Characterization of Biotechnology Pharmaceutical Products: Symposium, Washington, D.C., December 1995. - Developments in Biologicals 96 (Paperback)
  • Characterization of Biotechnology Pharmaceutical Products: Symposium, Washington, D.C., December 1995. - Developments in Biologicals 96 (Paperback)
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Characterization of Biotechnology Pharmaceutical Products: Symposium, Washington, D.C., December 1995. - Developments in Biologicals 96 (Paperback)

(editor)
£90.75
Paperback 212 Pages / Published: 18/12/1998
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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.

Publisher: S Karger AG
ISBN: 9783805568050
Number of pages: 212
Weight: 450 g
Dimensions: 230 x 170 x 13 mm

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