SERVICES BY PRODUCT TYPE

Immunogenicity assays

Citoxlab – The one-stop CRO for monoclonals and biologicals

> Tissue cross reactivity

> Non-human primate toxicology

> Immunogenicity assays

> Bioanalysis of peptides and proteins

Assessment of the immunogenicity of therapeutic proteins during preclinical studies is performed routinely as part of the evaluation of product safety and efficacy. To ensure consistent evaluation, the development and validation of this type of assay needs to be reliable and sensitive.

Citoxlab has a long experience in the development of validated immunogenicity assays for the quantification of antidrug antibody (ADA) responses. A custom built laboratory at our Atlanbio site performs cell-based assays for the determination of ADA neutralizing properties.

Immunogenicity assay validation key points

  • Cut off determination
  • Minimum required dilution (MRD)
  • Drug interference
  • Matrix effect
  • Within- and between-series precision/accuracy
  • ADA stability

ADA assay (ELISA)

  • Screening assay
  • Confirmation assay (depletion)
  • Titration assay