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Process Analytical Technology (PAT) Model Lifecycle Management
Spectroscopy, 2023Many applications of process analytical technologies (PAT) use spectroscopic measurements that are based on prediction models. The accuracy of the models can be affected by a number of factors such as aging equipment, slight changes in the active pharmaceutical ingredient (API) or excipients, or previously unidentified process variations.
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PAT – PROCESS ANALYTICAL TECHNOLOGY IN CULTIVATION PROCESSES WITH RECOMBINANT ESCHERICHIA COLI
IFAC Proceedings Volumes, 2007Abstract An extensive monitoring system is build up to fully automate and scan production processes of recombinant Escherichia coli for optimal process performance. It is based on in-line, on-line and at-line measurements for substrates and products.
C. Kaiser +4 more
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Biotechnology and Bioengineering, 2009
AbstractImplementing real‐time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: “variability is managed by the process” and “product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other ...
E K, Read +5 more
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AbstractImplementing real‐time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: “variability is managed by the process” and “product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other ...
E K, Read +5 more
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Process Analytical Technologies (PAT)—the impact for Process Systems Engineering
2008Abstract With the increasing take-up of Process Analytical Technologies (PAT) by the pharmachem, bio-pharma, specialty chemicals and materials manufacturing industries there is a critical need for robust data verification, particularly as this information is being included in real-time control or at least advisory feedback applications. In particular
Chen ZP, Lovett D, Morris J
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Bioresource Technology, 2013
The use of near infrared spectroscopy was investigated as a process analytical technology to monitor the amino acids concentration profile during hydrolysis process of Cornu Bubali. A protocol was followed, including outlier selection using relationship plot of residuals versus the leverage level, calibration models using interval partial least squares
Zhisheng, Wu +6 more
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The use of near infrared spectroscopy was investigated as a process analytical technology to monitor the amino acids concentration profile during hydrolysis process of Cornu Bubali. A protocol was followed, including outlier selection using relationship plot of residuals versus the leverage level, calibration models using interval partial least squares
Zhisheng, Wu +6 more
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Development of Process Analytical Technology (PAT) methods for controlled release pellet coating
European Journal of Pharmaceutics and Biopharmaceutics, 2014This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps,
P, Avalle +6 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
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Critical Reviews in Analytical Chemistry
The field of Process Analytical Technology (PAT) encompasses the utilization of real-time and in-process analytical tools, the analysis and interpretation of the data, and the utilization of this data to control the process (e.g. product consistency).
Alagappan, Shanmugam +2 more
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The field of Process Analytical Technology (PAT) encompasses the utilization of real-time and in-process analytical tools, the analysis and interpretation of the data, and the utilization of this data to control the process (e.g. product consistency).
Alagappan, Shanmugam +2 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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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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