Chapter 6. Characterization and Bioanalytical Aspects of Recombinant Proteins as Pharmaceutical Drugs

  1. Dr. Oliver Kayser,
  2. Prof. Dr. Rainer H. Müller
  1. Dr. Jutta Haunschild,
  2. Dr. Titus Kretzschmar

Published Online: 28 JAN 2005

DOI: 10.1002/3527602410.ch6

Book Title

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Additional Information

How to Cite

Haunschild, J. and Kretzschmar, T. (2005) Characterization and Bioanalytical Aspects of Recombinant Proteins as Pharmaceutical Drugs, in Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications (eds O. Kayser and R. H. Müller), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, FRG. doi: 10.1002/3527602410.ch6

Editor Information

  1. Free University Berlin, Institute of Pharmacy, Pharmaceutical Technology, Biopharmacy & Biotechnology, Kelchstr. 31, 12169 Berlin, Germany

Author Information

  1. MorphoSys AG, Lena-Christ-Strasse 48, 82152 Martinsried, Germany

Publication History

  1. Published Online: 28 JAN 2005
  2. Published Print: 28 JAN 2004

ISBN Information

Print ISBN: 9783527305544

Online ISBN: 9783527602414

SEARCH

CHAPTER TOOLS

Get PDF (122K)

Keywords:

  • pharmaceutical biotechnology;
  • characterization;
  • bioanalytical aspects;
  • recombinant proteins;
  • pharmaceutical drugs;
  • validation of bioanalytical assays;
  • immunogenicity of recombinant proteins

Summary

  • Introduction

  • Characterization of Purified Recombinant Proteins

    • Purity and Impurities

    • Identity

    • Quantification of the Protein

    • Stability, Storage, and Sterility

    • Specificity and Cross-reactivity

    • Potency Determination

      • General Aspects and Assays

      • Potency Determination in Biological Matrices

  • Validation of Bioanalytical Assays

    • Method Establishment

    • Pre-study Validation

      • Selectivity

      • Assay Calibration

      • Accuracy and Precision

      • Linearity

      • Stability

    • In-study Validation

  • Immunogenicity of Recombinant Proteins

    • Examples

    • Factors Leading to Immune Responses

    • Methods to Determine Anti-protein Antibodies

    • Prediction of Immunogenicity of Therapeutic Proteins in Humans

  • References

Get PDF (122K)