ABSTRACT
Monoclonal antibodies produced from hybridoma cells are a significant part of the biotechnology boom that began in the mid 1970s. Monoclonal antibodies have two very important advantages over conventional polyclonal antibodies: high specificity and the ability to be produced in an unlimited supply and with a constant specificity and affinity. Alternatively, and in most cases, preferably, large quantities of antibody can be produced by tissue culture methods. There are many variations on the methods of tissue culture propagation. Monoclonal antibodies have variability in classes, subclasses, clones, variants, and batches. The amount and type of contaminants vary in different production systems. The nature of the production of monoclonal antibodies, whether from ascites fluid or from tissue culture methodologies, makes the product susceptible to viral contamination. Different strategies can be applied to the scaleup for industrial processes. W. B. Lebherz has reviewed many of the considerations for large-scale production of monoclonal antibodies.
