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Well-packed columns, in which the beds are homogeneous and continuous from top to bottom, exhibit the best chromatographic separations. When transferring a downstream process, it's critical to maintain as many control parameters as possible including preparation procedures. Column packing for manufacturing has historically required drastically divergent procedures compared with laboratory scale, which can lead to wide variability in chromatographic beds. Furthermore, the ever-expanding catalog of chromatography media may require highly specialized techniques for packing.
Procedures for packing chromatography columns should be scalable and reproducible as well as flexible to allow for modifications to support various types of chromatography media. Bio-Rad InPlace™ columns are designed to suit packing needs for pilot and manufacturing scale, and the packing protocols are directly scalable because the media bed is consolidated uniformly using axial compression.
Presenter: Kimberly C. Brisack, Manager, Process Chromatography Applications Laboratory, Bio-Rad Laboratories
Kim attended the University of California at Berkeley for undergraduate and graduate school. She spent eleven years in biotechnology, where she held several positions in downstream manufacturing and validation, purification process development, and manufacturing support. She has been involved in multiple aspects of pharma development and manufacturing including process optimization, process and cleaning validations, and technology transfer. Kim joined Bio-Rad in 2007, and her work has centered on process-scale column packing methodologies and scale-up behavior of chromatography media.
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