Advanced Manufacturing, Modeling And Analytical Tools In Injectable Products.

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Howard Stamato, Maxwell Korang-Yeboah, Jyothi Rangineni, Xiaoming Xu, Robin Bogner

Author Information

Howard Stamato: SSL, Califon, NJ, USA. Howard@StamatoSolutions.com. ORCID
Maxwell Korang-Yeboah: US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Silver Spring, MD, USA. ORCID
Jyothi Rangineni: Fluid Air, A Division of Spraying Systems Co., Napierville, IL, USA. ORCID
Xiaoming Xu: US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research, Silver Spring, MD, USA. ORCID
Robin Bogner: Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT, USA. ORCID

PMID: 40011372 DOI: 10.1007/s11095-025-03815-5

Although great progress has been made in the effectiveness and availability of medicines, there is still more work to do assuring greater access and continuing to advance disease treatments. Recent advances in both the types of treatments that can be developed and the technology to produce, characterize, collect relevant data from, and deliver medicines to patients have accelerated in recent experience. The National Institute for Pharmaceutical Technology and Education assembled representatives from academia, industry, and health authorities to assess progress. This article gives a perspective on recent trends in advanced manufacturing of injectable pharmaceutical products and provides some insight from which pharmaceutical manufacturers may implement valuable improvements based on these technological advances.

advanced manufacturing lyophilization modeling parenteral products process analytical technology

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Humans

Drug Industry

Injections

Pharmaceutical Preparations

Technology, Pharmaceutical

Pharmaceutical Preparations

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