Workshop 1: New Directions in Pharmaceutical Process Development and Manufacturing: Process Analytical Technology (PAT), Quality by Design (QbD), Design Space (DS), and other FDA Initiatives

2011 ◽  
pp. 731-733
Author(s):  
Sadettin S. Ozturk ◽  
Nigel Jenkins
Keyword(s):  
Manufacturing Process ◽  
Quality By Design ◽  
Design Space ◽  
Process Development ◽  
Process Analytical Technology ◽  
New Directions ◽  
Analytical Technology

scholarly journals Advanced Process Analytical Technology in Combination with Process Modeling for Endpoint and Model Parameter Determination in Lyophilization Process Design and Optimization

Processes ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1600
Author(s):  
Alex Juckers ◽  
Petra Knerr ◽  
Frank Harms ◽  
Jochen Strube
Keyword(s):  
Process Design ◽  
Quality By Design ◽  
Process Development ◽  
Process Analytical Technology ◽  
Parameter Determination ◽  
Design And Optimization ◽  
Manometric Temperature Measurement ◽  
Analytical Technology ◽  
Main Shortcoming

Lyophilization is widely used in the preservation of thermolabile products. The main shortcoming is the long processing time. Lyophilization processes are mostly based on a recipe that is not changed, but, with the Quality by Design (QbD) approach and use of Process Analytical Technology (PAT), the process duration can be optimized for maximum productivity while ensuring product safety. In this work, an advanced PAT approach is used for the endpoint determination of primary drying. Manometric temperature measurement (MTM) and comparative pressure measurement are used to determine the endpoint of the batch while a modeling approach is outlined that is able to calculate the endpoint of every vial in the batch. This approach can be used for process development, control and optimization.

A Process Analytical Technology (PAT) approach to control a new API manufacturing process: Development, validation and implementation

Talanta ◽  
2014 ◽  
Vol 120 ◽  
pp. 114-125 ◽  
Author(s):  
Cédric Schaefer ◽  
David Clicq ◽  
Clémence Lecomte ◽  
Alain Merschaert ◽  
Edith Norrant ◽  
...  
Keyword(s):  
Manufacturing Process ◽  
Process Development ◽  
Process Analytical Technology ◽  
Analytical Technology

Process Analytical Technology and Quality by Design for Animal Cell Culture

2019 ◽  
pp. 365-390
Author(s):  
Hae‐Woo Lee ◽  
Hemlata Bhatia ◽  
Seo‐Young Park ◽  
Mark‐Henry Kamga ◽  
Thomas Reimonn ◽  
...  
Keyword(s):  
Cell Culture ◽  
Quality By Design ◽  
Process Analytical Technology ◽  
Animal Cell ◽  
Animal Cell Culture ◽  
Analytical Technology

Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT)

2016 ◽  
Vol 90 ◽  
pp. 2-7 ◽  
Author(s):  
Marcel de Matas ◽  
Thomas De Beer ◽  
Staffan Folestad ◽  
Jarkko Ketolainen ◽  
Hans Lindén ◽  
...  
Keyword(s):  
Quality By Design ◽  
Process Analytical Technology ◽  
Education And Training ◽  
Strategic Framework ◽  
Analytical Technology ◽  
And Training
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