adverse immune events. Krishgen's quantitative ADA format uses validated reference standards to deliver calibrated ng/mL or IU/mL results — enabling inter-study and inter-laboratory comparability required for regulatory submissions and biosimilar immunogenicity packages.
Calibrated ng/mL • Regulatory gradeAn nAb specifically blocks the drug from binding its target — the clinically meaningful immune response that total ADA cannot distinguish. Developing nAb assays requires specialist anti-idiotypic reagents in a competitive inhibition format. For several approved IO and oncology biologics, Krishgen's nAb assay is the world's only commercially available format.
★ World's Only for Several Biologics| Parameter | Criterion | Standard |
|---|---|---|
| Precision (intra-assay) | CV <10% | US FDA Bioassay Guidelines |
| Precision (inter-assay) | CV <15% | US FDA Bioassay Guidelines |
| Dilutional linearity | Recovery 80–120% | Gold Ring Protocol (7-point) |
| Spike recovery | 85–120% | ICH M10 (ADC assays) |
| Reference standard | WHO/NIBSC-calibrated or innovator drug | All kits |
| Lot-to-lot consistency | Validated across ≥3 lots | ISO 13485 manufacturing |
| Sample types | Serum • EDTA plasma • Heparin • Citrate plasma | 100 µl sample volume |
Checkpoint Inhibitors — Anti-PD-1 / PD-L1 / CTLA-4
PK, quantitative ADA, and nAb assays are available for all 8 approved checkpoint inhibitors — pembrolizumab, nivolumab, ipilimumab, atezolizumab, durvalumab, avelumab, cemiplimab, and tremelimumab. For pembrolizumab, nivolumab, and ipilimumab, the nAb assay is available only from Krishgen. The complete per-drug workflow — including paired biomarker ELISA (sPD-1, sPD-L1, sCTLA-4) — is covered in full on the dedicated checkpoint subpage.
View Checkpoint & B7 Family Subpage — Full PK / ADA / nAb Tables →Anti-HER2 • Anti-VEGF • Anti-EGFR & Other Targeted mAbs
The extensive biosimilar landscape for trastuzumab, bevacizumab, and rituximab makes complete immunogenicity characterisation — including nAb assays — a high-volume research priority. Krishgen holds the world's only nAb assay for trastuzumab, bevacizumab, and rituximab. Paired biomarker ELISA (VEGF KB1155, VEGFR2 KBH4535) enable target engagement monitoring alongside drug PK.
Anti-HER2 / ErbB2
Trastuzumab • Pertuzumab • T-DM1 • T-DXd • Margetuximab| Drug (Brand) | Class | Indication | Drug PK | ADA | nAb |
|---|---|---|---|---|---|
| Trastuzumab (Herceptin / biosimilars) | Anti-HER2 mAb | HER2+ Breast • Gastric | Available | Available | World's Only |
| Pertuzumab (Perjeta) | Anti-HER2 mAb | HER2+ Breast (+ trastuzumab) | Available | Available | Available |
| Margetuximab (Margenza) | Fc-optimised anti-HER2 | HER2+ Breast (3rd line+) | Available | Available | Contact us |
Anti-VEGF / Anti-Angiogenic
Bevacizumab • Ramucirumab • Aflibercept| Drug (Brand) | Target | Indication | Drug PK | ADA | nAb | Biomarker |
|---|---|---|---|---|---|---|
| Bevacizumab (Avastin / biosimilars) | VEGF-A | CRC • NSCLC • Ovarian • GBM | Available | Available | World's Only | KB1155 |
| Ramucirumab (Cyramza) | VEGFR2 | Gastric • NSCLC • CRC • HCC | Available | Available | Available | KBH4535 |
| Aflibercept (Zaltrap) | VEGF-A/B • PlGF | mCRC (+ FOLFIRI) | Available | Available | Available | KB1155 |
Anti-EGFR & Other Targeted Biologics
Cetuximab • Panitumumab • Rituximab • Denosumab| Drug (Brand) | Target | Indication | Drug PK | ADA | nAb |
|---|---|---|---|---|---|
| Cetuximab (Erbitux) | EGFR | RAS WT CRC • HNSCC | Available | Available | Available |
| Panitumumab (Vectibix) | EGFR | RAS WT mCRC | Available | Available | Available |
| Rituximab (MabThera / biosimilars) | CD20 | DLBCL • FL • CLL • RA | Available | Available | World's Only |
| Denosumab (Xgeva / Prolia) | RANKL | Bone metastases • GCTB • Osteoporosis | Available | Available | Available |
★ World's Only = sole commercial source globally • Contact info@krishgen.com for catalogue numbers
BCMA / CD38 / SLAMF7 — Multiple Myeloma
The myeloma space has seen rapid biologic adoption. For daratumumab — now used in nearly every line of myeloma therapy — the nAb assay is available only from Krishgen. Soluble BCMA (KBH6650, Hu/Mouse) is a validated pharmacodynamic biomarker: it drops with effective anti-BCMA therapy and rises at relapse — making it a key companion readout alongside BCMA-targeting drug PK assays.
