A hollow fibre dialysis system for the in vitro production of monoclonal antibodies replacing in vivo production in mice.

Haemodialysis units have been used as bioreactors for the in vitro production of monoclonal antibodies. Mouse hybridomas were grown in the extra-capillary compartment of dialysis modules with a constant supply of protein-free medium through the hollow fibres. It was found that addition of serum to the media had no stimulatory effect on the production of monoclonal antibodies. For the determination of monoclonal antibodies a sol particle immunoassay (SPIA) has been used. Monoclonal antibodies were harvested from the extra-capillary compartment at two-week intervals over periods of several weeks at concentrations comparable to the harvests of ascitic fluids from mice. The production capacity of one haemodialysis unit is equivalent to that of at least 50 mice. This in vitro system enables a yearly production of 50 grams per unit of monoclonal antibodies of high purity and devoid of contaminants from mouse origin or serum. It has been shown that this system can be successfully used to produce a constant supply of monoclonal antibodies for a variety of applications, e.g. reagents for diagnostic tests and materials for immuno-chromatographic purification. As a consequence this in vitro production of monoclonal antibodies has replaced the many thousands of mice required for in vivo production.