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 History


Cellular Technology Ltd. was formed in 1998 by Dr. Paul V. Lehmann, a Professor at the Case Western Reserve University School of Medicine.

Dr. Lehmann is a leader in the field of T cell immunology with over 20 high ranking publications dedicated to establishing the scientific basis of cytokine ELISPOT analysis.

Dr. Lehmann developed the original ImmunoSpot technology in order to conduct his own research more effectively. The ImmunoSpot platform is the most frequently referenced in the scientific literature in this field and is widely accepted to be the gold standard.  Applications of ImmunoSpot technology include diagnosis and drug discovery for infectious diseases such as HIV and tuberculosis, better understanding and treatment of allergies and autoimmunity, the ability to predict rejection/acceptance responses in organ transplantation and significant improvements in vaccine development and monitoring including for various cancers where post treatment monitoring will be a key part of the therapy.

Dr. Lehmann pioneered the development of tools to accurately and reproducibly measure T cell responses. Dr. Lehmann and CTL designed and constructed the world’s very first ELISPOT reader under US Patent No: 6,410,252 (Methods for Measuring T Cell Cytokines, issued June 25, 2002). The company has been at the forefront of this field ever since.

In 2001, CTL established a laboratory to provide assay services to companies and academic researchers involved in cellular immunology research, drug discovery and drug development.  These services include immunogenicity testing, plate scanning and analysis, and ELISPOT assay training.

Within recent years, CTL has expanded its platform to include additional products and services for those in the scientific community.  These include cryopreserved PBMC, serum-free media, plaque and colony counters, and expanded contract research services.  

Headquartered in Cleveland, Ohio, CTL has expanded to include offices in China, Germany, and Japan.