Biomarker is a broad term and can mean so many different things depending upon the scientific discipline. For Bioanalytical biomarker analysis – and specifically for CROs equipped with 9 different platforms to measure biomarkers and a cell culture suite with up to 19 color flow cytometry all under one roof like we currently have at KCAS – that covers a lot of drug development. Perhaps one could argue it potentially covers all of drug development, seeing how we have experts in LBA, LC-MS/MS, hybrid LC-MS/MS (or affinity capture + LC-MS/MS), and cell based assays.
Frequently, we are asked to help with identification of clinically validated biomarkers for support of drug development meaning they have been shown to be validated biologically in patients as relevant for the disease or disorder. The language used here has nothing to do with the bioanalytical validation of a given biomarker method. We at KCAS take a multi-level approach to how we validate biomarker assays. The most stringent form is a GLP validation which requires months or perhaps years to perform. More common is a non-regulated fit-for purpose validation (or often referred to as a non-GLP Qualification). What is personally frustrating is how many non-regulated fit-for purpose validations we perform annually but can’t share with anyone. Fortunately, we at KCAS counteract that issue by routinely offering value to our clients by spending our R&D dollars on non-regulated fit-for purpose validation of clinically validated biomarkers.
At KCAS, we recently completed a non-regulated fit-for-purpose validation of a TH-17 25-plex using the Luminex platform. This panel of clinically validated biomarkers allows our clients to test either the entire panel or a single analyte without the need to invest a single penny on method development or method qualification. This also makes a perfect starting point for a quick feasibility test to confirm the method in your specific sample matrix. We have over 100 additional biomarkers that we have validated using LBA platforms and LC-MS/MS. Additionally, we have 16 flow cytometry panels containing over 50 unique Biomarkers. If you have not used KCAS for biomarker analysis, we would be happy to consult with you on the regulatory requirements, the level of validation needed, and how to do it on time and on budget without compromising the quality of the data.