04/03/2009 11:36

CTL Writes Book Chapter on Validating Reference Samples for Use in Cell-Based Assays

In a new book on cell-based assays, CTL discusses key considerations in validating an ELISPOT assay.

Cellular Technology Limited has contributed a key chapter to the book, Validation of Cell-Based Assays in the GLP Setting: A Practical Guide. This text is one of the latest offerings by Research and Markets, a leading source for international market research and market data.

This book describes the development, optimization and validation of various cell-based assays, such as cytokine ELISPOT and ELISA assays, for which validation procedures have been developed. In addition, it discusses the validation of these assays for select targets using step-by-step instructions. Chapter 9 ("Validating reference samples for comparison in a regulated ELISPOT assay") was written by CTL personnel Magdalena Tary-Lehmann, Christina D. Hamm, and Paul V. Lehmann. In this chapter, they discuss the utility and performance of the ELISPOT method, as well as key considerations in validating such assays.

Validation of Cell-based Assays in the GLP Setting is an invaluable reference source for pharmaceutical companies and biotechnology firms that need to evaluate drug targets derived from genomics and proteomics. It is also a useful reference for companies that use cell-based technologies for biomarker discovery and development.

In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development.

 

For more information visit www.researchandmarkets.com/reports/c89231.


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ELISPOT assays


The ELISPOT assay is the most sensitive technique available for the detection of immune cells which secrete specific signature proteins such as antibodies or cytokines. It therefore represents the state-of-the-art for the detection, measurement and functional analysis of immune cells.

Why ELISPOT?

Accurate ex vivo frequency measurements down to the one-in-one million cell range. This resolution is orders of magnitude higher than that reached via intra-cellular cytokine, tetramer staining or ELISA measurements. Such added sensitivity is critical since antigen-specific T cells typically occur in low frequencies in vivo.

High-throughput T cell analysis becomes feasible. A trained team in a reference laboratory can test hundreds of samples for reactivity to dozens of antigens.

Fewer cells are required compared to other cellular assays. Only 45 ml of blood is needed for testing reactivity to 600 different antigens/peptides.

Determinants targeted by CD4 or CD8 cells can be defined. Because relatively few cells are needed and because the assay can be performed in high-throughput mode, our ELISPOT assays are ideal for screening peptide libraries for determinant mapping.

Cryopreserved human lymphocytes can be tested without loss of function. Pre- and post-treatment samples can be tested side-by-side with highly reproducible results.

CTL’s founding scientists take pride in having established the technical and scientific foundations of cytokine ELISPOT analysis (see peer reviewed reference list). 

We have elevated ELISPOT to an exact science, transforming it to the robust and validated T cell diagnostic tool it is today. We would like to share this expertise with you.

 

Want to learn more?  Please feel free to look at CTL's Frequently Asked Questions list on ELISPOT assays.

ELISPOT assays


Why CTL

Why ELISPOT

ELISPOT vs Other Applications