There are certain regulations that have to be considered for bioanalytical assays like immunoassays for clinical and pre-clinical pharma-studies. Regulatory requirements for pharma-immunoassays have become more and more demanding over the last years. There is no other area of application of immunoassays where there are such high requirements on analytical quality and reliability.
Relevant guidelines are i.e. the “Guideline on Validation of Bioanalytical Methods” (2011) of the European Medicines Agency (EMA) which came into effect on February 1st 2012 and the “Guidance for Industry – Bioanalytical Method Validation” (2001) from the U.S. Department of Health and Human Services Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM) as well as the following application documents for this guidance.
Both regulations set a high value on avoiding interferences, on very low coefficients of variations as well as on stability of the reagents. These are exactly the core competencies of CANDOR Bioscience. Our team is the global technological market leader in these aspects for more than a decade. Therefore CANDOR is trusted supplier to bioanalytical departments of most worldwide leading pharmaceutical companies.
CANDOR has many years of experience in the development and optimization of challenging assays with highest requirements for analytical reliability and sensitivity. Aspects like robustness against matrix effects and interferences as well as storage stability of assay components like antibodies, conjugates and standards are the core-capabilities of the technical team of CANDOR for many years. The solutions of CANDOR are useful tools for different assay platforms like ELISA, Luminex assays and others.
We offer a fast and uncomplicated consultancy for the development and optimization of assays for pharma research. In short feasibility studies we are glad to demonstrate the potential of further optimization steps. Often this consultancy can show approaches to solving challenges, whilst further steps of development can be executed in your very own laboratories. At any point of a cooperation with CANDOR, the sponsor keeps the assay in-house which guarantees full control and compliant documentation. This leads to the positive aspect, that there are no gaps in the documentation according to the guideline, even if some test-measurements for very challenging assays have been preliminary done at the CANDOR laboratories. Since many years the head of development at CANDOR, Dr. Peter Rauch, instructs assay developers and users in professional in-house trainings in leading German pharma companies and at Contract Research Organizations (CRO’s).
CANDOR does not run GLP-accredited laboratories and does not perform own development and validation-projects for pharma assays. Therefore CANDOR is not a classical CRO for the pharmaceutical industry.
Touch base with our qualified team for every technical challenge which refers to analytical quality and reliability of your immunoassays in every step starting from lead-development to pre-clinical and up to clinical phase.