At Smithers, we bring scientific rigor and regulatory fluency to immunogenicity testing. Our proven approach helps you uncover the full picture of anti-drug antibody (ADA) formation and neutralizing antibody (NAb) activity across every phase of development from early discovery to post-market.
We understand that assessing immunogenicity is fundamental to ensuring the safety and efficacy of large molecule therapeutics. Our experts bring decades of experience designing, developing, and validating anti-drug antibody (ADA) assays that inform critical decision making across the drug development lifecycle. Whether evaluating a monoclonal antibody, biosimilar, gene therapy, or vaccine, our immunogenicity testing approach and deep regulatory alignment help you uncover what matters most: immune responses that could impact therapeutic safety and efficacy.
Smithers offers end-to-end support for immunogenicity assessment, from assay development through to regulatory submission:
We implement a tiered testing approach aligned with FDA and EMA guidelines, ensuring reliable ADA detection and characterization to detect the presence of ADAs in biological samples aligned with FDA and EMA guidelines.
Using both cell-based and cell-free formats, we assess the impact of ADAs on biological activity to support clinical relevance and product safety.
Our team designs and qualifies robust methods that are sensitive, specific, and tailored to the unique attributes of your molecule.
Beyond data generation, we provide scientific context by evaluating factors such as product class, route of administration, and patient population.
Smithers operates GLP-compliant, CLIA-certified laboratories in Gaithersburg, Maryland and Ewing, New Jersey. Our facilities are staffed by scientists with extensive experience in immunogenicity testing, including:
Whether you need screening assays for early-stage programs or fully validated NAb testing for regulatory submissions, Smithers is your trusted partner in immunogenicity.
What is immunogenicity testing and why is it important?
Immunogenicity testing evaluates whether a biologic induces an immune response in the body. These responses, particularly the formation of anti-drug antibodies (ADAs), can impact drug efficacy, safety, and patient outcomes.
What types of molecules does Smithers test for immunogenicity?
We support a wide range of therapeutics, including monoclonal and bi-specific antibodies, biosimilars, vaccines, gene therapies, and CAR-T or TCR therapies.
What platforms do you use for ADA and NAb testing?
Smithers employs ELISA, MSD, Gyrolab, EnVision, Quanterix, and other ligand-binding and cell-based assay platforms. Each method is tailored to the specific characteristics of the molecule and the study requirements.
Can you support comparative immunogenicity for biosimilars?
Yes. We offer tailored studies to compare the immunogenicity profiles of biosimilars and their reference products in compliance with global regulatory expectations.
Are your immunogenicity studies regulatory compliant?
Yes. Our labs are GLP-compliant and CLIA-certified. All studies are conducted following FDA, EMA, and ICH bioanalytical method validation guidelines.
Can you develop and validate custom assays?
Yes. Our method development is a differentiator offering bespoke assay development for novel modalities and complex matrices.