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Reaction Chemistry & Engineering, 2022
Process analytical technology (PAT) applications pertaining to Pfizer's Flexible API Supply Technology (FAST) initiative.
Courtney N. Talicska +8 more
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Process analytical technology (PAT) applications pertaining to Pfizer's Flexible API Supply Technology (FAST) initiative.
Courtney N. Talicska +8 more
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Journal of Pharmaceutical Sciences, 2008
Terahertz (THz) spectroscopy and chemometric analysis of resultant absorption spectra in the 30-500 cm(-1) range has been applied to perform quantitative determination of both active ingredient and excipient concentrations of tablets. Tests were performed on a series of tablets composed of various concentrations and processes of theophylline formulated
Huiquan, Wu +3 more
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Terahertz (THz) spectroscopy and chemometric analysis of resultant absorption spectra in the 30-500 cm(-1) range has been applied to perform quantitative determination of both active ingredient and excipient concentrations of tablets. Tests were performed on a series of tablets composed of various concentrations and processes of theophylline formulated
Huiquan, Wu +3 more
openaire +2 more sources
Process analytical technology (PAT) for CGT: User requirements specifications
Process analytical technology (PAT) integrates analytical technologies into the biomanufacturing process to achieve timely measurement of process parameters and product quality attributes to ensure product quality. CGTs stand to benefit greatly from employing PAT, but with unique critical quality attributes, complex mechanisms of action and ...Benjamin Ross-Johnsrud +14 more
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2020
Monoclonal antibodies (mAbs) are key molecules in biopharmaceutical manufacturing with important therapeutic use such as anticancer drugs. Mammalian cells serve as production hosts for mAbs. However, mammalian cell culture processes are complex and development timelines for new processes are long.
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Monoclonal antibodies (mAbs) are key molecules in biopharmaceutical manufacturing with important therapeutic use such as anticancer drugs. Mammalian cells serve as production hosts for mAbs. However, mammalian cell culture processes are complex and development timelines for new processes are long.
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Emerging process analytical technology (PAT) for characterization of freeze‐drying processes
Chemie Ingenieur Technik, 2022A. Juckers +3 more
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Journal of Korean Pharmaceutical Sciences, 2007
The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products ...
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The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products ...
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Application of Raman spectroscopy to process analytical technology (PAT)
Problems of Biological Medical and Pharmaceutical Chemistry, 2020V.V. Tihonova, A.S. Saushkina
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Process Analytical Technology (PAT) and Multivariate Methods for Downstream Processes
Current Biochemical Engineering, 2015N.N. Misra, Carl Sullivan, P.J. Cullen
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