Bioanalysis of Biologics and Biosimilars

In biological substances coming from preclinical and clinical studies, we have a long track record in development and validation of bioanalytical methods from scratch or working with transferred methods. In addition we have a high capacity of sample processing. For the determination of plasma or serum levels of biologics for PK calculations, we mostly work with immunology methods such as ELISA, ECLA or RIA, but we also have experience in mass spectrometry of large molecules.

We are fully compliance with the EMA guideline on Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins and other regulations and guidelines of the FDA. Our experience covers a wide range of different kind of large molecules:

  • Hormones
  • Biosimilars: proteins and monoclonal antibodiesresizedimage300198-SECTORImager2400A.png
  • Innovative proteins and monoclonal antibodies
  • Antibodies drug conjugates
  • Therapeutic peptides: innovative, generic and hybrid formulations
  • Polysaccharides

Our immunology platform have different technologies available to cover the whole range of needs:

  • ECLA: electrochemiluminiscence using MesoScale Discovery instrument
  • ELISA: direct, sandwich, bridge, competitive using different detection techniques (colorimetric, fluorescence, time resolved fluorescence, luminiscence).
  • RIA: radioimmunoassay testing using I125 

Our mass spec platform counts with 8 LC-MS instruments with different ranges of sensitivity. The strategy to quantify large molecules by mass spec consists on a tryptic digestion of the protein followed by the measurement of the main peptides.

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