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Monoclonal Antibody Production (1999)

Chapter: Appendix A: Workshop on Methods of Producing Monoclonal Antibodies

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Suggested Citation:"Appendix A: Workshop on Methods of Producing Monoclonal Antibodies." National Research Council. 1999. Monoclonal Antibody Production. Washington, DC: The National Academies Press. doi: 10.17226/9450.
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Appendix A
Workshop on Methods of Producing Monoclonal Antibodies

November 10, 1998

Agenda

9:00–9:30 Is the mouse ascites method painful?-Via Telephone Gebhart

9:30–3:00 Presentation by workshop participants:

9:30 - Mr. Tim DeSutter

9:45 - Dr. James Valdes

10:00 - Dr. John Reddington

10:15 - Break

10:30 - Dr. Simon Saxby

10:45 - Dr. Vahe Bedian

11:00 - Dr. Joseph Chandler

11:15 - Ms. Tracie Letterman

11:30 - Dr. Paul E. Thomas

11:45 - Questions and Answers

12:00 - Lunch for Committee and Workshop Participants

1:00 - Dr. Kathryn Stein

1:15 - Dr. Peter Maxim

1:30 - Dr. Dennis Dixon

1:45 - Dr. Arturo Casadevall

2:00 - Dr. John McArdle

2:15 - Dr. Louis Detolla

3:00 Adjourn

Suggested Citation:"Appendix A: Workshop on Methods of Producing Monoclonal Antibodies." National Research Council. 1999. Monoclonal Antibody Production. Washington, DC: The National Academies Press. doi: 10.17226/9450.
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Workshop Participants

    1.  

    Dr.Vahe Bedian, Principal Research Investigator, Pfizer Central Research

    2.  

    Dr. Arturo Casadevall, Department of Microbiology & Immunology, Albert Einstein College of Medicine

    3.  

    Dr. Joseph Chandler, President, Maine Biotechnology Services, Inc.

    4.  

    Mr. Tim DeSutter, Vice President, Integra Biosciences, Inc.

    5.  

    Dr. Louis Detolla, Chairman, Comparative Medicine Program, University of Maryland

    6.  

    Dr. Dennis Dixon, Chief, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, NIH/NIAID

    7.  

    Ms. Tracie Letterman, Esquire, International Center for Technology Assessment

    8.  

    Dr. Peter Maxim, FDA/CDRH

    9.  

    Dr. John McArdle, Director, Alternatives Research and Development Foundation

    10.  

    Dr. John Reddington, DiagXotics, Inc.

    11.  

    Dr. Simon Saxby, Director, Contract Operations, Unisyn Technologies

    12.  

    Dr. Kathryn Stein, Director, Division of Monoclonal Antibodies, FDA/CBER

    13.  

    Dr. Paul E. Thomas, Professor, Department of Chemical Biology, Rutgers the State University

    14.  

    Dr. James Valdes, Edgewood Research Development & Engineering Center

    Suggested Citation:"Appendix A: Workshop on Methods of Producing Monoclonal Antibodies." National Research Council. 1999. Monoclonal Antibody Production. Washington, DC: The National Academies Press. doi: 10.17226/9450.
    ×
    Page 55
    Suggested Citation:"Appendix A: Workshop on Methods of Producing Monoclonal Antibodies." National Research Council. 1999. Monoclonal Antibody Production. Washington, DC: The National Academies Press. doi: 10.17226/9450.
    ×
    Page 56
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    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.

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