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Monoclonal Antibody Production The Report and Recommendations of ECVAM Workshop 23

Uwe Marx, M. Jim Embleton, René Fischer, Franz P. Gruber, Ulrika Hansson, Joachim Heuer, Wim A. de Leeuw, Ton Logtenberg, Wolfram Merz, Daniel Portetelle, John-Louis Romette and Donald W. Straughan

This is the report of the twenty-third of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM).  The workshop on Monoclonal Antibody Production was held in Angera, Italy, on 19–22 November 1996, under the chairmanship of Uwe Marx (University of Leipzig, Germany). The aim of the workshop was to evaluate the present status of in vitro methods for monoclonal antibody (mAb) production, and to compare the advantages and disadvantages of the in vitro methods with those of the traditional in vivo (malignant ascites) method. The workshop participants assessed various in vitro culture systems for the propagation of hybridoma cells in terms of: a) the antibody production capacity; b) the concentration, yield and quality of the mAbs produced; and c) the capital and running costs of operation. The participants felt  that there are already several scientifically satisfactory in vitro methods which are both reasonably and practicably available. As these are of moderate cost, and can be shown to be either better than, or equal to, the ascites production method in terms of antibody quality, they concluded that the in vivo production of mAbs is no longer necessary, except in rare cases where it is already approved for clinical applications. In this respect a guideline on mAb production was discussed at the workshop, and a proposed guideline is included as an Appendix to this report. Differences between national policies and legal controls in several European countries on ascites production were identified, and recommendations have been made to try to increase the routine use of in vitro methods by mAb producers and users. The specific conclusions and recommendations made during the workshop are summarised in the final section of this report.