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Taken from the CONCLUSIONS AND RECOMMENDATIONS

"Alternatives in Monoclonal Antibody Production"

a workshop of
The Johns Hopkins Center for Alternatives to Animal Testing
and The Office for Protection from Research Risks
National Institutes of Health

September 24-25, 1997

Baltimore, MD

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The general consensus by the faculty and participants at the workshop was that there are acceptable in vitro methods for the production of most monoclonal antibodies and that these methods should replace the ascites method in most cases. Experiences in some European countries have shown that almost complete replacement of ascites production by in vitro techniques is possible, both for large scale and small scale production, without any effect on the quality of biomedical research or therapeutic interventions.

Conclusion and Recommendations

  1. Production of monoclonal antibodies (MABs) by the ascites method is painful and causes suffering for the animal.
  2. Once hybridomas have been created, there are replacement alternatives for producing most MABs.
  3. In most applications, in vitro alternatives produce adequate amounts of MABs. In some cases they may differ in cost- and time-efficiency.
  4. The concept of institutionally and NIH-supported core facilities for the in vitro production of MABs was strongly endorsed. Core laboratories would obviate the necessity for individual investigators to establish new technology in their laboratories, but core facility personnel could also provide instruction to investigators who may want to establish these techniques.
  5. In vitro methods for MAB production should be the accepted method. The use of the ascites method should be the exception and require rigorous and well-documented justification.
  6. Institutional Animal Care and Use Committees (IACUCs) should require investigators to use available alternatives unless they can provide adequate justification for an exception. Such justification should not be based solely on cost or convenience.
  7. If it is determined that specific hybridoma cells can only be grown via the ascites method to produce MABs, then the investigator should do everything possible to reduce the number of animals used and minimize the stress, pain, etc., that they experience.

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