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ELISA Development, Validation and Kit Production

BioGenes is a trusted and experienced immunoassay expert. We provide our clients with assistance and services in ELISA and HCP assay development, validation, optimisation, and kit production. The immunoassays are designed based on microtiter plates or tubes, either as competitive assay for the determination of haptens, or sandwich assay for the determination of proteins.

The customer can order single services or full-service packages, and either the manufacturing of assay components or complete kits.

The services include:

  • Biotinylation of antibodies and search of suitable antibody pairs
  • Testing of cross reactivities against various proteins
  • Optimisation of assay parameters including plate-coating conditions and buffers
  • Determination of analytical assay parameters
  • Production of complete kits or assay components in agreed quality and quantity
  • Stability testing of the kits or assay components
  • Permanent quality control of all components

  Pre-Validation according to ICH guidelines including

  • Demonstration of the assay performance meeting accuracy and precision acceptance criteria
  • Determination of statistical assay parameters
  • Supporting documentation, depending upon the client's requirements

To see more analytical services click here.


Dr. Nicole Gliese
Head of Project Management
+49 (0)30 65762022
Dagmar Schwertner-Knoll
Marketing/Sales Director
+49 (0)30 65762380