Identifying Innovative Technologies to Advance Pharmaceutical Manufacturing

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Emerging technologies have the potential to modernize pharmaceutical manufacturing and advance the quality of drug products. A 2021 report from the National Academies of Sciences, Engineering, and Medicine (the National Academies) identified these innovative technologies, including manufacturing processes, control and testing strategies, and product technologies. The report, Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations, also discussed technical and regulatory challenges to implementing these technologies and provided suggestions for overcoming some of those issues. A virtual dissemination workshop titled Innovations in Pharmaceutical Manufacturing on the Horizon was hosted by the National Academies on October 28-29, 2021, and provided a venue for discussing the 2021 National Academies report's recommendations and a platform for members of the report committee to reflect on the study. This Proceedings of a Workshop-in Brief summarizes the presentations and discussions that took place during the dissemination workshop.

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12 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-68671-7
DOI: https://doi.org/10.17226/26539

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National Academies of Sciences, Engineering, and Medicine. 2022. Innovations in Pharmaceutical Manufacturing on the Horizon: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.

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In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further.

At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years.

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120 pages · 8.5 x 11 · paperback
ISBN Paperback: 0-309-08867-4
ISBN Ebook: 0-309-10480-7
DOI: https://doi.org/10.17226/26009

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National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press.

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Modernizing pharmaceutical manufacturing is seen as offering a solution to drug shortages and vulnerabilities of drug supply chains, but there are technical, regulatory, and other barriers to doing so. The virtual workshop Barriers to Innovations in Pharmaceutical Manufacturing held on June 2-3, 2020, provided a venue for discussing barriers to innovations in the pharmaceutical industry and included sessions on integration, intensification, and control; innovative processing technologies; and disruptive technologies and convergent innovations. It was hosted by the National Academies of Sciences, Engineering, and Medicine Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing and served as the second information-gathering activity to assist the committee with producing its consensus report. This Proceedings of a Workshop-in Brief summarizes the presentations and discussions that took place during the workshop.

Publication information

12 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-68189-8
DOI: https://doi.org/10.17226/25907

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National Academies of Sciences, Engineering, and Medicine. 2020. Barriers to Innovations in Pharmaceutical Manufacturing: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.

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Global pandemics and the increasing severity and frequency of natural disasters have highlighted the vulnerabilities of drug supply chains and have underscored the need to modernize pharmaceutical manufacturing. The workshop Innovations in Pharmaceutical Manufacturing held in Washington, DC, on February 27-28, 2020, provided a venue for discussing potential technologies that are on the horizon in the next 5-10 years in the pharmaceutical industry. It was hosted by the National Academies of Sciences, Engineering, and Medicine Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing and served as its first information-gathering activity for this committee. This Proceedings of a Workshop-in Brief summarizes the presentations and discussions that took place during the workshop.

Publication information

12 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-67807-2
DOI: https://doi.org/10.17226/25814

Suggested citation

National Academies of Sciences, Engineering, and Medicine. 2020. Innovations in Pharmaceutical Manufacturing: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.

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