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Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing

Annual Review of Chemical and Biomolecular Engineering, 2018
The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety ...
Christopher L, Burcham   +2 more
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Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

Journal of Pharmaceutical Sciences, 2015
This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product.
Allan S, Myerson   +4 more
openaire   +3 more sources

Regulatory and Quality Considerations for Continuous Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

Journal of Pharmaceutical Sciences, 2015
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy ...
Gretchen, Allison   +17 more
openaire   +3 more sources

Optimal Campaign Continuous Manufacturing

Industrial & Engineering Chemistry Research, 2015
Campaign continuous manufacturing (CM), characterized by relatively short operational windows such as a few weeks, is being explored as an alternative to traditional batch-wise manufacturing in the pharmaceutical industry. However, optimal operation in campaign CM can be challenging because of the significance of startup and shutdown phases, which can ...
Ali M. Sahlodin, Paul I. Barton
openaire   +1 more source

Continuous flow manufacturing

IEEE/SEMI International Symposium on Semiconductor Manufacturing Science, 2002
CFM (continuous-flow manufacturing) combines total quality control, total people involvement, and the elimination of waste to ensure continuous attention to enhancements of manufacturing efficiency. The author provides an overview of CFM and suggests six generic areas of every manufacturing line where the CFM approach can be used.
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Continuous Flow Manufacturing

1995
Strategies for a new era the modernization vision the continuous flow factory vision automation for the continuous flow factory overcoming the challenges of automation comparing continuous flow and traditional factories information systems for the continuous flow factory taking action and realizing the gains consolidating the gains of continuous flow ...
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Continuous Feeding-Blending in Pharmaceutical Continuous Manufacturing

2020
Pharmaceutical continuous manufacturing has steadily progressed from the proof of concept to the pilot and industrial production in the past two decades, some of which have recently been approved by the US Food and Drug Administration (FDA), resulting in a greater demand on experience in process design and operation in pharmaceutical continuous ...
Qinglin Su   +2 more
openaire   +1 more source

Continuous integrated manufacturing of therapeutic proteins

Current Opinion in Biotechnology, 2018
With the growth of our understanding of biopharmaceutical processes, a transition from classical batch to continuous integrated manufacturing of therapeutic proteins is taking place across laboratory, clinical and commercial scales. Encouraged by regulatory authorities, this transition is favoured by new emerging technologies as well as by the ...
Daniel Johannes, Karst   +2 more
openaire   +2 more sources

Continuous improvement in British manufacturing

Technovation, 1993
Abstract Continuous improvement (CI) — sustained, focused, company-wide incremental innovation — is increasingly recognized as a powerful potential source of competitive advantage. Experience — particularly but not exclusively in Japan — suggests that major gains in quality, flexibility and cost saving can result from CI programmes, and as a result ...
John Bessant   +3 more
openaire   +1 more source

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