Institutional Animal Care & Use Committee, Yale University

Yale University
Institutional Animal Care
& Use Committee
New Haven CT
USA 06510

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Policy for the Production of Monoclonal Antibodies Using the Mouse Ascites Method

Background:

As a result of petitions to ban the use of the mouse ascites method in the preparation of monoclonal antibodies, the National Research Council of the National Academy of Sciences released a report in April, 1999. The overall finding of the 1999 report was that in vitro methods of monoclonal antibody production should be used whenever possible.

Federal Guidelines state that prior to approving protocols that propose the production of monoclonal antibodies using the mouse ascites method, the following written documentation must be provided to the IACUC for consideration:

1.	the proposed use of animals is scientifically justified
2.	methods used that will avoid or minimize discomfort, distress, and pain (including in-vitro methods),
3.	why in-vitro method(s) has been found to be unsuitable.

It is the responsibility of the IACUC to critically evaluate the above criteria and appropriately document that they have been fulfilled. According to the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH) this is considered central to Yale's compliance with its Animal Welfare Assurance and the PHS Policy.

Policy:

While there are legitimate circumstances for use of the mouse ascites method*, there is evidence that this method causes discomfort, distress, and/or pain. Practical in-vitro methods exist which can replace the ascites method in many experimental applications without compromising the aims of the study. Thus, the use of the mouse ascites method should be the exception.

Guidelines:

Based on Federal Guidelines, the following steps should be followed when preparing a protocol:

1.	In vitro alternatives for producing monoclonal antibodies should be the preferred method with the mouse ascites method being the exception.
2.	Document the reason for believing the in vitro system(s) tried was most appropriate and why it proved to be unacceptable
3.	Provide assurance that the antibody to be used is not commercially available
4.	Scientific justification should not be based on cost or convenience.

*Acceptable exceptions to using in vitro alternatives may be instances where the hybridoma cells grown in culture either failed to produce Mabs or fail to produce Mabs with the proper reactivity needed to answer important research questions.

REVIEWED AND APPROVED BY THE IACUC: 10/18/00