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BCMA-CD19 armored compound CAR T cells in systemic lupus erythematosus: extended follow-up of a phase 1 clinical trial. [PDF]
J Hematol OncolHong M +20 more
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Development of a Chemometric Platform for Mid-Infrared Fermentation Monitoring
Torres-Acosta MA +5 more
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Process analytical technology (PAT) for biopharmaceutical products
Analytical and Bioanalytical Chemistry, 2010The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical technology (PAT) by the pharmaceutical industry.
Anurag Rathore
exaly +3 more sources
Process Analytical Technologies (PAT) in freeze-drying of parenteral products
Pharmaceutical Development and Technology, 2009Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes.
Sajal Manubhai, Patel, Michael, Pikal
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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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Process Analytical Technology (PAT) in Quality Assurance: A Detailed Review
International Journal of Pharmaceutical Sciences and Nanotechnology, 2022Process Analytical Technology (PAT) is a proactive initiative published by the Food and Drug Administration so as to overcome the conventional way of batch testing. As per the documented guideline it can be stated as a system for designing, analyzing, and controlling pharmaceutical manufacturing through the timely measurement of critical quality ...
Esha Bhavin Shah, Anuradha Gajjar
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Chemometrics in bioprocess engineering: process analytical technology (PAT) applications
Chemometrics and Intelligent Laboratory Systems, 2004Abstract The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies.The Food and Drug Administration's (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new ...
João A Lopes, JOSÉ Cardoso Menezes
exaly +2 more sources
Spectroscopy for Process Analytical Technology (PAT)
2010Spectroscopic sensors play a key role in process analytical technology. Such sensors can be interfaced to almost any type of manufacturing process, and by rapid, precise, and nondestructive spectroscopic analysis, it is possible to predict analyte concentration, quantify physical parameters, or fingerprint process streams and raw materials.
Skibsted, Erik, Engelsen, Søren Balling
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CHEMOMETRIC PROCESS ANALYTICAL TECHNOLOGY (PAT) APPLICATIONS IN BIOPROCESS ENGINEERING
IFAC Postprint Volumes IPPV / International Federation of Automatic Control, 2005Abstract The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies. The Food and Drug Administration's (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new ...
João A Lopes, JOSÉ Cardoso Menezes
exaly +2 more sources