Custom Biomarker Solutions for Every Stage of Development
Our scientists leverage advanced ligand binding assay (LBA) platforms to develop customized biomarker assays tailored to your study. Using BioTek® Synergy™ microplate readers, we support absorbance, luminescence, and fluorescence applications. Our multiplexing expertise is powered by MSD® (including the S 600™ and QuickPlex® SQ 120) and the Luminex® 200™, enabling sensitive, high-throughput electrochemiluminescence and simultaneous detection of over 30 analytes. We also offer ELISpot and flow cytometry for single-cell biomarker analysis.
With over 30 state-of-the-art mass spectrometers, our LC-MS scientists provide high-resolution, accurate mass analysis for complex biomarker quantification. We apply hybrid extraction workflows and LC-MS detection to support protein biomarker determination with precision and speed, enhancing data quality across discovery and regulated studies.
Regulatory Guidance
The focus on biomarkers in aiding drug development is evident from the emphasis most regulators place on them due to their role in translational medicine. The FDA has a Biomarker Qualification Program for sponsors interested in developing biomarkers.
However, not all sponsors include biomarkers as a consideration early in the drug development process. Focusing on the' benefits of biomarkers in preclinical studies is beneficial to maximize the' benefits of biomarkers. This is the ideal time to determine which biomarkers can help establish efficacy and whether other biomarkers must be included to monitor safety as the drug progresses.
Biomarker bioanalysis can be more complex than measuring the drug since they are often complex proteins present endogenously. Working with a bioanalytical team with experience designing fit-for-purpose assays is key. The Altasciences approach has the added benefit of bringing in toxicologists and clinical pharmacologists to develop a comprehensive preclinical-to-clinical approach to maximize the translation of the results.
View our validated bioanalytical assay list and translational biomarker assays .
Looking to conduct a study? View this list of biomarker assays and contact us to discuss further.