Ascites-Free In-Vitro Technology for Monoclonal Antibody Production

New NIH Guidelines Encourage Use of Ascites-Free In-Vitro Technology for Monoclonal Antibody Production

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The official NIH position is that the government will continue to promote alternatives whenever possible, and investigators will still be required to justify the use of in vivo antibody production on a case-by-case basis, as stipulated by the Public Health Service Policy There is evidence that the mouse ascites method of monoclonal antibody production causes discomfort, distress, or pain. Practical in vitro methods exist which can replace the ascites method in many experimental applications without compromising the aims of the study. (OPRR Report, number 98-01, Animal Welfare) IACUCs are expected to critically evaluate the proposed use of the mouse ascites method.Prior to approval of proposals which include the mouse ascites method, IACUCs must determine that (i) the proposed use is scientifically justified, (ii) methods that avoid or minimize discomfort, distress, and pain (including in vitro methods) have been considered, and (iii) the latter have been found unsuitable. Fulfillment of this three-part IACUC responsibility, with appropriate documentation, is considered central to an institution’s compliance with its Animal Welfare Assurance and the PHS Policy. (OPRR Report, number 98-01, Animal Welfare).

The federal mandate to avoid or minimize discomfort, pain, and distress in experimental animals, consistent with sound scientific practices, is, for all practical purposes, synonymous with a requirement to consider alternative methods that reduce, refine, or replace the use of animals. (OPRR Report, number 98-01, Animal Welfare. Because these longstanding requirements are central to the federal oversight of all animal-related activities in research, testing, and training, this guidance may also be applied more generally to other PHS-supported and non PHS-supported activities involving animals (OPRR Report, number 98-01, Animal Welfare).

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