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From Clone to Clinic

  • Book
  • © 1990

Overview

Editors:
  1. D. J. A. Crommelin

    1. Faculty of Pharmacy, Department of Pharmaceutics, University of Utrecht, Utrecht, The Netherlands

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    You can also search for this editor in PubMed   Google Scholar

  2. H. Schellekens

    1. TNO Primate Center, Rijswijk, The Netherlands

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

Part of the book series: Developments in Biotherapy (DIBI, volume 1)

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Table of contents (46 chapters)

  1. Front Matter

    Pages i-xvi
    Download chapter PDF

  2. Registration, Toxicity and Quality Control

    1. Toxicity Testing of rDNA Products

      • A. D. Dayan
      Pages 1-11

    2. Experiences with the EC “High Tech” Procedure

      • H. J. M. van de Donk, I. Hegger
      Pages 13-19

    3. The Regulation of Pharmaceuticals: Philosophy and Principles

      • John C. Petricciani
      Pages 21-28

    4. Quality Control of Vaccines

      • J. H. Peetermans
      Pages 29-35

    5. Regulatory Affairs and Biotechnology in Europe: The CPMP “High Tech” and Multi-State Procedures

      • Ben Tryzelaar
      Pages 37-43

    6. Formulating Biotechnology Products

      • T. Mundorf
      Pages 45-55

    7. Development of Analytical Methods for Monitoring the Stability of Antibody Formation by Hybridoma Cells in Continuous Culture Systems

      • J. M. Coco Martin, P. Koolwijk, D. E. Martens, J. W. Oberink, C. A. M. van der Velden-de Groot, E. C. Beuvery
      Pages 57-65

  3. Monoclonal Antibodies

    1. Toward Human Monoclonal Antibodies

      • Dennis R. Burton, Mats A. Persson, William D. Huse, Edward S. Golub
      Pages 67-72

    2. Biodistribution, Binding and Internalisation of Monoclonal Antibodies to Human Ovarian Carcinoma Cells

      • L. G. Poels, O. C. Boerman, L. Massuger, R. Claessens, U. K. Nässander, Q. van Hoessel et al.
      Pages 73-81

    3. Pharmacokinetics and Tissue Distribution of Indium-111-Labeled OV-TL 3 F(ab’)2 in Ovarian Cancer Patients

      • Leon F. A. G. Massuger, Roland A. M. J. Claessens, Lambert G. Poels, René H. M. Verheijen, Charles P. T. Schijf, Frans H. M. Corstens et al.
      Pages 83-88

    4. Characterization of Human Monoclonal Antibodies Specific for the Rabies Virus

      • Léna Edelman, Monique Lafon
      Pages 89-93

    5. Biochemical and Immunological Evalution of an Anti-Fibrin Monoclonal Antibody Complex Containing T2G1s Fab’ Intended for Imaging Venous Thrombi

      • P.-H. Lai, J. Brown, L. A. Epps, K. George, A. Sautter, C. Coonley et al.
      Pages 95-103

    6. Monoclonal Antibodies in Radioimmunoscintigraphy Some hurdles between clone and clinic

      • D. Blok, R. I. J. Feitsma, E. K. J. Pauwels
      Pages 105-110

    7. Clinical Relevance of the Tumor Marker CA 15.3 in the Management of Cancer Patients

      • G. G. Bon, P. Kenemans, C. A. Yedema, G. J. van Kamp, H. W. Nijman, J. Hilgers
      Pages 111-122

    8. Practical Applications of Monoclonal Antibodies Against Polymorphic Epithelial Mucin in the Differential Diagnosis of Human Tumors

      • J. Hilgers, P. Kenemans
      Pages 123-133

    9. Selection of Monoclonal Anti-Digoxin Antibodies Suitable for Monitoring of Cardiac Glycosides

      • Sonja N. Tyutyulkova, Stanimir D. Kyurkchiev, Ivan R. Kehayov
      Pages 135-141

    10. Diagnostic Use of Anti-Modified Nucleoside Monoclonal Antibodies

      • Michinao Mizugaki, Kunihiko Itoh, Nakao Ishida
      Pages 143-148

    11. Monoclonal Antibodies Radiolabeled with Different Radioisotopes for Biodistribution and Radioimmunodetection of Tumor Xenografts in the Nude Rat

      • M. W. A. de Jonge, J. G. W. Kosterink, Yan bin Yu, J. W. M. Bulte, R. A. M. Kengen, T. H. The et al.
      Pages 149-157

    12. Bispecific Monoclonal Antibody (Biab)-Retargeted Cellular Therapy for Local Treatment of Cancer Patients

      • L. de Leij, M. W. A. de Jonge, J. ter Haar, H. Spakman, E. de Vries, P. Willemse et al.
      Pages 159-165
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Keywords

About this book

This book contains a selection of the papers presented at the meeting "Between Clone and Clinic" which was organised in March 1990 in Amsterdam by the dutch Organisation for Applied Research, TNO, and the University of Utrecht. The scope of this meeting was the development of biotechnological pharmaceuticals mainly made by recombinant DNA technology or monoclonal antibody techniques. All aspects concerning the development of the products after host cells producing them are obtained where discussed. The meeting was attended by twohundred specialists from all over the globe, including phar­ macologists, toxicologists, registration experts, Quality Assurence managers, production en­ gineers and physicians. Biotechnological pharmaceuticals are in general large and complex protein molecules. Bringing these products to the market poses other problems than encountered with the classical chemical drugs. The source of biotechnological pharmaceuticals are living cells. The function of cells are depend­ ent on many factors and the stability of production may be a problem. Good Laboratory and Manufactory Practices with Quality Control (GLP and GMP) are of paramount importance and are discussed in a number of papers. The products of the new biotechnology are often highly specific and only active in the human species. Also the side effects can only be studied in the clinical setting. Even when the product is active in animals there is the problem of antigenicity. During treatment the animals will produce antibodies which neutralise the activity. So safety testing may prove difficult.

Editors and Affiliations

  • Faculty of Pharmacy, Department of Pharmaceutics, University of Utrecht, Utrecht, The Netherlands

    D. J. A. Crommelin

  • TNO Primate Center, Rijswijk, The Netherlands

    H. Schellekens

Bibliographic Information

  • Book Title: From Clone to Clinic

  • Editors: D. J. A. Crommelin, H. Schellekens

  • Series Title: Developments in Biotherapy

  • DOI: https://doi.org/10.1007/978-94-011-3780-5

  • Publisher: Springer Dordrecht

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer Science+Business Media Dordrecht 1990

  • Hardcover ISBN: 978-0-7923-0945-1Published: 31 October 1990

  • Softcover ISBN: 978-94-010-5683-0Published: 09 November 2012

  • eBook ISBN: 978-94-011-3780-5Published: 06 December 2012

  • Series ISSN: 0925-7640

  • Edition Number: 1

  • Number of Pages: XVI, 379

  • Topics: Pharmacology/Toxicology, Immunology, Oncology

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