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.


News archive

Featured products

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™


T Cell Monitoring with PBMC Samples


CTL's cryopreserved peripheral blood mononuclear cells (PBMCs) are ideally suited for T cell monitoring in ELISPOT and ELISA assays, cytokine bead arrays, tetramer and pentamer staining, cytokine capture assays, and any assays that require live PBMCs.

These human PBMC samples are isolated from leukopacks and frozen in CTL-CryoABC™ serum-free freezing medium. These leukopacks are ethically collected from healthy donors with no risk of breaching privacy. Tested for: HBsAg, HBcAb, HCV, HTLV I/II and STS by serology; as well as HIV I, HCV and WNV by NAT (nucleic acid testing).

CTL’s Cryopreserved PBMC are characterized for:

• HLA-type low/high resolution for three Class I loci (A,B,C) and four Class II loci (DRB1, DQA1, DQB1, and DP)

• Cytokine responses to:

o 32 Class I individual CEF-peptides

o 24 Class II individual CEF-peptides

o 2 Class I CEF-Peptide Pools

o 1 Class II CEF-Peptide Pool

o 6 Protein antigens

Mosquito

Dust Mite

Mumps

Candida

PPD

PHA

• Donor Age, Gender, and Ethnicity

• Vaccination status for Vaccinia (Small Pox), Tuberculosis, and Hepatitis B

 

View CTL's Cryopreserved PBMC Frequently Asked Questions

Download CTL's Cryopreserved PBMC characterization info sheet and/or MSDS/PDS

Download CTL's Cryopreserved PBMC poster for information on CTL's cryopreserved PBMC viability.