There are in vitro alternatives to monoclonal antibody production by ascites. In particular, high cell-density bioreactors are probably beyond the capability of most laboratories due to the high initial and ongoing material and labor costs and the specialized expertise required. In general, in vitro methods for monoclonal antibody production are considered standard and accepted practice. The use of the ascites method requires rigorous and well-documented justification. Justifications based solely on cost or convenience will not be considered adequate.
Most applications require only small quantities and low concentrations of antibodies.
Examples of common applications requiring only small quantities of antibody include immunoblots, immunoprecipitations, immunocytochemistry, flow cytometry, and small-scale affinity columns. Such applications are easily accommodated by use of unpurified tissue culture supernatants or by monoclonal antibodies purified from tissue culture supernatants. For purposes requiring up to approximately 10-50 mg of antibody, standard tissue culture methods involving growth of up to 50 liters of hybridoma cells should be considered the method of choice. These systems are relatively inexpensive and do not require specialized facilities or expertise. Investigators with applications that require up to 1 g of monoclonal antibody should consider the use of this in vitro alternative for production.