As has been seen, antibodies can be remarkably diverse. One problem seen is when an antibody does not behave in a fashion similar to others of the same isotype. The solution of this type of problem is just good old-fashioned process optimization.
A much more serious problem is the purification of an antibody with limited solubility. A wide variety of additives can potentially be used for solubilization of antibodies, including urea, guanidine HCl, detergents, and sugars. Needless to say, there is the potential for these agents to interfere with purification steps as well. Thus, solution of this problem tends to require rather extensive development (48).
A similar problem is lack of stability. This may be intrinsic to the antibody, that is, it occurs even under physiological conditions, or it may be caused by a harsh purification condition, such as a low pH protein A elution or a virus-killing step. In the second case, generally alternate conditions are possible. Examples ofalternates for both the examples are given earlier in this article. The solution of an intrinsic stability problem is similar to that of a solubility problem. These problems can be quite complicated and are beyond the scope of this article, but good references are available (98,99).
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