BCMA / CD38 / SLAMF7 — Multiple Myeloma Biologics
Daratumumab • Isatuximab • Belantamab • Teclistamab • Elotuzumab| Drug (Brand) | Target | Class | Drug PK | ADA | nAb | Biomarker ELISA |
|---|---|---|---|---|---|---|
| Daratumumab (Darzalex) | CD38 | Anti-CD38 mAb | Available | Available | World's Only | CD38 — Contact us |
| Isatuximab (Sarclisa) | CD38 | Anti-CD38 mAb | Available | Available | Available | CD38 — Contact us |
| Belantamab mafodotin (Blenrep) | BCMA | ADC | Available | Available | Available | KBH6650 • sBCMA |
| Teclistamab (Tecvayli) | BCMA × CD3 | Bispecific Ab | Available | Available | Available | KBH6650 • sBCMA |
| Elotuzumab (Empliciti) | SLAMF7 | Anti-SLAMF7 mAb | Available | Available | Available | SLAMF7 — Contact us |
Bispecific Antibodies — T Cell Engagers & Dual Checkpoint
CiteAb 2023 Innovation Award — Highly Commended
Krishgen's bispecific antibody ELISA portfolio was recognised at the CiteAb 2023 Awards in the Innovation category — the only ELISA supplier acknowledged for bsAb assay development. Our 40+ bispecific drug assays cover T cell-engaging BiTEs, NK cell engagers, and dual-checkpoint formats, including world's-only nAb assays for blinatumomab and mosunetuzumab.
Designing drug assays for bispecific antibodies is technically more challenging than for conventional mAbs — anti-idiotypic antibodies must be specific to the unique dual-binding architecture, and nAb assays require competitive inhibition against both target-binding arms. This is why the commercial catalogue for bsAb assays is sparse, and why world's-only nAb availability is concentrated in a very small number of suppliers.
Bispecific Antibodies — T Cell & NK Cell Engagers
40+ bsAb drug ELISA in catalogue| Drug (Brand) | Targets | Indication | Drug PK | ADA | nAb |
|---|---|---|---|---|---|
| Blinatumomab (Blincyto) | CD19 × CD3 | B-ALL • B-NHL | Available | Available | World's Only |
| Mosunetuzumab (Lunsumio) | CD20 × CD3 | Follicular lymphoma | Available | Available | World's Only |
| Amivantamab (Rybrevant) | EGFR × MET | NSCLC (EGFR exon 20 ins) | Available | Available | Available |
| Glofitamab (Columvi) | CD20 × CD3 | DLBCL • FL | Available | Available | Available |
| Teclistamab (Tecvayli) | BCMA × CD3 | Multiple Myeloma | Available | Available | Available |
| Talquetamab (Talvey) | GPRC5D × CD3 | Multiple Myeloma | Available | Available | Available |
| Epcoritamab (Epkinly) | CD3 × CD20 | DLBCL • FL | Available | Available | Available |
| Tebentafusp (Kimmtrak) | gp100 × CD3 | Uveal melanoma | Available | Available | Contact us |
40+ bispecific drug assays in catalogue — contact info@krishgen.com for the full list including elranatamab, linvoseltamab, inavolisib combinations, and further pipeline bsAbs.
Antibody-Drug Conjugate (ADC) Drug Quantitation ELISA
ADCs combine a tumour-targeting antibody with a cytotoxic payload via a chemical linker. Accurate PK quantitation is technically challenging — assays must measure total ADC, intact ADC, or unconjugated antibody depending on the study endpoint and ICH M10 requirements. All Krishgen ADC ELISA use lyophilized reference standards calibrated against WHO/NIBSC standards or commercially sourced innovator drug. Break-apart wells, CV <10%, recovery 85–120% across serum and EDTA/heparin/citrate plasma (100 µl sample volume).
