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Eurofins Bioanalytical Services introduces GLP-compliant Singulex® Erenna® services

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The Singulex Erenna immunoassay system detects protein at the femtogram / mL levels, enabling the measurement of ultra-low levels of high value markers. The platform is used in pharmacokinetic studies, to measure biomarkers, and evaluate the immune response to administered large molecule therapeutics- especially where detection levels are a challenge.

Research and regulated assays

Eurofins Bioanalytical Services provides custom assay development, assay transfer of existing methods and validation according to the needs of the needs of the study, from exploratory to full-GLP.

Additionally, services are also provided using the existing biomarker assay kits available from Singulex.

Sample analysis

Transfer and optimization of qualified or fully-validated assays to client specifications

Method Development

Develop assays from scratch or adaptation of the commercially available assays from Singulex

Validation

Validation of analytical methods is crucial in generating data to be used in support of regulatory submissions. Following the most up-to-date industry guidelines, we offer a fully consultative and comprehensive assay validation or cross-validation service. We validate using a fit-for-purpose approach as appropriate for the nature of the assay as well as the stage in drug development.

Sample Analysis

From a single plate to Phase III clinical trial projects, we are equipped to handle variable sample numbers and large volumes to meet the needs of our clients using custom-developed assays or the commercially available assays from Singulex.

Digital Immunoassay Quantification of Low Abundance Proteins

  • 1000 times greater sensitivity than conventional immunoassays
  • PCR-like limits of detection
Broad Dynamic Range
  • Digital detection: accurate counts at the lower end
  • Analog detection: accurate counts at the upper end

Flexibility

  • Standard Kits or Develop Custom Assays
  • Microparticle- or  Microplate-based depending on sensitivity needs