Custom Immunoassays
BioGenes Berlin

BioGenes has a wealth of experience in the development and production of robust and highly sensitive immunoassays for leading pharmaceutical and biotech companies worldwide. The assays can be developed in different formats, like sandwich or competitive assays, and are suitable for various applications, like quality control, drug discovery and diagnostics. Customers can order individual services or full-service packages.



  • Inhouse development and production
  • Polyclonal antibody generation in various species 
  • Monoclonal antibody development including pair search


  • Types of immunoassays: ELISA, CLIA and FIA 
  • Scalability according to your needs
  • Production of assay components or complete kits, starting from 50 kits

Development Strategy

Phase 1 - Expert consultation

We offer customized assay development services that are tailored to your specific requirements. If existing ELISA kits or antibody pairs do not meet your needs for sensitivity, specificity, or cross-reactivity, our experienced team will work closely with you to design a fully customized strategy that is crucial for the success of your project. We believe that there are several effective strategies for developing an assay, and we will collaborate with you to determine the best approach.

Phase 2 - Antigen characterization

The antigen (proteins, peptides, small molecules, modified peptides, drug substances and antibodies itself) will be characterized and/ or modified, if necessary. For antigen preparation several additives in certain concentration are acceptable. Find the requirements here or contact us for further questions.

Phase 3 - Antibody development, characterization and modification

The production of primary antibodies specific for the respective analyte is the most crucial step in custom immunoassay development. BioGenes offers sophisticated monoclonal and polyclonal antibody development which is highly customizable according to the project specifications. 

Polyclonal antibodies are generated in either rabbits, mice, goats or sheep. Our immunization protocols are optimized to ensure high specificity, sensitivity and high titers. Large Scale antibody purification (specific or total IgG) as well as capture and detector antibody preparation are essential parts of the work package 

Monoclonal antibodies (mAb) are developed in mice by hybridoma technology. Our screening procedures are adapted according to the projects aim to in or exclude cross reactivities or for inhibition testing. Depending on the final assay set up pair search and/ or antibody modification are essential parts of the work package. Suitable monoclonal antibodies will be produced in needed amounts for assay development and production.


Phase 4 - Assay development and testing of matrix effects

The assay will be developed in the required type and according to the agreed conditions. Upon assay development, the assay is optimized in terms of accuracy and sensitivity. Testing matrix effects is crucial for successful measurement in real samples. Therefore, the measuring matrix is characterized, the ELISA’s accuracy is tested by spiking experiments and the ELISAs’ precision is evaluated.

Phase 5 - Pre-validation and kit production

We perform pre-validation according to ICH guidelines, ensuring that the assay meets accuracy and precision acceptance criteria. Afterwards, we seek customer approval for pilot production. In case of providing the ELISA method in a kit format, real-time stability testing is conducted. We deliver fully developed and optimized reagents for easy use in your laboratory, and if desired, providing dozens or hundreds of ready-to-use kits, including pre-coated plates and necessary reagents.



For more than 25 years we have successfully developed and qualified custom assays for several purposes e.g., quality control, drug discovery & development, biomarker detection and detection of small molecules.


  • In-house antibody development according to highest animal welfare standards 
  • Production of complete kits or assay components according to the agreed quality and quantity
  • Real-time stability testing of kits or components
  • Detailed documentation of work phases and results


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