Comprehensive large molecule capabilities

We deliver end‑to‑end large molecule bioanalysis with deep scientific expertise, advanced assay platforms, and decades of experience supporting biologics programs.

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Dedicated large molecule expertise

We provide specialized large molecule bioanalysis across diverse biological matrices using ELISA and ECL (MSD) platforms, with fit‑for‑purpose method development, qualification, and validation.

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Full portfolio across development stages

Support spans preclinical safety, exploratory programs, and clinical studies through post-marketing surveillance, all conducted under GLP/GCLP‑compliant systems.

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Extensive PK/TK, ADA & NAb capabilities

Comprehensive pharmacokinetic, toxicokinetic, anti‑drug antibody (ADA), and neutralizing antibody (NAb) assays for biologics and biosimilars.

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Method development & validation expertise

In‑house scientific teams design, develop, transfer, and optimize bioanalytical methods tailored for biologics and Context of Use (COU).

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Industry‑leading scale & experience

We are a powerhouse in large molecule bioanalysis, shaped by decades of leadership, industry collaborations, and a dedicated team focused solely on large molecule programs.

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Flexible, client‑centered delivery

Our team adapts to the needs of each program – from exploratory biologics to complex clinical portfolios – bringing scientific insight and operational agility.

 

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Leading technologies & platforms

Our platform diversity enables sensitive, reproducible, and regulatory‑aligned assays for complex biologics:

  • ELISA & ECL (MSD) immunoassays for quantitation and ADA/NAb characterization.

  • Broad assay menu for biotherapeutics: Including antibodies, peptides, recombinant proteins, and other biologics prone to immune response. 

  • Validated large molecule methods: Robust qualification and validation approaches tailored to modality, matrix, and regulatory expectations.

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Scientific presentation

Putting Cell Counting in Context (of use): Analytical Measurements Supporting Cellular Therapies

Explore how context of use influences cell counting and analytical measurements in cell therapy development and clinical evaluation.

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Your proven partner for complex clinical testing needs

From antibodies and recombinant proteins to advanced biologic modalities, we deliver the scientific strength, operational scale, and regulatory alignment needed to move large molecule therapeutics forward.

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Extensive large molecule expertise

Our teams focus on large molecule bioanalysis, offering unmatched depth across ADA monitoring, biologics PK, immunogenicity risk assessment, and biomarker integration.

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Integrated GLP/GCP‑aligned operations

Eurofins Viracor BioPharma has expanded its GLP/GCP bioanalytical capabilities within its purpose‑built, 11‑acre Lenexa facility—offering method development, validation, and regulated sample analysis in one streamlined environment.

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Industry‑leading infrastructure

Our newly expanded, state‑of‑the‑art laboratory space was engineered for high‑quality sample handling, stringent data integrity, and optimized workflows, ensuring reliability across complex clinical trials.

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End‑to‑end bioanalytical support

Integrated laboratory teams, harmonized contracting, and unified technologies reduce operational complexity and create a seamless experience from early development through late‑stage clinical programs.

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Scalable capacity for all program sizes

Whether supporting emerging biotech or late‑stage global trials, Eurofins BioPharma Services provide flexible, high‑capacity resources to meet timelines and quality expectations.

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Regulatory‑ready data

All services are compliant with global regulatory requirements and delivered through robust quality systems – ensuring submission‑ready data packages for biologics.

Experience you can trust

Our scientific and regulatory insight ensures your large molecule program is in expert hands.

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ADCs Right Icon

Robust bioanalysis for ADC PK and immunogenicity, as well as custom biomarker assays for every stage of drug development.

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Biosimilars Right Icon

Trusted biosimilar bioanalysis with proven assays and regulatory insight to support comparability, safety, and efficacy studies.

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Fusion Proteins Right Icon

Comprehensive fusion protein bioanalysis with regulatory expertise to support development from pre-clinical to approval.

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Immunotherapy Right Icon

Expert immunotherapy bioanalysis with validated assays and regulatory support to advance innovative immune-based treatments.

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LBAs Right Icon

Reliable ligand-binding assays for biologics, supporting PK, PD, and immunogenicity with validated, regulatory-compliant methods.

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mAbs Right Icon

Specialized mAb bioanalysis with validated assays and deep expertise to support development, characterization, and regulatory success.