Integrated process performance assessment considering uncertainty in biopharmaceutical manufacturing operations

Casola, Gioele; Siegmund, Christian; Mattern, M.; Sugiyama, Hirokazu

doi:10.1016/b978-0-444-63965-3.50373-1

Cited by 1 publication

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“…As a case study, the methodology was applied to a CIP/SIP process in a commercial facility for biopharmaceutical DP manufacturing. The authors have presented a previous version of the methodology in part in a six‐page conference proceedings paper, but this article presents the complete work with full details.…”

Section: Introductionmentioning

confidence: 99%

Uncertainty‐conscious methodology for process performance assessment in biopharmaceutical drug product manufacturing

et al. 2017

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This work presents an uncertainty‐conscious methodology for the assessment of process performance—for example, run time—in the manufacturing of biopharmaceutical drug products. The methodology is presented as an activity model using the type 0 integrated definition (IDEF0) functional modeling method, which systematically interconnects information, tools, and activities. In executing the methodology, a hybrid stochastic–deterministic model that can reflect operational uncertainty in the assessment result is developed using Monte Carlo simulation. This model is used in a stochastic global sensitivity analysis to identify tasks that had large impacts on process performance under the existing operational uncertainty. Other factors are considered, such as the feasibility of process modification based on Good Manufacturing Practice, and tasks to be improved is identified as the overall output. In a case study on cleaning and sterilization processes, suggestions were produced that could reduce the mean total run time of the processes by up to 40%. © 2017 American Institute of Chemical Engineers AIChE J, 64: 1272–1284, 2018

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Section: Introductionmentioning

confidence: 99%