Despite the recent surge in acceptance of single-use (SU) and disposable manufacturing systems, some challenges still exist in implementing a fully disposable process for antibody purification. The primary challenge is the near universal acceptance of a Protein A based purification platform. These platform processes all use packed-bed chromatography which, by is very nature, are not designed to be SU. When product demand is low, due to the clinical stage or therapeutic use, the OpEx and CapEx of a platform process can become prohibitively high. A SU non-chromatography based purification scheme will be presented. In this purification scheme SU hydrogels replace chromatography and high capacity depth filters take the place of centrifugation. A comparison of the SU process to a traditional platform process will be presented with respect to process yields, clearance of impurities and economics.

Single-use nonchromatographic purification method for antibodies

249th National Meeting (2015)

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