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Alternatives to Monoclonal Antibody Production (Proceedings)

Conclusions and Recommendations

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 monoclonalantibodies (MABs) by the ascites method is painful and causessuffering for the animal.
  2. Once hybridomas have beencreated, there are replacement alternatives for producingmost MABs.
  3. In most applications, invitro alternatives produce adequate amounts of MABs.In some cases they may differ in cost- and time-efficiency.
  4. The concept of institutionallyand NIH-supported core facilities for the in vitroproduction of MABs was strongly endorsed. Core laboratorieswould obviate the necessity for individual investigatorsto establish new technology in their laboratories, but corefacility personnel could also provide instruction to investigatorswho may want to establish these techniques.
  5. In vitro methodsfor MAB production should be the accepted method. The useof the ascites method should be the exception and requirerigorous and well-documented justification.
  6. Institutional Animal Careand Use Committees (IACUCs) should require investigatorsto use available alternatives unless they can provide adequatejustification for an exception. Such justification shouldnot be based solely on cost or convenience.
  7. If it is determined thatspecific hybridoma cells can only be grown via the ascitesmethod to produce MABs, then the investigator should doeverything possible to reduce the number of animals usedand minimize the stress, pain, etc., that they experience.

Investigators and IACUCs should be made aware of the concept of the Three Rs and encouraged to consult existing references and resources, such as the Altweb site, AWIC, OPRR Web site, etc.

New ALTEX: 3/2017
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