Better Data to Drive Drug Development
Drug development is a long, expensive and risky process. Of 250 compounds entering preclinical testing, 10 will enter clinical trials, but only 1 will be approved. Since the 1990s more than half of new drug applications failed due to unpredicted toxicity effects. This trend is expected to continue as the pharmaceutical industry and regulatory agencies shift the risk-to-benefit ratio toward increasing emphasis on drug safety.
Cellumen, a division of Apredica, developed a Cellular Systems Biology (CSB™) approach to give biopharmaceutical researchers the means to screen compounds for broad-ranging toxic effects early in the drug discovery process using tissue-specific cell models. CellCiphr® Toxicity Profiling uses a combination of toxicity-relevant cells and toxicity biomarkers to illuminate cellular system responses to toxic challenges in a specially designed set of CellCiphr Toxicity Panels. These panels are selected to monitor the effects of test compounds on many cellular systems responses known to be correlated with toxic challenge, such as oxidative stress, organelle function, stress pathway activation, cytoskeletal integrity, cell cycle, and DNA damage. Multiplexed cell-, feature-, time- and concentration-dependent profiles are generated using CellCiphr Profiles. The Classifier Analysis Tool tabulates results including the maximum tolerated dose, AC50 curves, common modes of activity, clusters with similar activity profiles, correlation of profiles to known toxic control profiles, rank order and safety risks for prioritization. The CellCiphr® final Profiling Report is designed to identify toxic liabilities early in the drug discovery process. Contact us to learn more.
The Advantage to Using CellCiphr® Toxicity Profiling
- Cellular Systems Biology approach for deeper knowledge
- True image-based high throughput capability
- Minimal compound requirement (generally less than 2 mg)
- Proprietary data Classifier provides a tool to reliably prioritize compounds early in the development process and to gain insights into mechanisms of action
- HCS read-out allows data re-analysis and re-mining for additional cell by cell and sub-cell population analysis
The CellCiphr® final Profiling Report conveniently summarizes in 2 pages:
- All 33-feature dose-response curves with best curve fit
- All AC50 calculations
- Earliest and most sensitive cell feature responses
- General measurements of toxicity
- Similarity plots and correlations to compounds in a series and to control compounds
- Rank order within a group of defined compounds
- Safety Index with high correlation to in vivo toxicity
CellCiphr® Toxicity Profiling products and services are designed to identify toxic liabilities early in the drug discovery process. Contact us to learn more.