The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of
Health (NIH) in early 1997 to prohibit the use of an animal in the production of mAb
(monoclonal antibodies). NIH responded late in 1997, asserting that continued use of
the mouse method for producing mAb was scientifically required. In a second
petition, in early 1998, AAVS did not accept the NIH response. NIH asked the
National Research Council to form a committee to study this issue. The Committee on
Methods of Producing Monoclonal Antibodies was composed of 11 experts with extensive
experience in biomedical research, laboratory animal medicine, pain research, animal
welfare, and patient advocacy. The committee was asked to determine whether there is
a scientific necessity for producing mAb by the mouse method and, if so, to
recommend ways to minimize any pain or distress that might be associated with the
method. The committee was also to determine whether there are regulatory
requirements for the mouse method and to summarize the current stage of development
of tissue-culture methods.
This study was supported by Contract No.
N01-OD-4-2139 between the National Academy of Sciences and the National Institutes
Any opinions, findings, conclusions, or recommendations expressed in this publication
are those of the author(s) and do not necessarily reflect the views of the
organizations or agencies that provided support for the project.
NOTICE: The project that is the subject of this report was approved by the Governing
Board of the National Research Council, whose members are drawn from the councils of
the National Academy of Sciences, the National Academy of Engineering, and the
Institute of Medicine. The members of the committee responsible for the report were
chosen for their special competences and with regard for appropriate balance.
© 1999, National Academy of