I have been studying Biological Markers (biomarkers) for over 25 years, but last 5 years they have exploded and become a key bioanalytical component to a drug’s success. Biomarkers are used to support drug submissions, but the term can mean a very wide range of things including something as standard as blood pressure to something as complex as 19 color flow cytometry panel.
Bioanalytical Biomarkers are often either for (A.) Exploratory/research purposes and non-regulated or Non-GLP – or – (B.) Secondary and Primary end points traditionally requiring regulation or GLP.
QUESTIONS TO ANSWER ABOUT YOUR BIOMARKER:
- What regulatory requirement is needed?
- How do I efficiently test the numerous (greater than 10) biomarkers that was requested by the team.
- How much volume of sample is needed and general sample logistics. What temp to ship at and store.
At KCAS we have 10 biomarker platforms to perform single biomarker analysis or multiplexing biomarker analysis. We have qualified or validated over 300 biomarkers just this past year covering soluble biomarkers such as cytokines and chemokines to cell based 19 biomarker multiplexing panels by flow cytometry to 20 plex by LC-MS.
At KCAS we have over 90 years of collective cytometry experience, in GLP environments. We have solutions to storage and shipment challenges, and find cost effective ways to batch samples. Start a conversation with our business development team today and let us help you find the “right fit” for your Biomarker needs!