Membrane filtration.

Abstract

The filtration of protein solutions, especially in the manufacture of biologically derived proteins, is a large and increasingly important step in the production of protein pharmaceuticals. The focus of this chapter is on the use of membrane filters for purification and sterilization of protein pharmaceuticals. However, we also review other important uses of membranes and nonmembrane filters in the production of protein pharmaceuticals. The reader is directed to several useful reference books that describe in more detail both the theory and the practice of filtration in the biopharmaceutical industry (Cheryan, 1986; Ho and Sirkar, 1992; Johnston, 1992a; Meltzer, 1987; Meltzer and Jornitz, 1998). Additional discussion of interactions between filters and protein formulations can be found in Chapters 2 and 3. The appendix to this chapter contains definitions of terms for those readers unfamiliar with terminology of membrane filtration.KeywordsCleaning AgentFinal FilterProtein PharmaceuticalBiopharmaceutical IndustryRejection CoefficientThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.