1. Home

  2. caret-right icon

    Immunoassays

  3. caret-right icon

    Analytical Areas

  4. caret-right icon

    Immunogenicity

Immunogenicity

Immunogenicity assays for confident drug development

Immunogenicity testing plays a critical role in the development and regulatory approval of biopharmaceuticals. Therapeutic proteins, antibodies, and other biologics can trigger immune responses in patients, leading to the formation of anti-drug antibodies (ADAs) that may impact safety, efficacy, and pharmacokinetics.

Our immunogenicity assays are designed to detect and characterize these immune responses with high sensitivity and reliability. By combining robust assay design with advanced automation, we support drug developers in generating reproducible, regulatory-ready data throughout preclinical and clinical development.

Talk to an expert
Immunogenicity

Gyrolab is Ideal for immunogenicity analysis

High-quality immunogenicity data begins with precise and reproducible assays.  With the Gyrolab automated immunoassay platform, we make immunogenicity testing more consistent, precise, and reliable, supporting scientists with the high-quality data needed throughout drug development. The platform’s microfluidic disc technology enables highly controlled assay conditions and precise reagent handling, significantly reducing variability compared with traditional manual immunoassays. Automated processing and standardized workflows ensure that each sample is treated identically, producing reliable results across runs, operators, and study phases. This level of precision supports confident decision-making during drug development while meeting the stringent requirements of regulated bioanalytical environments.

Automation is central to improving assay robustness and data integrity. The Gyrolab platform minimizes manual intervention by automating key assay steps, including sample processing, reagent addition, incubation, and washing. This reduced manual handling helps:

    • Lower operator-to-operator variability
    • Improve assay reproducibility across studies
    • Maintain consistent assay performance in regulated environments

In addition, the platform supports high drug tolerance, enabling accurate detection of anti-drug antibodies even in the presence of circulating therapeutic compounds. The result is reliable immunogenicity data that supports regulatory submissions and long-term development programs.

How it works

1. Sample Preparation
Biological samples, such as serum or plasma, are prepared using validated protocols to ensure stability and compatibility with the assay.

2. Automated Assay Setup
Samples, reagents, and controls are loaded onto the Gyrolab platform. The system automatically performs precise reagent dispensing, incubation, and washing steps within its microfluidic structure.

3. Data Acquisition
The instrument detects binding events and generates high-resolution signal data for each sample with minimal background noise.

4. Data Analysis and Reporting
Advanced software tools process the assay results, enabling rapid interpretation, statistical evaluation, and generation of compliant reports suitable for regulated studies.

Explore Gyrolab generic ADA kit

Multiple antibody-based drug candidates are often evaluated in parallel using a small number of animals. The development of drug-specific ADA assays for each candidate can be impractical. However, a generic ADA assay that detects human IgG in complex with anti-human IgG in preclinical study samples can be used without assay development between drug candidates. Learn more about generic ADA assays for rodent and non-human primate studies on the Gyrolab platform.

Sandwich assays using a drug product capture antibody and labeled drug product for detection are typically used for drug-specific ADA assays for measuring free ADA. Gyrolab ADA Solution (Gyrolab Mixing CD 96 and Rexxip ADA Buffer) automates drug-specific free ADA assays using the Gyrolab Mixing CD 96 for automated or offline acid dissociation which is often required to dissociate immune complexes.

Gyrolab kits & solutions

Gyrolab vs ELISA for immunogenicity analysis

Time to results

Time to results

Results in just over an hour, compared to several hours or overnight with ELISA.

Hands-on time

Hands-on time

Automated processing reduces manual pipetting and intervention.

Dynamic range

Dynamic range

Fewer dilutions are needed to bring samples into range.

Matrix tolerance

Matrix tolerance

The flow-through format reduces background in complex matrices such as serum.

Sample volume

Sample volume

Nanoliter-scale assays require significantly smaller sample volumes than plate-based methods.

Throughput and runs required

Throughput and runs required

Higher pass rates and faster runtimes reduce repeat burden keeping your project timelines on track.

 

Case study

Improving ADA assay repeatability through method optimization

A Gyrolab-based anti-drug antibody (ADA) assay was optimized to address nonspecific interactions affecting repeatability in clinical serum samples. By systematically adjusting assay conditions — including buffer composition, ionic strength, and washing steps - the team identified and resolved the source of variability. Optimizing the neutralization buffer pH and molarity eliminated unwanted interactions and improved both repeatability and drug tolerance. The result was a more robust and reliable ADA assay, supporting immunogenicity assessment and enabling confident progression toward method validation.

Read more

Further reading

Validation and data confidence

Gyrolab is used in bioanalytical preclinical and clinical environments where data integrity, traceability, and reproducibility matter. Automated workflows reduce operator-dependent variation, while software support provides audit trails, controlled user access, and structured data handling to support compliance with GLP/GMP expectations.

Assays can be transferred between systems and sites with reproducible results, supporting long-term studies and regulatory submissions without added complexity.

Scientist woman

Accelerate your immunogenicity testing

Reliable immunogenicity data are essential for advancing biologics safely and efficiently. Our automated assay solutions combine scientific expertise with advanced technology to deliver robust and reproducible results at every stage of development.