Popis: |
Over the years chromatography has proven itself as the work horse for purification of biologics. General rules and considerations for chromatographic separations are well defined and understood. They are briefly discussed in this chapter. The discussion should provide a good basis for developing, evaluating, scaling-up and optimizing chromatography steps. Since many of the aspects discussed in the chapter are independent of the type of chromatography technique used in bioprocessing, they are referred to as general principles. More detailed reviews of the most commonly used chromatography purification techniques for manufacturing of biologics are provided in separate chapters in this book. The basic concepts discussed in the chapter include: classification of chromatography stationary phases, mass transfer phenomena occurring during protein chromatography, typical modes of operations and their common performance descriptors. In addition, important aspects from the modes of operations, scale-up, and process economy perspective are described. The chapter also covers basics of process development and optimization of chromatography separations. The list of references cited throughput the chapter should provide a good starting point for exploring a vast field of preparative protein chromatography. |