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Systematic assessment of process analytical technologies for biologics
Biotechnology and Bioengineering, 2021AbstractThe application of process analytical technology (PAT) for biotherapeutic development and manufacturing has been employed owing to technological, economic, and regulatory advantages across the industry. Typically, chromatographic, spectroscopic, and/or mass spectrometric sensors are integrated into upstream and downstream unit operations in in ...
Christopher Gillespie +6 more
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Trends in process analytical technology
Analytical Methods, 2010Since the promotion of Process Analytical Technology (PAT) by the U.S. Food and Drug Administration (FDA), there has been a flurry of activities happening across related fields. This excitement permeates regulatory agencies, professional societies, academia and industry worldwide.
Wee Chew, Paul Sharratt
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2010
Contributors. Preface. List of Abbreviations. Process Analytical Chemistry: Introduction and Historical Prespective. Dr. Ernest Baughman. Implementation of Process Analytical Technologies. Dr. Gert Thurau & Dr. Robert Guenard. Merck and Co., Inc. Near-Infrared Spectroscopy for Process Analytical Chemistry: Theory, Technology and Implementation.
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Contributors. Preface. List of Abbreviations. Process Analytical Chemistry: Introduction and Historical Prespective. Dr. Ernest Baughman. Implementation of Process Analytical Technologies. Dr. Gert Thurau & Dr. Robert Guenard. Merck and Co., Inc. Near-Infrared Spectroscopy for Process Analytical Chemistry: Theory, Technology and Implementation.
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Process Analytical Technology: An Investment in Process Knowledge
Organic Process Research & Development, 2005Process analytical technology (PAT) is fast becoming an integral part of many active pharmaceutical ingredient (API) production facilities. The incorporation of early PAT devices, such as pH probes for example, was shown to increase process efficiency and safety by acting on data in real time and by eliminating sampling.
Frank Sistare +2 more
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Machine learning algorithms for process analytical technology
2016 World Congress on Industrial Control Systems Security (WCICSS), 2016Increased globalisation and competition are drivers for process analytical technologies (PAT) that enable seamless process control, greater flexibility and cost efficiency in the process industries. The paper will discuss process modelling and control for industrial applications with an emphasis on solutions enabling the real-time data analytics of ...
Niall O' Mahony +4 more
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Process analytical technology (PAT) for biopharmaceutical products
Analytical and Bioanalytical Chemistry, 2010The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical technology (PAT) by the pharmaceutical industry.
A S, Rathore, R, Bhambure, V, Ghare
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Use of HPLC as an Enabler of Process Analytical Technology in Process Chromatography
Analytical Chemistry, 2018Online monitoring of product quality attributes using high resolution analytical tools is a prerequisite for implementation of process analytical technology (PAT) and thereby ensuring product quality and consistency. Online high-performance liquid chromatography (HPLC) has been established for real time monitoring of product quality attributes. However,
Anamika Tiwari +3 more
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Process Analytical Technology in Continuous Crystallization
2020This chapter discusses the topic of process analytical technology (PAT) in the context of continuous manufacturing and crystallization. The chapter starts with the introduction of the quality by design (QbD) concept, which heavily relies on the application of PAT tools for its implementation.
L. L. Simon, E. Simone
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Spectroscopy for Process Analytical Technology (PAT)
2010Spectroscopic sensors play a key role in process analytical technology. Such sensors can be interfaced to almost any type of manufacturing process, and by rapid, precise, and nondestructive spectroscopic analysis, it is possible to predict analyte concentration, quantify physical parameters, or fingerprint process streams and raw materials.
Skibsted, Erik, Engelsen, Søren Balling
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Process analytical technology in Downstream-Processing of Drug Substances– A review
International Journal of PharmaceuticsProcess Analytical Technology (PAT) has revolutionized pharmaceutical manufacturing by providing real-time monitoring and control capabilities throughout the production process. This review paper comprehensively examines the application of PAT methodologies specifically in the production of solid active pharmaceutical ingredients (APIs). Beginning with
Peter, Neugebauer +5 more
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