Introduction Scope

This review focuses on the fullest extent of purification: that needed for an injectable or parenteral product for human use. This application requires the use of multistep procedures, with steps of high resolution (1,2). Many uses of antibodies do not require such stringent purity. Our objective is to present methods that when combined are capable of achieving parts-per-million levels of contaminants, with the understanding that such criteria are not needed for many uses of antibodies. In such cases, single steps of many of the methods presented will prove to be adequate.

Our focus is also primarily on monoclonal antibodies, which now dominate the antibody field, but we include a special section on polyclonal antibodies. Similarly, we describe purification processes for the IgG and IgM classes only, because these account for almost all uses of antibodies. Occasional reference is made to purification of the IgA subclass, whose use is rare.

Our discussion is limited to methods of purification. The choice of equipment needed to carry out these methods is a very broad topic. It depends on whether process development or production is being performed. It also depends on the scale, on whether the method is good manufacturing process (GMP) or not, and on the nature of the antibody being purified. Thus, details of this selection process are beyond the scope of this article.

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