In drug development, monitoring levels of specific molecular biomarkers can help researchers gain a better understanding of the effectiveness of a therapeutic, whether it is a small molecule drug or a biologic.
The increase or decrease in the level of a given biomarker may indicate a particular disease state or correlate with the risk or progression of a disease, allowing patients to be treated earlier for improved outcomes. Certain biomarkers are also able to help identify which treatments a disease would be most susceptible to, improving the overall effectiveness of treatment.

When an organ, tissue, or cell is treated with a therapeutic drug, it activates a specific signal transduction pathway in which a chemical or physical signal is transmitted through a cell as a series of molecular events, most commonly protein phosphorylation catalyzed by protein kinases, which ultimately results in a cellular response. The proteins responsible for detecting stimuli are generally termed receptors. The changes elicited by ligand binding in a receptor give rise to a signaling cascade, which is a chain of biochemical events along a signaling pathway. When signaling pathways interact with one another, they form networks, which allow cellular responses to be coordinated. At the molecular level, such responses include changes in the transcription or translation of genes, and post-translational and conformational changes in proteins, as well as changes in their location. These molecular events are the basic mechanisms controlling cell growth, proliferation, metabolism, and many other processes. Understanding signaling networks may enable prediction of disease mechanisms or responses to therapeutic strategies.

Biomarkers produced during these processes are helpful during the small molecule drug development process as well as for biologics development. A reputable CRO partner will be able to extract meaningful data from measuring various intracellular, membrane-bound, and secreted circulating biomarkers to inform the development process.

biomarker testing for small and large molecule drugs

Circulating Biomarkers
At BioAgilytix, we recognize the importance of measuring circulating biomarkers, as numerous innovative studies across the industry are examining their efficacy as a diagnostic tool for many types of cancer. In our laboratories in the USA and Germany, we have a variety of bioanalytical platforms ideal for the measurement of soluble circulating biomarkers, including ELISA, MSD-ECL, DELFIA, Ella, Luminex, Sword, and Gyros. Not only can we use these platforms to measure the circulating biomarkers in plasma or serum, but we also have the capability and experience to measure soluble biomarkers in other bodily fluids including CSF, synovial fluid, and bronchial lavage, among others.

Intracellular Biomarkers
Intracellular biomarkers are critical in understanding and identifying disease. To measure intracellular biomarkers, BioAgilytix’s scientists either stain and permeabilize the whole cells and then use FACs analysis, or first break the cells open using physical force like sonication or by using various chemical treatments such as detergents. Once the cells are broken open, we can then centrifuge and separate the soluble fractions from the particulates or use the unfractionated lysates. After sample preparation, any one of our immunoassay platforms can be used to measure the biomarker level, including ELISA, MSD-ECL, DELFIA, Ella, Luminex, Sword, and Gyros.

Membrane-bound Biomarkers
Cell surface membrane proteins have the capacity to act as highly targeted and personalized biomarkers, and BioAgilytix scientists have a significant amount of experience with the two approaches to measure such biomarkers. We either stain the whole cell and then perform FACs analysis, or we first solubilize the membrane-bound biomarkers with a detergent before using one of our immunoassay platforms to measure the biomarker level. These platforms include ELISA, MSD-ECL, DELFIA, Ella, Luminex, Sword, and Gyros. FACS analysis also provides the capability of analyzing membrane-bound biomarkers and key intracellular biomarkers in combination within specific cell populations.

BioAgilytix’s Biomarker Expertise
BioAgilytix’s scientists have decades of combined experience providing expert biomarker services and have worked with over 500 analytes in singleplex and multiplex formats across a wide range of disease areas. We are able to leverage our comprehensive menu of validated biomarker assays and/or collaborate with customers on novel biomarker assay development and validation in support of large or small molecule projects.