Results 281 to 290 of about 130,011 (340)

Process analytical technology (PAT) for biopharmaceutical products

Analytical and Bioanalytical Chemistry, 2010
The "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.
A S, Rathore, R, Bhambure, V, Ghare
openaire   +2 more sources

Process Analytical Technology (PAT) in Quality Assurance: A Detailed Review

International Journal of Pharmaceutical Sciences and Nanotechnology, 2022
Process 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
openaire   +1 more source

Process Analytical Technologies (PAT) in freeze-drying of parenteral products

Pharmaceutical Development and Technology, 2009
Quality 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
openaire   +2 more sources

Spectroscopy for Process Analytical Technology (PAT)

2010
Spectroscopic 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 Proceedings Volumes, 2005
Abstract 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   +2 more
openaire   +1 more source

Chemometrics in bioprocess engineering: process analytical technology (PAT) applications

Chemometrics and Intelligent Laboratory Systems, 2004
Abstract 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   +3 more
openaire   +1 more source

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