Monoclonal antibody production / Committee on Methods of Producing Monoclonal Antibodies, Institute for Laboratory Animal Research, National Research Council.

Format:

Book

Author/Creator:

Institute of Laboratory Animal Resources (U.S.). Committee on Methods of Producing Monoclonal Antibodies.

Contributor:

National Research Council (U.S.)

Language:

English

Subjects (All):

Monoclonal antibodies--Synthesis--Methodology.

Monoclonal antibodies.

Hybridomas.

Mice as laboratory animals.

Physical Description:

1 online resource (xiv, 59 pages)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1999.

Language Note:

English

Summary:

The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.

Contents:

Front Matter

Preface

Contents

Executive Summary

Introduction

1 Generation of Hybridomas: Permanent Cell Lines Secreting Monoclonal Antibodies

2 In Vitro Production of Monoclonal Antibody

3 Scientific Needs for Mouse Ascites Production of mAb

4 Summary of Advantages and Disadvantages of In Vitro and In Vivo Methods

5 Large-Scale Production of Monoclonal Antibodies

6 Animal-Welfare Issues Related to the Ascites Method for Producing Monoclonal Antibodies

7 Conclusions and Recommendations

References

APPENDIX A Workshop on Methods of Producing Monoclonal Antibodies

APPENDIX B Biographical Sketches of Authoring Committee.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references (p. 48-53).

ISBN:

9780309173056

0309173051

9780309519045

0309519047

9780585082424

0585082421

OCLC:

559576861