22. Regulation of Antibodies and Recombinant Proteins

  1. Prof. Dr. H.-J. Rehm3,
  2. Dr. G. Reed4
  1. Julie Foulkes1,
  2. Gillian Traynor2

Published Online: 20 MAR 2008

DOI: 10.1002/9783527620869.ch22

Biotechnology: A: Recombinant Proteins, Monoclonal Antibodies, and Therapeutic Genes, Volume 5a, Second Edition

Biotechnology: A: Recombinant Proteins, Monoclonal Antibodies, and Therapeutic Genes, Volume 5a, Second Edition

How to Cite

Foulkes, J. and Traynor, G. (2008) Regulation of Antibodies and Recombinant Proteins, in Biotechnology: A: Recombinant Proteins, Monoclonal Antibodies, and Therapeutic Genes, Volume 5a, Second Edition (eds H.-J. Rehm and G. Reed), Wiley-VCH Verlag GmbH, Weinheim, Germany. doi: 10.1002/9783527620869.ch22

Editor Information

  1. 3

    Institut für Mikrobiologie, Universität Münster, Corrensstraße 3, D-48149 Münster, FRG

  2. 4

    1029 N. Jackson St., #501-A, Milwaukee, WI 53202-3226, USA

Author Information

  1. 1

    Burnham, UK

  2. 2

    Cambridge, UK

Publication History

  1. Published Online: 20 MAR 2008
  2. Published Print: 26 NOV 1998

ISBN Information

Print ISBN: 9783527283156

Online ISBN: 9783527620869

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Keywords:

  • immunizing;
  • extraction;
  • jurisdiction;
  • assessment;
  • antibody

Summary

The prelims comprise:

  • Introduction

  • Registration of Biotechnology Products in the USA

  • Registration of Biotechnology Products in Europe

  • Conclusions and the Way Forward for the Regulation of Biotechnology-Derived Products