ADC Drug Quantitation ELISA — ICH M10 Validated
34+ ADC drug ELISA in catalogue| ADC Drug (Brand) | Antibody Target | Payload | Primary Indication | PK ELISA |
|---|---|---|---|---|
| Trastuzumab emtansine / T-DM1 (Kadcyla) | HER2 | DM1 (maytansinoid) | HER2+ Breast | Available |
| Sacituzumab govitecan (Trodelvy) | TROP-2 | SN-38 | TNBC • Urothelial | Available |
| Enfortumab vedotin (Padcev) | Nectin-4 | MMAE | Urothelial carcinoma | Available |
| Polatuzumab vedotin (Polivy) | CD79b | MMAE | DLBCL | Available |
| Belantamab mafodotin (Blenrep) | BCMA | MMAF | Multiple Myeloma | Available |
| Gemtuzumab ozogamicin (Mylotarg) | CD33 | Calicheamicin | AML | Available |
| Brentuximab vedotin (Adcetris) | CD30 | MMAE | Hodgkin lymphoma • ALCL | Available |
| Tisotumab vedotin (Tivdak) | Tissue Factor | MMAE | Cervical cancer | Available |
| Patritumab deruxtecan | HER3 | DXd | NSCLC (EGFR-mutated) | Available |
| Disitamab vedotin (RC48) | HER2 | MMAE | HER2+ Gastric • Breast | Available |
| Ladiratuzumab vedotin | LIV-1 (ZIP6) | MMAE | Breast cancer | Available |
| Samrotamab vedotin | LRRC15 | MMAE | Sarcoma • Solid tumours | Available |
| Telisotuzumab vedotin | c-Met | MMAE | NSCLC (c-Met+) | Available |
| Denintuzumab mafodotin | CD19 | MMAF | B-ALL • DLBCL | Available |
| Vorsetuzumab mafodotin | CD70 | MMAF | RCC • DLBCL | Available |
34+ ADC ELISA in catalogue — contact info@krishgen.com for the full list including Azintuxizumab vedotin, Lupartumab amadotin, Pinatuzumab vedotin, Enapotamab vedotin, Citatuzumab bogatox, Lulizumab pegol, Moxetumomab pasudotox, Vadastuximab talirine, Aprutumab ixadotin, and further pipeline ADCs.
Beyond Oncology — Rheumatology, AMD & More
Krishgen's KRIBIOLISA™ drug monitoring portfolio extends well beyond oncology and IO. Anti-TNF biologics, IL-6 inhibitors, integrin blockers, AMD treatments, and anti-allergen mAbs are all covered — PK and ADA assays for the full biosimilar development workflow. Several of these agents (infliximab, adalimumab, bevacizumab, ranibizumab) are among the most biosimilar-developed drugs in the world, generating sustained demand for validated immunogenicity assays.
Anti-TNF / Rheumatology & Inflammation Biologics
Infliximab • Adalimumab • Etanercept • Ustekinumab • Golimumab + more| Drug (Brand) | Target / Class | Indication | Drug PK | ADA |
|---|---|---|---|---|
| Infliximab (Remicade / biosimilars) | Anti-TNFα mAb | RA • IBD • Psoriasis • AS | Available | Available |
| Adalimumab (Humira / biosimilars) | Anti-TNFα mAb | RA • IBD • Psoriasis • PsA | Available | Available |
| Etanercept (Enbrel / biosimilars) | TNFα receptor fusion | RA • Psoriasis • AS | Available | Available |
| Certolizumab pegol (Cimzia) | Anti-TNFα Fab-PEG | RA • Crohn's • PsA | Available | Available |
| Golimumab (Simponi) | Anti-TNFα mAb | RA • UC • AS | Available | Available |
| Ustekinumab (Stelara) | Anti-IL-12/23 p40 | Psoriasis • Crohn's • UC | Available | Available |
| Tocilizumab (Actemra) | Anti-IL-6R | RA • CRS • Giant cell arteritis | Available | Available |
| Natalizumab (Tysabri) | Anti-α4-integrin | MS • Crohn's disease | Available | Available |
| Vedolizumab (Entyvio) | Anti-α4β7 integrin | UC • Crohn's disease | Available | Available |
| Alemtuzumab (Lemtrada) | Anti-CD52 | MS • CLL | Available | Available |
AMD / Ophthalmic & Anti-Allergen mAbs
Ranibizumab • Omalizumab • Eculizumab| Drug (Brand) | Target / Class | Indication | Drug PK | ADA |
|---|---|---|---|---|
| Ranibizumab (Lucentis) | Anti-VEGF-A Fab fragment | Wet AMD • DME • Retinal vein occlusion | KBI1029 | KBI2029 |
| Omalizumab (Xolair) | Anti-IgE mAb | Allergic asthma • Chronic urticaria | Available | Available |
| Eculizumab (Soliris) | Anti-C5 complement | PNH • aHUS • Neuromyelitis optica | Available | Available |
A dedicated page covering anti-TNF, IL inhibitors, integrin blockers, complement therapies, AMD biologics, and anti-allergen mAbs — with the same full PK / ADA assay detail. Contact us now for any of these assays.
