Final Formulation

Final formulation can be considered as a part of purification in that it removes conditions that would impair the stability or utility of the antibody in its intended use. One goal of a purification strategy should be to limit the additional processing required to put the antibody into the final formulation. For example, ideally the antibody should be recovered from the final purification step in the same buffer needed for its final formulation. Often this can be done if this goal is kept in mind when the purification process is being developed.

Final formulation may be as simple as a straightforward sterilization by membrane filtration through a sterile filter with pores 0.2 im or less. Another relatively simple formulation step is adjusting the antibody concentration, either by dilution with buffer or by concentration on ultrafiltration. In other circumstances, the buffer composition may need to be changed to achieve optimal stability of the antibody. For this purpose, SEC or diafiltration is widely used. A more complex formulation step would be the addition of excipients to confer stability (95). Finally, the antibody solution may need to be lyophilized to confer stability, and the liquid formulation may be changed to be compatible with the lyophilization process. Such complex formulation strategies are beyond the scope of this article, so the reader is referred to reviews on this subject (95-97).

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