Characterization of biotechnology pharmaceutical products : Washington D.C., USA December 11-13, 1995
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Bibliographic Information
Characterization of biotechnology pharmaceutical products : Washington D.C., USA December 11-13, 1995
（Developments in biological standardization, v. 96）
Karger, c1998
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Proceedings of a Symposium organized and sponsored by The Food and Drug Administration/Center for Biologics Evaluation and Research (FDA/CBER)
Description and Table of Contents
Description
This publication addresses the parameters necessary for characterizing the safety, identity, purity, consistency and potency of biotechnology-derived products. The abilities and limitations of current analytical methodologies for defining such products and for assessing their comparability during development are examined. The data reviewed in this volume serve as a foundation for defining the properties of well-characterized products, including proteins and other molecular entities. Discussions span the evaluation of antigenic potential, potency, impurities, DNA/plasmid products, multiantigen peptides, polysaccharides, derivatized proteins, monoclonal antibodies and proteins from natural sources. Finally, recommendations for a consistent approach to the regulation of well-characterized biotechnology products are provided.
Table of Contents
- Well-characterized biotechnology products - evolving to meet the needs of the 21st century, K.C. Zoon
- Part 1 Characterization of protein-based pharmaceutical products (1): application of new analytical technology to the production of a "well-characterized biological", A. Apffel et al
- characterization of protein primary structure, D.W. Speicher
- estimation of secondary/tertiary structure, P. McPhie
- structural characterization of proteins by NMR, S. Grzesiek
- biological importance of glycosylation, R.A. Dwek
- evaluation of glycosylation, V.N. Reinhold. Part 2 Characterization of protein-based pharmaceutical products (2): purity of biological products - related and unrelated impurities, a.C. Herman
- evaluation of potency for well characterized biotechnology proteins, D.S. Finbloom. Part 3 Concurrent breakout sessions I: evaluation and concerns for antigenic potential
- determination of potency
- evaluation of impurities
- evaluation of DNA/plasmid products
- . Part 4 Evaluation of case studies of protein-based pharmaceuticals: establishment of criteria for determining comparability of "well-characterized" proteins, J.A. Cavagnaro
- evaluation of product comparability, S.E. Builder
- the development of recombinant human insulin, B.H. Frank
- betaseron, L. Lin
- the human growth hormone saga, E. Canova-Davis
- rtPA is a well-characterized protein, J.V. O'Connor
- erythropoietin, M.F. Rohde
- hepatitis B vaccine, C. Capiau
- cerezyme - a case study, T. Edmunds
- recombinate - antihaemophilic factor, H.A. Scoble. Part 5 Concurrent breakout sessions: evaluation of multi-antigen peptides
- evaluation of polysaccharides
- evaluation of derivatized proteins
- evaluation of monoclonal antibodies
- evaluation of highly purified protein pharmaceuticals from natural sources
- Part 6 Pane l discussion: process validation, M.G. Beatrice
- relationships among product characterization, process validation and preclinical/clinical studies for well-characterized products, A.S. Lubinieccki
- summary of panel topic discussions, R. Devine.
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