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Dorresteijn, R. C.; Wieten, G.; Santen, P. T. E. van; Philippi, M. C.; Gooijer, C.D. de; Tramper, J.; Beuvery, E. C.

doi:10.1023/a:1007923820231

Cited by 6 publications

(1 citation statement)

References 48 publications

(41 reference statements)

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“…The ISA-88 Batch Control Standard [4][5][6] is an international standard addressing batch process control, which has already been implemented in other industries for years. Therefore, adapting this industrial standard into pharmaceutical manufacturing could provide a design philosophy for describing equipment, material, personnel, as well as reference models [7,8]. This recipe-based execution could work as a hierarchical data structure for the assembly of data from the control system, process analytical technology PAT tools, and off-line measurement devices.…”

Section: Introductionmentioning

confidence: 99%

A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line

et al. 2018

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As the pharmaceutical industry seeks more efficient methods for the production of higher value therapeutics, the associated data analysis, data visualization, and predictive modeling require dependable data origination, management, transfer, and integration. As a result, the management and integration of data in a consistent, organized, and reliable manner is a big challenge for the pharmaceutical industry. In this work, an ontological information infrastructure is developed to integrate data within manufacturing plants and analytical laboratories. The ANSI/ISA-88.01 batch control standard has been adapted in this study to deliver a well-defined data structure that will improve the data communication inside the system architecture for continuous processing. All the detailed information of the lab-based experiment and process manufacturing, including equipment, samples and parameters, are documented in the recipe. This recipe model is implemented into a process control system (PCS), data historian, as well as Electronic Laboratory Notebook (ELN) system. Data existing in the recipe can be eventually exported from this system to cloud storage, which could provide a reliable and consistent data source for data visualization, data analysis, or process modeling.

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Section: Introductionmentioning

confidence: 99%

A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line

et al. 2018

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Properties of hydrodynamic J-type countercurrent chromatography for protein separation using aqueous two-phase systems: With special reference to constructing conical columns

Ding

Zhao

et al. 2017

Journal of Chromatography A

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Monitoring of Submerged Bioprocesses

Vaidyanathan

Macaloney

Vaughan

et al. 1999

Critical Reviews in Biotechnology

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Monitoring is an important exercise in the operation of submerged bioprocesses and is a subject that has attracted intense research activity in recent years. In order to achieve optimal production or conversion, the factors that influence the performance of a bioprocess should be measured, preferably on-line, so that the process can be monitored in real-time and appropriate control or remedial action implemented. Such measurements can be achieved either in situ or ex situ. Ideally, in situ approaches are desirable. Where such an option is difficult to implement, ex situ approaches with appropriate sample handling techniques can be employed. In cases where direct analytical information is not available, inferential approaches can be adopted. In addition, analytical information not yet accessible on-line can be obtained off-line. Computational techniques have enabled the compilation of measurement data before utilizing the information for process diagnosis. Current developments in the different measurement technologies are presented with a critical assessment of their potential application in industrial production or process development.

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Untitled

Cited by 6 publications

References 48 publications

A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line

A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line

Properties of hydrodynamic J-type countercurrent chromatography for protein separation using aqueous two-phase systems: With special reference to constructing conical columns

Monitoring of Submerged Bioprocesses

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