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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CTL QC Sets™

CTL’s Reference Sample QC Sets™ offer outstanding inter-assay control. Use CTL's QC Sets™ not only for validation and protocol setup purposes, but also as internal controls for clinical trials...

CTL QC Sets™

CTL Reference Sample QC Sets


Reference Sample QC Sets™

CTL Reference Sample QC Sets™ are cryopreserved PBMC samples that have been characterized for IFN-γ production in response to certain viral antigens. Having high-quality reference samples is critical when performing standardized work, especially in a highly regulated environment.

The Reference Sample QC Sets™ have been specifically designed for use in assay validation and in protocol setup. They are also invaluable as internal controls for clinical trials, allowing researchers to use samples from donors with known reactivities to specific peptide antigens. Based on the validation results, the samples can be used to define cutoff values for acceptance of the assay. This makes CTL Reference Sample QC Sets™ a crucial component of assay standardization.

Many applications can benefit from the use of such PBMC reference samples. These include the following:

  • ELISPOT assays
  • Tetramer/Pentamer staining
  • Intracytoplasmic cytokine staining (ICS)
  • Cytokine ELISA assays
  • Cytokine bead arrays (CBA)
  • Cytokine protein arrays (CPA)
  • Cytokine mRNA determinations (RT-PCR)

Each Reference Sample QC Set includes one vial of cyropreserved PBMC that bears a specified HLA allele. Also included are three vials of ready-to-use HLA Class I-restricted peptides: one that elicits a high-frequency response in the IFN-γ producing CD8 cells, one that produces a low frequency response, and one that elicits no response at all.