Immunogenicity

Robot Zephir red_0.jpgWe develop new bioanalytical methods for immunogenicity studies of proteins and peptides following EMA and FDA guidelines on Immunogenicity of Therapeutic Proteins. Depending on the purpose and the stage of the research project, different studies must be conducted:

  • Determination of Binding Antibodies: screening, confirmatory and titration testing.
  • Neutralizing Antibodies
  • Antibody Typology
  • Cellular Immune Response

A cutting edge equipment is available in KYMOS to perform these services:

  • Immunoassays by ELISA, ECLA and RIA
  • Cell based Assays by fluorescence, luminiscence and flow citometry
  • Surface Plasmon Resonance using Biacore

We offer an added value service covering the full life cycle of research and development, from preclinical studies to clinical phase I to IV. Other related services to facilitate the progress of the project are the following ones:

  • Production of the polyclonal antibodies needed for assay
  • Animal housing management
  • Synthesis, purification and quality control of tracers and radiotracers
  • PK calculations, data analysis and reporting, using Phoenix WinNonlin® software
  • eCTD format, if required

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