Non-clinical (or often referred to as preclinical studies) non GLP samples are often used for biomarker and pd (pharmacodynamics) assessments for drug development. In the case of ex vivo therapies and orphan diseases, they are critical to the development of the drug as they are often used to help with the evolution of the mechanism of action in clinical trials.

Investing in non-clinical non glp sample analysis for discovery pharmaceuticals is nothing new, however, the demand for screening of biopharmaceutical drug candidates is increasing. Typically this has been a beneficial approach to perform PK assessments, but we at KCAS offer much more. We can screen non-clinical non GLP samples for biomarkers or PD markers, and in the case of biologics, assess the immunogenicity risk. A GLP method is often not needed and KCAS offers research grade 1-3 method development to assist with support of non-clinical non GLP samples.


We can utilize our expertise and experience to consult with clients on the level of development needed, help strategize which biomarkers to test and best platform to use, and assist with complex PD biomarker assays such as enzyme activity and cell based methods.










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