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Monoclonal Antibody Production (1999) / Chapter Skim
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Executive Summary
Pages 1-4

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From page 1...
... Further processing of the mouse ascitic fluid and of the tissue culture supernatant might be required to obtain mAb with the required purity and concentration. The mouse method is generally familiar, well understood, and widely available in many laboratories; but the mice require careful watching to minimize the pain or distress that some cell lines induce by excessive accumulation of fluid (ascites)
From page 2...
... There are several reasons why the mouse method of producing mAb cannot be abandoned: some cell lines do not adapt well to tissue-culture conditions; in applications where several different mouse mAb at high concentrations are required for injection into mice, the in vitro method can be inefficient; rat cell lines usually do not efficiently generate mAb in rats and adapt poorly to tissue-culture conditions but do produce mAb in immunocompromised mice; downstream puri
From page 3...
... Recommendation 3: When the mouse ascites method for producing mAb is used, every reasonable effort should be made to minimize pain or distress, including frequent observation, limiting the numbers of taps, and prompt euthanasia if signs of distress appear. Two of 13 mAb approved by the Food and Drug Administration for therapeutic use cannot be produced by in vitro means, or converting to an in vitro system for their production would require (because of federal regulations)
From page 4...
... 5. When more than 50 mg of functional mAb is needed, and previous poor performance of the cell line indicates that hollow-fiber reactors, small-volume membrane-based fermenters, or other techniques cannot meet this need during optimal growth and production.


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