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Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review [PDF]
Molecules, 2022 The release of the FDA’s guidance on Process Analytical Technology has motivated and supported the pharmaceutical industry to deliver consistent quality medicine by acquiring a deeper understanding of the product performance and process interplay.
Tibor Casian +5 more
doaj +2 more sources
Levothyroxine Variations by Process Analytical Technology. [PDF]
Contact Context, 2022 Intra-lot and inter-lot variability in the spectra of levothyroxine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). Two vials of 12 vials sampled from Athenex lot AFN102 appeared 10.1 and 9.1 SDs from the center of the rest of the vials on the DQS FTNIR screening assay.
Isaacs JT +5 more
europepmc +3 more sources
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
Optofluidic force induction as a process analytical technology. [PDF]
Anal Bioanal Chem, 2023 Abstract Manufacturers of nanoparticle-based products rely on detailed information about critical process parameters, such as particle size and size distributions, concentration, and material composition, which directly reflect the quality of the final product.
Šimić M +3 more
europepmc +4 more sources
A FT-NIR Process Analytical Technology Approach for Milk Renneting Control [PDF]
Foods, 2021 The study proposes a process analytical technology (PAT) approach for the control of milk coagulation through near infrared spectroscopy (NIRS), computing multivariate statistical process control (MSPC) charts, based on principal component analysis (PCA).
Silvia Grassi +5 more
doaj +2 more sources
Editorial: Freeze-Drying and Process Analytical Technology for Pharmaceuticals [PDF]
Frontiers in Chemistry, 2018 Davide Fissore, Timothy McCoy
doaj +2 more sources
A NIR-Based Study of Desorption Kinetics during Continuous Spin Freeze-Drying
Pharmaceutics, 2021 The pharmaceutical industry is progressing toward the development of more continuous manufacturing techniques. At the same time, the industry is striving toward more process understanding and improved process control, which requires the implementation of
Laurens Leys +6 more
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Gas Antisolvent Approach for the Precipitation of α -Methoxyphenylacetic Acid – ( R )-1-Cyclohexylethylamine Diateromeric Salt [PDF]
Chemical and Biochemical Engineering Quarterly, 2017 One of the major drawbacks of diastereomeric salt precipitation based enantioseparation is the time and solvent requirement of crystallization. In the gas antisolvent (GAS) approach, supercritical carbon dioxide is applied as an antisolvent, and the ...
A. Zodge +6 more
doaj +1 more source
Scientific Reports, 2023 The osteochondral interface is a thin layer that connects hyaline cartilage to subchondral bone. Subcellular elemental distribution can be visualised using synchrotron X-ray fluorescence microscopy (SR-XFM) (1 μm).
Xiwei Fan +6 more
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C, 2022 Storage is still limiting the implementation of hydrogen as an energy carrier to integrate the intermittent operation of renewable energy sources.
Jose A. Villajos
doaj +1 more source