★ World's Only nAb Assays — What This Means
A neutralizing antibody (nAb) to drug assay detects the specific subset of ADA that blocks the therapeutic drug from binding its target — the clinically meaningful immunogenic response. Standard ADA assays detect all anti-drug antibodies but cannot distinguish neutralizing from non-neutralizing responses. Regulatory agencies increasingly require nAb data for biologic approvals and post-market commitments. Developing these assays requires proprietary anti-idiotypic antibodies in a competitive inhibition format — a significant technical investment that few organisations worldwide have made for approved oncology biologics. For the following drugs, Krishgen is the only commercial source globally for an nAb assay.
Competitive inhibition format. Detects patient antibodies that block pembrolizumab binding to PD-1. PK assay: KBI1084. Paired biomarker: sPD-1 KBBA50.
Competitive inhibition format. Detects antibodies blocking nivolumab–PD-1 interaction. Paired biomarker: sPD-1 KBBA50. Contact us for PK catalogue number.
Competitive inhibition format. Detects antibodies blocking ipilimumab–CTLA-4 binding. Paired biomarker: sCTLA-4 KBH0277.
Particularly valuable for biosimilar developers requiring comprehensive immunogenicity packages including nAb data for regulatory submission. Contact us for catalogue number.
High demand from active biosimilar development pipeline. Paired with VEGF biomarker ELISA KB1155 (7+ species) for complete target engagement package.
One of the most widely biosimilar-developed biologics globally. Rituximab nAb assay enables complete three-assay immunogenicity characterisation for regulatory packages.
Used in nearly every line of myeloma therapy. nAb assay enables the most complete immunogenicity characterisation for this class. Paired PD biomarker: sBCMA KBH6650.
Designing nAb assays for bsAbs requires blocking both target-binding domains — a technical challenge that is reflected in the extreme scarcity of commercial nAb assays for this class. Krishgen holds both.
This list covers the primary confirmed world's-only nAb assays. Additional nAb assays may be available — contact info@krishgen.com for the complete confirmed list.
KRIBIOLISA™ Drug Assays — All Classes at a Glance
Summary by class. Contact info@krishgen.com for individual catalogue numbers, validation guides, and NHP/other matrix availability.
| Drug Class | Key Drugs | PK Assays | ADA | nAb | World's Only nAb |
|---|---|---|---|---|---|
| Checkpoint Inhibitors | Pembrolizumab • Nivolumab • Ipilimumab • Atezolizumab • Durvalumab • Avelumab • Cemiplimab • Tremelimumab | 8 drugs | All 8 | All 8 | Pembro • Nivo • Ipi |
| Anti-HER2 | Trastuzumab • Pertuzumab • Margetuximab | 3 drugs | All 3 | All 3 | Trastuzumab |
| Anti-VEGF | Bevacizumab • Ramucirumab • Aflibercept | 3 drugs | All 3 | All 3 | Bevacizumab |
| Anti-EGFR & Other | Cetuximab • Panitumumab • Rituximab • Denosumab | 4 drugs | All 4 | All 4 | Rituximab |
| BCMA / CD38 / MM | Daratumumab • Isatuximab • Belantamab • Teclistamab • Elotuzumab | 5 drugs | All 5 | All 5 | Daratumumab |
| Bispecific Antibodies | Blinatumomab • Mosunetuzumab • Amivantamab • Glofitamab • Talquetamab • 35+ more | 40+ drugs | 40+ drugs | Select | Blina • Mosune |
| Rheumatology / AMD / Other | Infliximab • Adalimumab • Etanercept • Tocilizumab • Natalizumab • Vedolizumab • Ustekinumab • Golimumab • Certolizumab • Alemtuzumab • Ranibizumab • Omalizumab • Eculizumab | 13+ drugs | All 13+ | — | — | T-DM1 • Sacituzumab • Enfortumab • Polatuzumab • Belantamab • Gemtuzumab + 29 more | 34+ drugs | Select | — | — |
PKDrug quantitation ADAQuantitative anti-drug antibody nAbNeutralizing antibody to drug World's OnlySole commercial source globally
Common Questions — mAb Drug Monitoring ELISA
Can't Find Your Drug?
With 360+ assays in catalogue and custom development capability, contact us with your drug name and we’ll confirm availability or initiate development.