Scale Up and Scale Down of Equipment

Moussa, Amgad

doi:10.1021/bk-2022-1426.ch007

ACS Symposium Series

2022

DOI: 10.1021/bk-2022-1426.ch007

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Scale Up and Scale Down of Equipment

Amgad Moussa

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Cited by 2 publications

References 114 publications

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Design modifications and scale-up of a novel soxhlet apparatus: Optimization of batch extraction of a biofuel oil from Crotalaria juncea seeds

Dutta,

Sarkar

2023

Sustainable Energy Technologies and Assessments

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Design modifications and scale-up of a novel soxhlet apparatus: Optimization of batch extraction of a biofuel oil from Crotalaria juncea seeds

Dutta,

Sarkar

2023

Sustainable Energy Technologies and Assessments

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QbD Approach to Process Characterization and Quantitative Criticality Assessment of Process Parameters

Rege,

Schuster,

Lamerz

et al. 2024

Org. Process Res. Dev.

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The quality-by-design (QbD) approach is widely utilized for developing and validating manufacturing processes for drug substances as well as drug products. This paper discusses the application of the risk-based QbD approach used at F. Hoffmann-La Roche Ltd. for development, optimization, and characterization of drug substance manufacturing processes for small molecules. It presents the evolution of the QbD concept into statistical thinking and development of a quantitative tool, namely, the impact ratio concept, for its successful implementation. The utilization of this approach is illustrated with a case study from the taselisib drug substance manufacturing process. KEYWORDS: quality by design (QbD), quality risk assessment (QRA), process characterization, design of experiment (DoE), critical process parameter (CPP), critical material attribute (CMA), critical quality attribute (CQA), statistics, impact ratio (IR), process performance qualification (PPQ) Article pubs.acs.org/OPRD

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Scale Up and Scale Down of Equipment

Cited by 2 publications

References 114 publications

Design modifications and scale-up of a novel soxhlet apparatus: Optimization of batch extraction of a biofuel oil from Crotalaria juncea seeds

Design modifications and scale-up of a novel soxhlet apparatus: Optimization of batch extraction of a biofuel oil from Crotalaria juncea seeds

QbD Approach to Process Characterization and Quantitative Criticality Assessment of Process Parameters

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