Pharmaceutical Industry

Chen, Wenqian; Park, Sung‐Joon; Cheng, Thomas N.H.; Lau, Nicholas Wai Hoi; Khaw, Liang Fa; Lee‐Lane, Dan; Chen, Xizhong; Şeşen, Muhsincan

doi:10.1002/9781119695868.ch12

Cited by 5 publications

(3 citation statements)

References 141 publications

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“…We show how this provided data for a robust control strategy that relies on parametric control throughout the continuous operation followed by defined batch release of the drug substance intermediate. Such a control strategy is advantageous operationally and, in our view, also holds potential for future developments that live up to some of the promise of continuous manufacturing, 35,36 including closed-loop control with PAT 37−39 and real-time release. 40 In providing the details of the characterization, we highlight several aspects that are unique to characterizing an integrated CM process compared to a more traditional batch process: namely, the process parameters selected for study, the interconnectivity of these process parameters, the added temporal element of many of these process parameters, and the experimental setup and data collected for each characterization experiment.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Continuous Process for Manufacturing Apremilast. Part II: Process Characterization to Establish a Parametric Control Strategy

Griffin,

Hsieh,

Avci

et al. 2024

Org. Process Res. Dev.

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This is Part II of a series on the development and characterization of an integrated continuous manufacturing (CM) process developed for the penultimate step in the synthesis of the drug substance Apremilast (Otezla). Part I gives the development history and highlights the achieved process intensification. Here, we describe the process characterization (PC) undertaken. In doing so, we point out aspects of characterization that are unique to an integrated CM process and give our strategy for navigating PC in this scenario. Moreover, we provide data that support a robust control strategy which relies on parametric control only (i.e., no inprocess controls) followed by batch release of the produced Apremilast drug substance intermediate. Such a control strategy is advantageous as it minimizes divert-to-waste loss and operational costs.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Continuous Process for Manufacturing Apremilast. Part II: Process Characterization to Establish a Parametric Control Strategy

Griffin,

Hsieh,

Avci

et al. 2024

Org. Process Res. Dev.

View full text Add to dashboard Cite

show abstract

“…However, the study hasn’t mentioned how the regulatory scheme incentivizes investment in the pharmaceutical industry. Chen et al [ 18 ] provided a comprehensive assessment of the vital elements of Pharma 4.0 concerning the regulatory driving factors for smart manufacturing, difficulties, and potential future advances. However, no quantitative or qualitative analysis was used to prioritize or develop a relationship-building framework to evaluate those vital elements.…”

Section: Introductionmentioning

confidence: 99%

Assessing the critical success factors for implementing industry 4.0 in the pharmaceutical industry: Implications for supply chain sustainability in emerging economies

Debnath,

Shakur,

Bari

et al. 2023

PLoS ONE

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The emerging technologies of Industry 4.0 (I4.0) are crucial to incorporating agility, sustainability, smartness, and competitiveness in the business model, enabling long-term sustainability practices in the pharmaceutical supply chain (PSC). By leveraging the latest technologies of I4.0, pharmaceutical companies can gain real-time visibility into their supply chain (SC) operations, allowing them to make data-driven decisions that improve SC performance, efficiency, resilience, and sustainability. However, to date, no research has examined the critical success factors (CSFs) that enable the pharmaceutical industry to adopt I4.0 successfully to enhance overall SC sustainability. This study, therefore, analyzed the potential CSFs for adopting I4.0 to increase all facets of sustainability in the PSC, especially from the perspective of an emerging economy like Bangladesh. Initially, sixteen CSFs were identified through a comprehensive literature review and expert validation. Later, the finalized CSFs were clustered into three relevant groups and analyzed using a Bayesian best-worst method (BWM)-based multi-criteria decision-making (MCDM) framework. The study findings revealed that "sufficient investment for technological advancement", "digitalized product monitoring and traceability", and "dedicated and robust research and development (R&D) team" are the top three CSFs to adopt I4.0 in the PSC. The study’s findings can aid industrial practitioners, managers, and policymakers in creating effective action plans for efficiently adopting I4.0 in PSC to avail of its competitive benefits and ensure a sustainable future for the pharmaceutical industry.

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