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From production to bedside: A tiered QC framework for regulatory alignment and analytical comparability in decentralized CGT. [PDF]
Regen TherNahum S +6 more
europepmc +1 more source
RSM-Optimized Ultrasonic-Assisted Extraction for High-Efficiency Recovery of Pb, Cd, and As in Complex Systems. [PDF]
ACS OmegaKlinpratoom B +11 more
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Applications of process analytical technology to crystallization processes
Advanced Drug Delivery Reviews, 2004Crystallizations of pharmaceutical active ingredients, particularly those that posses multiple polymorphic forms, are among the most critical and least understood pharmaceutical manufacturing processes. Many process and product failures can be traced to a poor understanding and control of crystallization processes.
Robert Lionberger +2 more
exaly +3 more sources
2005
Process analytical technology , Process analytical technology , کتابخانه مرکزی دانشگاه علوم پزشکی ...
Ajaz Hussain, D Christopher Watts
+4 more sources
Process analytical technology , Process analytical technology , کتابخانه مرکزی دانشگاه علوم پزشکی ...
Ajaz Hussain, D Christopher Watts
+4 more sources
2013
The term “process analytical technology” (PAT) has been used to describe the application of analytical chemistry and process chemistry combined with the multivariate tools for process understanding. PAT is a wide and complex theme, making it difficult to capture all the features in this chapter.
Teixeira, J. A. +4 more
openaire +3 more sources
The term “process analytical technology” (PAT) has been used to describe the application of analytical chemistry and process chemistry combined with the multivariate tools for process understanding. PAT is a wide and complex theme, making it difficult to capture all the features in this chapter.
Teixeira, J. A. +4 more
openaire +3 more sources
Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients [PDF]
Current Pharmaceutical Design, 2018 Background: Pharmaceutical industry is witnessing increased pressure to introduce innovative and efficient processes for manufacturing Active Pharmaceutical Ingredients (APIs) in order to be competitive as well as to meet the stringent product quality requirements set by regulatory authorities.
Haiyan Qu +1 more
exaly +4 more sources
In an ideally regulated manufacturing industry, when a process is launched, its progress should be easily monitored and controlled until that process is completed. This means that at any given time, the condition and the quality of the product with respect to yield are transparent and known.
Alok Kumar Srivastav, Priyanka Das
exaly +3 more sources
Systematic assessment of process analytical technologies for biologics
Biotechnology and Bioengineering, 2021AbstractThe application of process analytical technology (PAT) for biotherapeutic development and manufacturing has been employed owing to technological, economic, and regulatory advantages across the industry. Typically, chromatographic, spectroscopic, and/or mass spectrometric sensors are integrated into upstream and downstream unit operations in in ...
Christopher Gillespie +6 more
openaire +2 more sources