Ultrasensitive GLP-compliant Singulex® Erenna® Immunoassay Services

By Craig Draper, PhD, Commercial & Marketing Manager, Eurofins Bioanalytical Services, CraigDraper@eurofins.com

Protein biomarkers provide insights into the safety, efficacy and target population during drug development. The successful implementation  of a biomarker strategy provides both time and cost savings, resulting in better medicines available in the clinic faster.  Typically, protein biomarkers are detected in blood or other bodily fluids using a combination of techniques and technologies called Ligand Binding Assays (LBA).

Current generation LBAs routinely detect proteins down to the 1-10 pg / mL range. For years, this level of sensitivity has limited the biomarkers that can be used during drug development to those that had a concentration above this technologicalsensitivity barrier. This inability to routinely and robustly measure biomarker levels below the pg / mL range results in valuableprotein biomarker  signatures going undetected and unused.

Recently introduced advanced instrumentation has improved the sensitivity of protein biomarker assays, enabling the detection of protein biomarkers well below the pg / mL levels. The Singulex® Erenna® platform uses a digital ELISA  approach that is able to detect proteins as low as the femtogram / mL levels, a 1000 fold improvement in sensitivity over existing approaches.  The system uses a well-established assay reagent format coupled with the Erenna instrument that employs single photon digital capture of the assay signal to achieve the ultra-sensitive levels of detection. In addition to performing assay services using commercially available kits for key biomarkers, Eurofins Bioanalytical Services develops and validates custom immunoassays on the Erenna platform, extending the application of the system beyond biomarkers to use in pharmacokinetic studies and also in the evaluation of the immune response to large molecule therapeutics, especially where detection levels are a challenge. The system can be used for exploratory studies or methods can be validated for GLP compliance.

For more information on large molecule bioanalysis, biomarkers and biosimilars, visit www.eurofins.com/bioanalyticalservices.