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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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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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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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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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The Role of Process Analytical Technology (PAT) in Biologics Development
2022Dhanuka P. Wasalathanthri +1 more
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Process analytical technology (PAT) needs and applications in the bioprocess industry
2006Process analytical technologies have been applied to manufacturing processes (pulp and paper, chemical and petroleum) for decades. Recently, the US Food and Drug Administration (FDA) has, however, re-defined the phrase and implemented it into an initiative focusing on improving several aspects of the pharmaceutical industry. The European Agency for the
Känsäkoski, Markku +9 more
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