Chapter 11 Downstream Processing - Biomanufacturing
Intermediate purification: the removal of bulk contaminants, including host cell proteins and adventitious viruses as well as any potential contaminating leachates from other in-process materials Microfiltration: filtration that can be used at the …
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Chapter 11 Downstream Processing - Biomanufacturing
biomanufacturing.orgTable 11-1: Commonly employed downstream processing methods (adapted from Kemp and O’Neil 2003) Processing Method Attributes Benefits Limitations Clarification: (often considered part of the upstream processing train) Sedimentation- based Clarification continuous centrifugation capable of handling very large harvest volumes open process-
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biomanufacturing.orgcontainers (pharmaceutical container/closure). This operation exposes the sterile product to the environment, equipment, and manipulative technique of the operators until it can be sealed in the dose container; therefore, this operation is performed with a minimum exposure
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biomanufacturing.orguse of airflow booths and following cleaning protocol • explain the in-process controls for assessing media components • illustrate the major types of bioreactors and associated instruments used for upstream biomanufacturing • evaluate situations in order to make appropriate aseptic decisions
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