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As the use of immunoassays to discover, detect, and quantitate proteins from a variety of biological samples has greatly expanded, so have requirements for enhanced sensitivity, precision, reliability, and ease of assay development.

Recent advances in immunoassay technologies have provided superior sensitivity to measure low-abundance proteins in scarce samples, greatly facilitating scientific advancements in research and clinical settings. In particular, the development of novel systems has allowed quantification of ultra- low concentrations of analytes such as required for low-abundant endogenous biomarkers or when used either in dose-escalation or micro-dosing studies.

In this webinar, scientists developing biomarker immunoassays will describe their adaptation of a traditional ELISA assay to the Research Use Only Erenna® Immunoassay System. The Erenna Immunoassay System utilizes Singulex’s single molecule counting (SMC) technology, combining microparticle and plate-based immunoassays with digital detection. SMC™ technology provides high precision and a high degree of sensitivity, enabling biomarker and bioanalytical measurements across multiple disease and therapeutic areas.

Presenters will also discuss the use of the Erenna Immunoassay System for clinical pharmacokinetic (PK) assay development and validation, enabling measurements where the traditional methodologies of ELISA or ECL offer only limited resolution and sensitivity, particularly for full pharmacokinetic profiling of biopharmaceuticals.

Specific focus area for discussion will include quantification improvements for ELISA Conversion to an Erenna Immunoassay, From Plate to Patient: Development of a Highly Sensitive Clinical PK Assay, and Erenna PK Assay Development and Validation in GLP Environment.

Who Should Attend

  • Biomarker assay developers
  • Immunoassay developers
  • QC/QA scientists
  • Bioprocess development scientists
  • Immunologists
  • Biochemists
  • Drug development scientists
  • Cell biologists
  • Pharmacologists
  • Bioanalytical scientists
  • Translational research scientists
  • Clinical researchers

You Will Learn

  • How to effectively and efficiently convert a standard ELISA assay to the Erenna Immunoassay System.
  • How to approach considerations when choosing between a plate-based or a microparticle-based Erenna immunoassay.
  • How a clinical PK assay can be developed and validated on the Erenna Immunoassay System, including within a GLP laboratory environment.
  • How the Erenna Immunoassay System can accurately, precisely, and reliably quantify low-abundance proteins at femtogram/mL concentrations.
  • How the Erenna Immunoassay System provides sub-picogram sensitivity for analytes in a variety of matrices.
  • How the system can produce biomarker and bioanalytical data that were previously unattainable with conventional immunoassay formats.

Produced with support from:

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Panelists

Andrew Macintyre, M.D., Ph.D.
Director,
Pacific Biomarkers

Sarah E. Christensen
Research Associate II,
Pacific Biomarkers

Phyllis R. Conliffe, Ph.D.
Executive Director,
Smithers Avanza