BIOT 76 |
| Purification of protein biopharmaceuticals often consists of multiple chromatography steps. Evaluating the capacity of each chromatography step for removal of process related impurities including host cell proteins (HCP) is essential in assurance of process consistency and product safety. Host cell derived proteins are a highly complex mixture of a variety of proteins. A common approach to demonstrating HCP clearance ability is to spike in high levels of HCP from upstream process steps and then demonstrate log clearance of these impurities as is done to demonstrate viral clearance ability. As will be detailed in this presentation, this approach can be erroneous as a large proportion of the HCPs cleared are not relevant to that particular downstream unit operation. This presentation will explore alternative strategies to demonstrate robustness of a downstream process for demonstrating clearance of relevant HCP species. Information obtained from process characterization studies will be used towards an improved approach to HCP clearance validation. A case study involving three chromatography steps will be presented. |
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Downstream Processing: Advances in Chromatography
8:00 AM-11:00 AM, Monday, August 20, 2007 BCEC -- 107 A/B, Oral
Division of Biochemical Technology |