Therapeutic Antibodies & Biosimilar ELISA Kits

Therapeutic Antibodies & Biosimilar ELISA Kits

Therapeutic Drug Monitoring

Therapeutic antibody & biosimilar ELISA kits

Sensitive, quantitative free-drug and anti-drug antibody (ADA) ELISA kits for pharmacokinetic, immunogenicity and biosimilarity studies — covering 30+ biologics including adalimumab, trastuzumab, pembrolizumab, nivolumab, rituximab and tocilizumab.

ISO 13485 certifiedng/mL sensitivity<25 µL sample
Researcher pipetting serum samples for a therapeutic antibody ELISA
30+ biologicsFree drug & ADA kits
70+
Drug-monitoring kits
Free & ADA
Assay formats
70–140 min
Protocol time
ISO 13485
Certified manufacture
Formats

Kits for the full drug-monitoring workflow

Therapeutic mAb ELISA

Screening and quantification of biologic drugs in serum and plasma.

Biosimilar ELISA

For QC, PK and biosimilarity assessment against the reference product.

ADA ELISA

Detect anti-drug antibodies — qualitative, quantitative and free/total.

Custom ELISA

Bespoke assay development for your drug on request. Contact us.

Applications

What these kits measure

Free drug: therapeutic mAb & biosimilar

Quality control during development and manufacture, biosimilarity assessment against the reference product, pharmacokinetic (PK) studies to guide dosing, and monitoring of drug levels in samples during clinical development.

Anti-drug antibodies (ADA)

Immunogenicity assessment, analysis of response variability between subjects, biosimilar immunogenicity profiling, and free-vs-total ADA measurement using acid dissociation to break drug–ADA complexes.

How it works

Sandwich ELISA detection in four steps

1

Capture

Pre-coated capture reagent binds the drug or ADA from serum or plasma.

2

Detect

An enzyme-linked detection antibody binds the captured analyte.

3

Develop

Substrate produces a colour change proportional to analyte level.

4

Read

Measure OD on a plate reader and read off the standard curve.

Performance

Built for PK and immunogenicity studies

Highly sensitive

Detection in the ng/mL range in serum and plasma.

Low sample volume

Under 25 µL of sample per test.

Fast results

Complete in 70–140 minutes.

High recovery

85–115% recovery, validated in human samples.

One-year shelf life

Lot-to-lot consistency for longitudinal studies.

Multiple formats

Qualitative, quantitative and free/total kits.

ISO 13485:2016ISO 9001:2015cGMP manufactureLot-to-lot consistency
FAQs

Therapeutic antibody ELISA FAQs

What can therapeutic antibody ELISA kits be used for?

Free-drug kits quantify a biologic in serum or plasma for QC, biosimilarity and PK studies; ADA kits detect anti-drug antibodies for immunogenicity assessment. All kits are for research use only.

Do you offer free-drug and total ADA formats?

Yes — qualitative, quantitative and free/total ADA formats are available. Free/total ADA kits use acid dissociation to break drug–ADA complexes so both free and complexed ADA can be measured.

How sensitive are the kits and how much sample do they need?

Detection is in the ng/mL range with recovery of 85–115%, typically using under 25 µL of sample and completing in 70–140 minutes.

Which biologics are covered?

More than 30 therapeutic antibodies and biosimilars across anti-TNF, oncology, checkpoint inhibitor, anti-inflammatory, wet AMD and allergy drugs — including adalimumab, infliximab, trastuzumab, bevacizumab, rituximab, pembrolizumab, nivolumab and tocilizumab. Browse the full range in the product listing below.

Can you develop a custom drug-monitoring ELISA?

Yes. If your biologic isn't listed, our PhD-level team can develop a custom free-drug or ADA ELISA — get in touch.

Therapeutic Antibodies & Biosimilar ELISA Kits Product listing