[Mass Production of Monoclonal Antibodies: Technical, Scientific and Ethical Considerations]
The mass production of monoclonal antibodies (MABs) becomes more important in the near future, in contrast to microorganisms, the antibody-producing hybridomas are very sensitive to the culture conditions in mass cell culture and therefore difficult to cultivate in bulk quantities. The most common in vitro and in vivo systems for the production of monoclonal antibodies in bulk preparations are discussed. For the mass production of monoclonal antibodies, several in vitro systems are in use or under development today: 1. Spinner flasks represent the most simple culture system for producing antibodies. Various mixing devices were developed and different culture media were used for an efficient growth of the cells. 2. Several fermenters exist for the growth of hybridoma cells and production of MABs with all kind of stirrers, mixing devices and electronic control equipment. It is proposed that the "dialysis fermenter" will be the favorite equipment for future mass production of MABs. 3. The capillary bioreactor is efficient for the production of MABs in small quantities. High cell densities and good quality of the harvested MABs can be achieved. 4. The most common production system is still the in vivo production of MABs in the ascites fluid of mice. Technical and ethical aspects of this in vivo production are discussed in the light of the new German law for the protection of animals in biomedical experiments.
Lindl
Toni
T
Institut für angewandte Zellkultur und Institut zur Erforschung von Alternativmethoden zum Tierversuch (IFA), D-München.