MERCORD3936 small

Immunogenicity Testing

Development and validation of Anti-Drug Antibody (ADA) assays for screening, confirmation and titer, and Neutralizing Antibody (NAb) assays.

immunogenicity testing services

Anti-drug Antibody (ADA) Assays

Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to the production of anti-drug antibodies (ADAs). ADA assays are designed to detect and quantify antibodies produced by patients in response to the administered drug. These assays help identify if a drug is immunogenic and if patients are developing antibodies that may impact drug efficacy and safety. Understanding immunogenicity helps researchers and clinicians make informed decisions about dosing regimens, patient management, and risk mitigation strategies. Mercodia has a proven track record in developing and validating assays for the detection of ADAs. We are GLP approved and work in accordance with regulatory guidelines, ICH GCP, EMA, and FDA.

MERCORD3339
Antibody molecule

Our immunogenicity services

  • Development and Validation of ADA screening, confirmation, and characterization assays.
  • Characterization of ADA in Titre and Neutralizing assays.
  • Cross-reactivity to endogenous counterparts, isotype, and epitope specificity could be evaluated if needed.
  • Statistical Cut point calculations
  • Production of reagents and buffers
  • Life cycle management of the assays
  • Sample analysis

contact us today for a project proposal

Andreas e1670853120827

Andreas Almlén

Key Account Manager Distributors and OEM

(+46) 70 780 95 09 BOOK A MEETING

ASK A QUESTION OR BOOK A MEETING?
WE WILL HELP YOU

Andreas Almlén

Key Account Manager Distributors and OEM

(+46) 70 780 95 09 BOOK A MEETING