Commercial kit-production for human- and veterinary diagnostics, for food diagnostics and more and more for environmental analytics and research assays are subject to high regulatory requirements. Assays have to be optimized in consideration of their reliability, limit of detection and robustness against matrix effects and interferences. The stability of the kit-components is very important as a reduced activity after storage of the conjugates negatively influences robustness and limit of detection of assays.
Our experienced team supports commercial manufacturers of kits with feasibility studies and consultancy for the optimization of assays in the stated application areas. It is always taken care of the regulatory requirements like the IVD-Regulatory (European Directive 98/79EG about in-vitro-diagnostics) or further applicable standards or regulations.
CANDOR stands by your side as a flexible and competent partner for development and optimization projects. First feasibility studies at CANDOR are mostly done free of costs and in a very short time frame, so that the kit-producer can get an impression about potentials of the optimization and revision of existing immunodiagnostics quickly. This reduces your risk and shortens the time-to-market of new and improved immunodiagnostics.
CANDOR does not carry out complete development projects according to regulations and does no development documentation or validation on its own. This remains your full responsibility as a kit producer. This means that all important decisions as well as the full control about your projects, the documentation and the approval of the final kits are finalized without any interface to CANDOR and are therefore your own responsibility. We are always available if needed but will not interfere to your processes, core capabilities and expertise as kit-producer.
CANDOR does neither develop nor produce or sell any own IVD’s (in-vitro diagnostics). CANDOR is not a competitor to IVD producers and distributors.