ELISA-Entwicklung GmbH & Co. KG

            Deutsch        English                     Home        Service        Contact        Links        Company        Publications

     Range of Services
     Assay Development
     Assay Validation
     Sample Measurement
     Protein Purification
     Antibody Production
     Anti Drug Antibody, ADA



Immunogenicity ELISA (Anti Drug Antibody, ADA)

During drug development the main question beside effectiveness is, if the drug induces antibody formation, which may exclude repeated or long-term treatment. Therefore test systems are needed to document or exclude these undesirable immunological side effects.
Requirements for the development of an ELISA:
-  Masking of potential epitopes due to conjugate synthesis. At least two different types of conjugates are
-  The assay should be species-independent for the use in humans as well as in laboratory animals.
-  Positive antibody results should be confirmed by the addition of the drug to exclude a non-specifity in the test

Means to increase sensitivity

  • An improvement of the assay sensitivity is achieved by the use of a mix of two types of conjugate linking sites: N-terminal via cysteine and C-terminal via lysine,
  • The use of optimal test conditions (time, temperature, buffer)

Principle of a HS sandwich ELISA

Test characteristics

  • Variation of calibration parameters of the 4 parameters logistic (4PL) fit
  • >li>Accuracy and precision results of standards and QC samples
  • Positive and negative controls
  • Cut point factor (CPF) determination
  • Analyte stability
  • Cross reactivity, plate and conjugate interferences
  • Confirmation assay

Optional established methods supporting an HS ELISA development

  • Assay development, validation, documentation and test kit production
  • Technologietransfer und Anpassung des Tests an das Kundenlabor inklusive Training des Laborpersonals.
  • Technology transfer and adaptation at a customer lab including training of the responsible persons