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Report of the Workshop on Monoclonal Antibodies

revolutionised clinical treatment and biomedical research. The original possibility of using this technique for replacing uses of laboratory animals often continues to be overlooked or ignored. In the decades following the original discovery, millions of animals died while available humane alternatives were under-utilised. Speakers in this workshop provided comprehensive information on state-of-theart current best practices for in vitro mAb production in commercial and research settings; a review of small-scale in vitro mAb production methods; consideration of the pros and cons of using in vitro methods, and a case study detailing one large pharmaceutical company’s switch to using only in vitro methods. Dr Coenraad Hendriksen (Netherlands Centre on Alternatives to Animal Use (NCA) and National Institute of Public Health and the Environment [RIVM], The Netherlands) set the stage for the workshop with a concise, comprehensive review of the processes involved in the creation and production of mAbs; the pros and cons of both in vivo and in vitro methods (with an emphasis on the animal welfare concerns associated with the former); and consideration of the legal status of in vivo ascites production in Europe and other countries. Dr Frances Weis-Garcia (Memorial SloanKettering Cancer Center, USA), discussed small scale in vitro mAb production, summarising in considerable detail what products are currently available and what issues need to be considered when selecting a mAb production system, both for meeting the needs of individual laboratories and core facilities. She noted that, with few exceptions, there is no longer a need to use animals for ascites production of mAbs. Based on the available literature and her personal experiences with running a major core production facility, Dr Weis-Garcia reviewed the basic attributes, advantages and limitations of examples of stationary (i.e. standard flasks, gas permeable bags, CELLine flasks and hollow fibre capillary systems) and suspension (i.e. roller bottles, gas permeable bags on rockers and the miniPERM) mAb in vitro production methods (Table 1). She also addressed actual performance characteristics of the most commonly utilised systems (Table 2). Since several of these approaches required adaption of the hybridoma cells to low fetal bovine serum (FBS) or serum-free conditions, this presentation included specific protocols to accomplish that goal. Dr Weis-Garcia’s contribution then focused on a detailed consideration of two specific in vitro sysReport of the Workshop on Monoclonal Antibodies