Expert biosimilar testing support

We bring decades of experience and deep regulatory insight to biosimilar testing. Our bioanalytical experts specialize in product characterization, PK, and immunogenicity for both originator biologics and biosimilars.

From preclinical through drug surveillance and beyond, we deliver the high‑quality data and scientific guidance needed to advance your biosimilar with confidence.

Comprehensive biosimilar assay capabilities

We support biosimilar development across a wide range of biologic drug classes, including:

  • Monoclonal antibodies

  • Metabolic hormones

  • Immunomodulatory drugs such as Trastuzumab, Bevacizumab, Cetuximab, and Adalimumab

Our tailored bioanalytical and characterization packages are designed to meet the unique requirements of your biosimilar program, in full alignment with FDA and EMA regulatory guidance.

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Advanced technologies & regulatory-ready data

Using the latest instrumentation and validated procedures, we deliver high-quality, reproducible data that meets global regulatory standards. Our capabilities include:

  • Immunogenicity and PK studies

  • Biomarker analysis

  • Cell-based assays

  • Assay development, validation, and transfer

Whether you're developing new assays or transferring existing methods, we ensure accuracy, compliance, and timely delivery of critical data.

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A tailored approach to biosimilar testing

No two biosimilars are alike – and neither are their testing requirements. Our philosophy is rooted in flexibility and scientific rigor. We understand the complexities of biosimilar comparability and offer customized solutions to address your specific challenges.

With extensive experience in biologics and biosimilars, we help you:

  • Design and validate fit-for-purpose assays

  • Navigate regulatory pathways with confidence

  • Generate robust data for comparability and immunogenicity assessments

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