Thomas F. O'Connor , Sharmista Chatterjee , Johnny Lam , Dolores Hernán Pérez de la Ossa , Leticia Martinez-Peyrat , Marcel H.N. Hoefnagel , Adam C. Fisher
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An important consideration of implementing a process model is determining the impact of the model on the quality of the product and the risks associated with model maintenance over the product lifecycle. Several regulatory documents address risk-based considerations for process models. This work discusses existing risk-based frameworks for model validation and lifecycle maintenance that could aid the adoption of process models in pharmaceutical manufacturing. Hypothetical case studies illustrate the implications of applying a model risk framework to facilitate model validation and lifecycle maintenance in the manufacture of pharmaceuticals and biological products.</p></div>","PeriodicalId":14280,"journal":{"name":"International Journal of Pharmaceutics: X","volume":"8 ","pages":"Article 100274"},"PeriodicalIF":5.2000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S259015672400046X/pdfft?md5=9ffcd3019bddcac26895281a73457971&pid=1-s2.0-S259015672400046X-main.pdf","citationCount":"0","resultStr":"{\"title\":\"An examination of process models and model risk frameworks for pharmaceutical manufacturing\",\"authors\":\"Thomas F. O'Connor , Sharmista Chatterjee , Johnny Lam , Dolores Hernán Pérez de la Ossa , Leticia Martinez-Peyrat , Marcel H.N. Hoefnagel , Adam C. Fisher\",\"doi\":\"10.1016/j.ijpx.2024.100274\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Process models are a growing tool for pharmaceutical manufacturing process design and control. The Industry 4.0 paradigm promises to increase the amount of data available to understand manufacturing processes. Tools such as Artificial Intelligence (AI) might accelerate process development and allow better predictions of process trajectories. Several examples of process improvements realized through the application of process models have been shown in lyophilization, chromatography, fluid bed drying, bioreactor control, continuous direct compression, and wet granulation. An important consideration of implementing a process model is determining the impact of the model on the quality of the product and the risks associated with model maintenance over the product lifecycle. Several regulatory documents address risk-based considerations for process models. This work discusses existing risk-based frameworks for model validation and lifecycle maintenance that could aid the adoption of process models in pharmaceutical manufacturing. Hypothetical case studies illustrate the implications of applying a model risk framework to facilitate model validation and lifecycle maintenance in the manufacture of pharmaceuticals and biological products.</p></div>\",\"PeriodicalId\":14280,\"journal\":{\"name\":\"International Journal of Pharmaceutics: X\",\"volume\":\"8 \",\"pages\":\"Article 100274\"},\"PeriodicalIF\":5.2000,\"publicationDate\":\"2024-08-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S259015672400046X/pdfft?md5=9ffcd3019bddcac26895281a73457971&pid=1-s2.0-S259015672400046X-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Pharmaceutics: X\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S259015672400046X\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutics: X","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S259015672400046X","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
An examination of process models and model risk frameworks for pharmaceutical manufacturing
Process models are a growing tool for pharmaceutical manufacturing process design and control. The Industry 4.0 paradigm promises to increase the amount of data available to understand manufacturing processes. Tools such as Artificial Intelligence (AI) might accelerate process development and allow better predictions of process trajectories. Several examples of process improvements realized through the application of process models have been shown in lyophilization, chromatography, fluid bed drying, bioreactor control, continuous direct compression, and wet granulation. An important consideration of implementing a process model is determining the impact of the model on the quality of the product and the risks associated with model maintenance over the product lifecycle. Several regulatory documents address risk-based considerations for process models. This work discusses existing risk-based frameworks for model validation and lifecycle maintenance that could aid the adoption of process models in pharmaceutical manufacturing. Hypothetical case studies illustrate the implications of applying a model risk framework to facilitate model validation and lifecycle maintenance in the manufacture of pharmaceuticals and biological products.
期刊介绍:
International Journal of Pharmaceutics: X offers authors with high-quality research who want to publish in a gold open access journal the opportunity to make their work immediately, permanently, and freely accessible.
International Journal of Pharmaceutics: X authors will pay an article publishing charge (APC), have a choice of license options, and retain copyright. Please check the APC here. The journal is indexed in SCOPUS, PUBMED, PMC and DOAJ.
The International Journal of Pharmaceutics is the second most cited journal in the "Pharmacy & Pharmacology" category out of 358 journals, being the true home for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for drugs, vaccines and biologicals, including their design, manufacture and evaluation. This includes evaluation of the properties of drugs, excipients such as surfactants and polymers and novel materials. The journal has special sections on pharmaceutical nanotechnology and personalized medicines, and publishes research papers, reviews, commentaries and letters to the editor as well as special issues.