Immunogenicity

Biopharmaceuticals may elicit an immune response in pre-clinical animal and in clinical studies. An immune response may affect the efficacy of a biopharmaceutical by altering its pharmacokinetics and/or neutralizing its activity. In the worst case, an endogenous counterpart of the drug may be neutralized with disastrous consequences. It is therefore mandatory to monitor immunogenicity adequately during all phases of product development.

BURECO’s TESTING STRATEGY

Immunogenicity testing should be done on the basis of a risk assessment and is usually done in several stages:
  • SCREENING ASSAY that detects all antibodies binding to the biopharmaceutical (ADA; anti-drug antibodies) in serum samples of animals or patients,
  • CONFIRMATORY ASSAY to eliminate false positive samples,
  • ASSAY FOR NEUTRALIZING ANTIBODIES that detects those serum samples that contain neutralizing antibodies, and
  • CHARACTERIZATION of anti-drug antibodies detected in serum samples.
BURECO has extensive experience in developing suitable, project specific immunogenicity testing strategies for pre-clinical as well as for clinical studies.