Ce in Biotechnology: Practical Applications for Protein and Peptide Analyses

ISBN-13: 9783322830234 / Angielski / Miękka / 2012 / 102 str.

Anthony B. Chen; Kevin D. Altria; Wassim Nashabeh

Opis

The goal of this book is to show recent developments in the CE analysis of protein pharmaceuticals. It is devoted completely to practical concerns to strengthen the use of CE within the biotechnology industry, highlighting the uses of CE in various areas of product development including formulation studies, process development, product characterization and validated lot release and stability testing.

Spis treści

Capillary Electrophoresis in the Development of Recombinant Protein Biopharmaceuticals - Selection of Buffers in Capillary Zone Electrophoresis: Application to Peptide and Protein Analysis - Reverse-Phase High Performance Liquid Chromatography and Capillary Zone Electrophoresis Separation of Protegrin Analogs - Use of Capillary Electrophoresis to Determine the Dilute Protein Concentration in Formulations containing Interfering Excipients - The Effect of Solution Environment on the Resolution of Recombinant Human Deoxyribonuclease Variants in Capillary Zone Electrophoresis - Recent Advances in Capillary Isoelectric Focusing - Separation of Enbrel® (rhuTNFR:Fc) Isoforms by Capillary Isoelectric Focusing - Optimization, Validation, and Use of Capillary Gel Electrophoresis for Quality Control Testing of SynagisÒ, a Monoclonal Antibody - Analysis of Protein Therapeutics by Capillary Electrophoresis - Sensitive and High Resolution CE/MS/MS for Protein Identification in Complex Mixtures

O autorze

Anthony B. Chen, Ph.D. has worked for over fifteen years at Genentech Inc. South San Francisco, CA developing analytical assays for recombinant protein pharmaceuticals. He introduced the use of novel analytical applications, including CE, for routine protein analyses in the Quality Control department.

Wassim Nashabeh, Ph.D. has worked with CE for over ten years, including pre- and postdoctoral studies and CE for commercial applications. He is Associate Director, Quality Control, Genentech Inc. where he has validated several CE methods used in the lot release of marketed protein therapeutics.

Timothy Wehr, Ph.D. developed CE instrumentation and application kits as manager of the CE chemistry R&D group at Bio-Rad laboratories, Richmond, CA and has developed CE methods for biopharmaceuticals at Bay Bioanalytical Laboratory, Richmond CA.

Blurb

The continuing development of capillary electrophoresis (CE) is evident by the increasing number of journal articles, text books and symposia devoted to CE. This monograph is part of a continuing series covering individual areas of CE.

The Symposium 'CE in Biotechnology: Practical Applications for Protein Analysis' was held in San Francisco, California, USA on August 18, 1999. The symposium highlighted practical applications, including methods which had obtained regulatory approval for the routine analysis of marketed recombinant protein pharmaceuticals. This meeting demonstrated that CE has found a niche in the routine analysis of proteins and peptides in an industrial setting. The editors of this monograph, along with the series editor (Kevin Altria) were of the opinion that the proceedings of that meeting could provide the basis for theoretical and practical issues related to the analysis of therapeutic proteins and peptides by CE. This publication therefore consists of some of the practical applications that were presented by scientists from leading biotechnology companies. Several comprehensive review chapters, including 'CE in the development of recombinant protein biopharmaceuticals', 'Selection of buffers in CZE: application to peptide and protein analysis' and 'Recent advances in cIEF' are included as supplemental information.

This publication should be read by those seeking to develop and/or validate methods to be used for routine analysis of proteins and peptides for drug development and quality control.