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From Clone to Clinic

  • D. J. A. Crommelin
  • H. Schellekens

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

Table of contents

  1. Front Matter
    Pages i-xvi
  2. Registration, Toxicity and Quality Control

    1. A. D. Dayan
      Pages 1-11
    2. H. J. M. van de Donk, I. Hegger
      Pages 13-19
    3. J. H. Peetermans
      Pages 29-35
    4. T. Mundorf
      Pages 45-55
    5. 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. Dennis R. Burton, Mats A. Persson, William D. Huse, Edward S. Golub
      Pages 67-72
    2. L. G. Poels, O. C. Boerman, L. Massuger, R. Claessens, U. K. Nässander, Q. van Hoessel et al.
      Pages 73-81
    3. 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. D. Blok, R. I. J. Feitsma, E. K. J. Pauwels
      Pages 105-110
    5. G. G. Bon, P. Kenemans, C. A. Yedema, G. J. van Kamp, H. W. Nijman, J. Hilgers
      Pages 111-122
    6. Sonja N. Tyutyulkova, Stanimir D. Kyurkchiev, Ivan R. Kehayov
      Pages 135-141
    7. Michinao Mizugaki, Kunihiko Itoh, Nakao Ishida
      Pages 143-148
    8. 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
    9. L. de Leij, M. W. A. de Jonge, J. ter Haar, H. Spakman, E. de Vries, P. Willemse et al.
      Pages 159-165
    10. R. Bos, M. Otter, W. Nieuwenhuizen
      Pages 167-174
    11. R. P. McCabe, M. V. Haspel, J. A. Carrasquillo, R. G. Steis, N. Pomato, R. Subramanian et al.
      Pages 175-188
    12. R. C. Straube, C. R. Smith, I. E. Allen, C. P. Dating, C. Kilgarriff, J. B. Cornett et al.
      Pages 189-194
    13. G. Hale, M. J. S. Dyer, M. R. Clark, H. Waldmann
      Pages 195-199
    14. D. E. Martens, Martin J. Coco, Cam van der Velden-De Groot, E. C. Beuvery, C. D. de Gooijer, J. Tramper
      Pages 209-217
  4. Marketed products

    1. L. Nelles, D. Collen
      Pages 219-226
    2. H. Toba, I. Tsuyuguchi, H. Kimura, H. Fujiwara, S. Hanamoto, H. Kawasumi et al.
      Pages 227-232
  5. New Products

    1. P. van Wezenbeek, J. Draaijer, F. van Meel, W. Olijve
      Pages 245-251
    2. W. de Boer, B. Mannaerts
      Pages 253-259
    3. R. W. van Leen, P. J. Lemson, J. G. Bakhuis
      Pages 261-268
    4. B. Noordam, R. F. W. C. van Beckhoven, R. van Lambalgen, N. L. M. Persoon
      Pages 269-274
    5. L. Borecký, P. Kontsek, V. Lackovič, J. Mistríková, M. Novák
      Pages 275-281
    6. L. Ozmen, M. Fountoulakis, D. Stüber, G. Garotta
      Pages 283-289
  6. Drug Delivery

    1. J. P. Kamerling, K. Hård, J. F. G. Vliegenthart
      Pages 295-304
    2. A.-P. Wei, J. N. Herron, J. D. Andrade
      Pages 305-313
    3. G. F. A. Kersten, E. C. Beuvery, D. J. A. Crommelin
      Pages 315-322
    4. J. Verhoef, W. A. J. J. Hermens, M. J. M. Deurloo, S. G. Romeijn, N. G. M. Schipper, F. W. H. M. Merkus
      Pages 323-328
    5. C.-M. Lehr, J. A. Bouwstra, J. J. Tukker, J. Verhoef, A. G. de Boer, H. E. Junginger
      Pages 329-334
    6. Martin Mackay
      Pages 335-342
    7. Andrew L. Shorter, Mary Beth Seaman, Donna Dunleavy, Patricia Smialkowski, Daniel Schrader
      Pages 343-356
    8. U. K. Nässander, G. Storm, P. A. Steerenberg, W. H. De Jong, G. de Groot, L. G. Poels et al.
      Pages 357-365
    9. Q. Shen, V. W. van Beusechem, M. P. W. Einerhand, D. Valerio
      Pages 367-372
    10. R. C. Hoeben, M. P. W. Einerhand, S. J. Cramer, E. Briët, H. van Ormondt, D. Valerio et al.
      Pages 373-378
  7. Back Matter
    Pages 379-379

About this book

Introduction

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.

Keywords

research

Editors and affiliations

  • D. J. A. Crommelin
    • 1
  • H. Schellekens
    • 2
  1. 1.Faculty of Pharmacy, Department of PharmaceuticsUniversity of UtrechtUtrechtThe Netherlands
  2. 2.TNO Primate CenterRijswijkThe Netherlands

Bibliographic information

  • DOI https://doi.org/10.1007/978-94-011-3780-5
  • Copyright Information Kluwer Academic Publishers 1990
  • Publisher Name Springer, Dordrecht
  • eBook Packages Springer Book Archive
  • Print ISBN 978-94-010-5683-0
  • Online ISBN 978-94-011-3780-5
  • Series Print ISSN 0925-7640
  • Buy this book on publisher's site