Deep scientific expertise
With more than two decades of specialized experience in pharmacokinetics, immunogenicity, and biomarker testing, our team provides scientific leadership across even the most complex therapeutic modalities.
Immunogenicity
Assay expertise for safer therapies
High‑sensitivity, regulatory‑aligned solutions designed to support confident decision‑making throughout every stage of biopharmaceutical development.
Multiple immunoassay platforms
ELISA, MSD®, Luminex® for cytokine and ADA measurement
Advanced cell-based assays
ELISpot for T‑/B‑cell response characterization, and flow cytometry for CAR‑T cell detection and quantification
qPCR-based gene expression analysis
Assessing immune activation and pathway impact
Assay development & validation
Following rigorous GLP/GCP standards for screening, confirmatory, neutralizing antibody (NAb), and characterization assays
Live cell handling
Including PBMC isolation and cell culture for complex immunology and functional assays
ADAs, NAbs & cell-based immunogenicity
Specialized support, including custom assay development for TAB, CAR‑T, BAT, and more
Your trusted partner for immunogenicity testing
High sensitivity, robust specificity
Advanced assay platforms ensure the accuracy and reliability required to detect ADAs and NAbs – even in the presence of therapeutics and high matrix complexity.
Faster, more predictable timelines
Streamlined processes, integrated technologies, and broad in‑house capabilities shorten study startup and accelerate results delivery.
Custom assay development for novel modalities
From biologics to cell and gene therapies, our team excels in designing and validating fit‑for‑purpose assays for emerging modalities, including CAR‑T and AAV therapies.
Strategic partnership mindset
We don’t just execute assays – we collaborate with sponsors to interpret data, troubleshoot issues, and guide regulatory‑aligned study strategies.
The advantage of partnering with Eurofins BioPharma Services
We deliver the scientific insight, technological depth, and operational excellence needed to derisk development and ensure high‑confidence data for regulatory submissions.
State‑of‑the‑art bioanalytical infrastructure
Our purpose‑built, 11‑acre facility in Lenexa, Kansas, was designed to support increasingly complex clinical trials with optimized workflows, high‑quality sample management, and robust data integrity.
One partner, complete support
Instead of managing multiple vendors, you gain a single, unified partner equipped with broad scientific expertise and diverse analytical platforms. This streamlined structure harmonizes processes, improves data continuity, and helps your team move more efficiently from development through clinical execution.
Regulatory‑ready data you can trust
All services are aligned with global regulatory guidance and executed under GLP/GCP frameworks, ensuring reliable, submission‑ready data packages.
Extensive assay portfolio
Access to one of the largest specialized menus in the industry – with over 3,000 immunology and biomarker assays – enables rapid adoption, customization, or development of assays tailored to your therapeutic program.
Exceptional technical breadth
Whether navigating drug/target interference, pre‑existing antibodies, or complex neutralizing assays, our scientists are adept at solving the most challenging immunogenicity issues facing the industry.
Start your immunogenicity journey with confidence
