Bioanalytical services

Quality Assistance offers a wide range of solutions for the analysis of biological samples. Our bioanalytical services include:

  • pharmacokinetics and toxicokinetics studies

  • immunogenicity assessment

  • biomarker studies

We offer customised testing following either bioanalytical methods transferred to our laboratories or developed and validated by Quality Assistance for the study of biologics (ADCs, mAbs, proteins), small molecules (NCEs) and nanomedicine products.

Thanks to our thorough regulatory, scientific and technical monitoring and skilled teams, we commit to providing the highest quality services and to generating reliable data in order to meet the necessary requirements.

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Bionalysis

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Our expertise

Extensive experience with:

  • Bioanalytical methods

  • PK/TK studies

  • GLP supportive analysis in formulation

  • Immunogenicity assessment

  • Anti-Drug Antibodies (ADAs)

  • Neutralising Antibody Assays

  • Biomarker studies

  • Multi-elemental bioanalysis by ICP-MS

  • Ability to handle cytotoxic compounds and radiolabelled samples

For all matrices

  • Whole blood, plasma, serum, urine

  • Tissues

  • Tumors

  • Vehicles

  • Buffers