Custom Immunoassays
BioGenes Berlin

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.
 

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.
 

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.

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.

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.