Are you a bioanalytical lab struggling with the difficult choice between regulatory compliance and operational flexibility? Immunogenicity testing and anti-drug antibody (ADA) workflows are critical in biopharmaceutical development. ADA assays detect immune responses against therapeutic biologics, which can impact safety and reduce drug efficacy. Precise screening, confirmatory, titer, and neutralizing antibody (NAb) assays are essential for reliable results.
Bioanalytical labs face a common challenge: systems that enforce compliance often limit flexibility, while platforms designed for flexibility may fall short on regulatory requirements.
LabWare solves this challenge by uniting compliance and flexibility in one enterprise-proven bioanalytical platform.
Immunogenicity and ADA Testing with LabWare
- Screening assays to detect anti-drug antibodies in patient samples.
- Confirmatory assays to verify the specificity of immune responses.
- Titer assays to measure antibody levels with reproducible precision.
- NAb assays to evaluate if antibodies block drug activity and alter clinical outcomes.
All of these workflows are managed in LabWare’s Bioanalytical Solution, providing labs with a unified environment rather than a collection of disconnected systems.
Compliance Without Compromise
- Built-in validation tools to meet regulatory bioanalytical method requirements.
- Automated audit trails and complete traceability of samples, reagents, and instruments.
- Reproducibility and cut-point analysis across inter- and intra-run data for regulatory confidence.
With LabWare, immunogenicity and ADA studies are always regulatory-ready.
Flexibility for Scientists
- Configurable ADA workflows tailored to each lab's needs.
- Microtiter plate management and exception handling.
- Direct instrument integrations to reduce manual effort and errors.
Scientists gain more time for science, with fewer bottlenecks in daily ADA and NAb testing.
Unified ADA Platform
LabWare combines compliance features (with configurable workflows) with enterprise scalability that competitors lack. One system covers:
- ADA assays (screening, confirmatory, titration, NAb)
- Immunogenicity workflows
- Critical reagent management
- Advanced analytics for cut-point determination
Learn How LabWare Can Transform Your Bioanalytical Lab
Contact LabWare today to learn how our platform supports immunogenicity and ADA testing at scale.
Frequently Asked Questions
What is an ADA assay?
An ADA assay detects immune responses against therapeutic biologics. ADA assays include screening, confirmatory, titer, and NAb tests to ensure drug safety and efficacy.
Why is immunogenicity testing important?
Immunogenicity testing measures whether a biologic drug triggers an unwanted immune response. These responses can reduce effectiveness or cause safety risks. Regulators such as the CDSCO, EMA, and FDA require robust immunogenicity assessments in drug development.
What is a NAb assay?
Neutralizing antibody assays determine whether antibodies detected block the intended biological activity of a drug. NAb testing is critical because neutralizing responses directly affect drug performance and patient outcomes.
How does LabWare support ADA and immunogenicity workflows?
LabWare provides a unified platform (LIMS + ELN + analytics) to manage ADA assays, immunogenicity workflows, and critical reagents. Built-in validation, automated audit trails, and advanced analytics ensure both compliance and flexibility.
How does LabWare handle cut-point analysis?
A cut-point is a threshold signal value that distinguishes between positive and negative samples—i.e., whether a sample contains ADAs or not. Because biological data is inherently noisy, LabWare can define this threshold value per sequence run and analyte in method validation parameter statistical analysis.
How does LabWare help with regulatory compliance in ADA testing?
LabWare provides a unified platform (LIMS + ELN + analytics) to manage every aspect of ADA assays, immunogenicity workflows, and critical reagents. Our built-in validation, automated audit trails, and advanced analytics ensure both compliance and flexibility.
What makes LabWare’s Bioanalytical Solution different from other LIMS?
Some commercial purpose-built bioanalytical LIMS emphasize compliance but lack flexibility, and do not include ELN. Other LIMS emphasize flexibility but have no proven regulatory industry track records. LabWare uniquely combines multiple strengths: absolute confidence in compliance, built-in bioanalytical workflows with unmatched flexibility, and enterprise-level scalability.
