Knowledge management in secondary pharmaceutical manufacturing by mining of data historians—A proof-of-concept study

Meneghetti, Natascia; Facco, Pierantonio; Bezzo, Fabrizio; Himawan, Chrismono; Zomer, Simeone; Barolo, Massimiliano

doi:10.1016/j.ijpharm.2016.03.035

Cited by 15 publications

(8 citation statements)

References 6 publications

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“…Therefore, data from different process levels and distributed locations can be integrated and contextualized with meaningful information. Such knowledge plays an important role in supporting process control and decision making [31]. Future work includes validating the possibility of using this data management strategy to support the design of experiment (DOE).…”

Section: Discussionmentioning

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: Discussionmentioning

confidence: 99%

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

et al. 2018

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“…Following the primary manufacturing stage, pharmaceutical dosage forms are produced at the secondary manufacturing echelon (Meneghetti et al 2016). Dosage forms may include tablets, capsules, suppositories, inhalers, powders or any other form.…”

Section: Technologymentioning

confidence: 99%

Mapping supply dynamics in renewable feedstock enabled industries: A systems theory perspective on ‘green’ pharmaceuticals

Tsolakis

Srai

2018

Oper Manag Res

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This paper provides a multi-stage multi-layer mapping methodology for capturing the macro-level supply chain dynamics that govern industrial systems using renewable feedstocks. The mapping approach combines the Industrial Systems Mapping and System Dynamics principles to systematically capture the interrelations across: (i) institutional players, (ii) sector specialists, (iii) products and intermediates, (iv) production operations, and (v) firms within the supply chain. The interfaces are further explored at four interconnected and mutually interacting theme areas of analysis, namely: (i) renewable chemical feedstocks, (ii) production technologies, (iii) target markets, and (iv) value and economic viability. We demonstrate the applicability of our approach by mapping the dynamics in industrial systems for the production of 'green' pharmaceuticals, particularly via the illustrative case of paracetamol. Through the use of the proposed integrated mapping process the case study demonstrates the principal interrelationships and inter-firm dynamics between the different layers of analysis. Three main drivers are identified that could enhance supply network transformations for improved viability of these developing industrial systems, namely: (i) regulatory conformance with market requirements, (ii) system level feasibility assessment of given renewable feedstocks, and (iii) target market volume demand. The causal feedback elements of the provided mapping technique indicate that it could support the analysis of industrial systems' transformation dynamics enabled by renewable feedstocks. The standardisation of the methodology and its elements provides for an effective visualisation technique with cross-industry relevance.

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“…The Pharmaceutical Industry has many available data, however their analysis and interpretation is complex. The application of data analysis tools is a pivotal example of how Academia and Industry can perform research applied to routine processes, proactively identifying potential areas of improvements (Meneghetti, N., et Al, 2016).…”

Section: Contract Manufacturing Organization (Etpn)mentioning

confidence: 99%

The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage

Panzitta

Bruno²,

Cois³

et al. 2017

International Journal of Pharmaceutics

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Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain. Manufacturing Technology should be acknowledged as a R&D step and as a very important matter during University degree in Pharmacy and related disciplines, promoting collaboration between Academia and Industry, measured during HTA step and rewarded in terms of price and reimbursement. The above elements are not yet properly recognised, and manufacturing technology is taken in to consideration only when a shortage is in place. In a previous work, Panzitta et al. proposed to perform a full technology assessment at the Health Technological Assessment stage, evaluating three main technical aspects of a medicine: manufacturing process, physicochemical properties, and formulation characteristics. In this paper, we develop the concept of manufacturing appraisal, providing a technical overview of upcoming challenges, a risk based approach and an economic picture of shortage costs. We develop also an overall quality concept, not limited to GMP factors but broaden to all elements leading to a robust supply and promoting technical innovation.

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Knowledge management in secondary pharmaceutical manufacturing by mining of data historians—A proof-of-concept study

Cited by 15 publications

References 6 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

Mapping supply dynamics in renewable feedstock enabled industries: A systems theory perspective on ‘green’ pharmaceuticals

The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage

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