Process analytical technology (PAT) for biopharmaceuticals [PDF]
Biotechnology Journal, 2011 Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production. The recommended analytical tools for building in quality, multivariate data analysis, mechanistic modeling, novel models for interpretation of systems biology data and ...
Glassey J +6 more
openaire +7 more sources
On the Use of Temperature Measurements as a Process Analytical Technology (PAT) for the Monitoring of a Pharmaceutical Freeze-Drying Process [PDF]
Pharmaceutics, 2023 The measurement of product temperature is one of the methods that can be adopted, especially in the pharmaceutical industry, to monitor the freeze-drying process and to obtain the values of the process parameters required by mathematical models useful ...
Alberto Vallan +3 more
doaj +2 more sources
In-process analytics for IVT mRNA manufacturing: from process understanding to advanced process control [PDF]
Frontiers in Bioengineering and BiotechnologyRNA therapeutics are expanding rapidly, driving demand for manufacturing processes that can keep pace with clinical translation. Because mRNA yield and impurity profiles are jointly influenced by upstream plasmid DNA (pDNA) preparation and the in vitro ...
Naryeong Kim +3 more
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Exploiting Fluorescent Reporter Molecules for Process Analytical Technology (PAT)
CHIMIA, 2009 Process Analytical Technology (PAT) launched by the U.S. Food and Drug Administration (FDA) aims to ensure the quality of pharmaceutical products. One important tool to obtain a deeper process understanding is the use of modern real-time process
Tobias Broger +3 more
doaj +3 more sources
In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME) [PDF]
Pharmaceutics, 2018 This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework.
Walkiria Schlindwein +5 more
doaj +2 more sources
Experimental design of a film flow cleaning rig equipped with in-line process analytical technology (PAT) tool for real-time monitoring [PDF]
HeliyonThe main purpose of this research was to develop an experimental film flow cleaning rig that can be combined with Process analytical technology (PAT) tools to reduce cleaning time and costs. Here, we show that the use of in-line UV–Vis was successful for
Marina Steiner-Browne +2 more
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Current PAT Landscape in the Downstream Processing of Biopharmaceuticals [PDF]
Analytical Science AdvancesProtein‐based therapeutics have revolutionized modern medicine, addressing complex diseases with unprecedented specificity and efficacy. The rising demand for biologics has driven the evolution of biomanufacturing practices to ensure consistent quality ...
Pavithra Sathiyapriyan +6 more
doaj +2 more sources
Symposium on Process Analytical Technology (PAT) at ILMAC Lausanne 2018
CHIMIA, 2018 David Spichiger, Tobias Merz
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Non-invasive instrumental analytical methods in modern pharmaceutical technology [PDF]
Farmacja Polska, 2020 The purpose of this work is the evaluation of the state of knowledge in the scope of the possibility of using of non-invasive analytical methods in the implementation of Process Analytical Technology strategy, which is currently recommended by worldwide ...
Joanna Ronowicz, Natalia Piekuś-Słomka
doaj +1 more source
Foods, 2021 Enzymatic degumming is a well established process in vegetable oil refinement, resulting in higher oil yield and a more stable downstream processing compared to traditional degumming methods using acid and water. During the reaction, phospholipids in the
Jakob Forsberg +3 more
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