Quality‐by‐Design (QbD): An Integrated Process Analytical Technology (PAT) Approach for Real‐Time Monitoring and Mapping the State of a Pharmaceutical Coprecipitation Process

2010 ◽  
Vol 99 (3) ◽  
pp. 1516-1534 ◽  
Author(s):  
Huiquan Wu ◽  
Mansoor A. Khan
Keyword(s):  
Real Time ◽  
Quality By Design ◽  
Process Analytical Technology ◽  
The State ◽  
Integrated Process ◽  
Real Time Monitoring ◽  
Coprecipitation Process ◽  
Analytical Technology

In situ real time monitoring of emulsification and homogenization processes for vaccine adjuvants

The Analyst ◽  
2022 ◽  
Author(s):  
Nicole M. Ralbovsky ◽  
Randal J. Soukup ◽  
Justin P. Lomont ◽  
Mackenzie L. Lauro ◽  
Amanda Gulasarian ◽  
...  
Keyword(s):  
Real Time ◽  
Process Analytical Technology ◽  
Vaccine Adjuvant ◽  
Formation Processes ◽  
Vaccine Adjuvants ◽  
Stable Emulsion ◽  
Real Time Monitoring ◽  
Analytical Technology

Process analytical technology was used to monitor formation of a stable emulsion product, with results providing improved understanding of emulsion-based vaccine adjuvant formation processes.

NIR spectroscopy as a process analytical technology (PAT) tool for on-line and real-time monitoring of an extraction process

2012 ◽  
Vol 58 ◽  
pp. 109-118 ◽  
Author(s):  
Yongjiang Wu ◽  
Ye Jin ◽  
Yerui Li ◽  
Di Sun ◽  
Xuesong Liu ◽  
...  
Keyword(s):  
Real Time ◽  
Process Analytical Technology ◽  
Nir Spectroscopy ◽  
Extraction Process ◽  
Real Time Monitoring ◽  
On Line ◽  
Analytical Technology

scholarly journals Advances in monitoring and control of refolding kinetics combining PAT and modeling

2021 ◽  
Vol 105 (6) ◽  
pp. 2243-2260
Author(s):  
Jan Niklas Pauk ◽  
Janani Raju Palanisamy ◽  
Julian Kager ◽  
Krisztina Koczka ◽  
Gerald Berghammer ◽  
...  
Keyword(s):  
Real Time ◽  
Quality By Design ◽  
Process Analytical Technology ◽  
Waste Product ◽  
High Yield ◽  
Monitoring And Control ◽  
Batch Mode ◽  
And Control ◽  
Analytical Technology ◽  
Refolding Kinetics

Abstract Overexpression of recombinant proteins in Escherichia coli results in misfolded and non-active protein aggregates in the cytoplasm, so-called inclusion bodies (IB). In recent years, a change in the mindset regarding IBs could be observed: IBs are no longer considered an unwanted waste product, but a valid alternative to produce a product with high yield, purity, and stability in short process times. However, solubilization of IBs and subsequent refolding is necessary to obtain a correctly folded and active product. This protein refolding process is a crucial downstream unit operation—commonly done as a dilution in batch or fed-batch mode. Drawbacks of the state-of-the-art include the following: the large volume of buffers and capacities of refolding tanks, issues with uniform mixing, challenging analytics at low protein concentrations, reaction kinetics in non-usable aggregates, and generally low re-folding yields. There is no generic platform procedure available and a lack of robust control strategies. The introduction of Quality by Design (QbD) is the method-of-choice to provide a controlled and reproducible refolding environment. However, reliable online monitoring techniques to describe the refolding kinetics in real-time are scarce. In our view, only monitoring and control of re-folding kinetics can ensure a productive, scalable, and versatile platform technology for re-folding processes. For this review, we screened the current literature for a combination of online process analytical technology (PAT) and modeling techniques to ensure a controlled refolding process. Based on our research, we propose an integrated approach based on the idea that all aspects that cannot be monitored directly are estimated via digital twins and used in real-time for process control. Key points • Monitoring and a thorough understanding of refolding kinetics are essential for model-based control of refolding processes. • The introduction of Quality by Design combining Process Analytical Technology and modeling ensures a robust platform for inclusion body refolding.

scholarly journals Process analytical technology (PAT) as a versatile tool for real-time monitoring and kinetic evaluation of photocatalytic reactions

2020 ◽  
Vol 5 (10) ◽  
pp. 1992-2002
Author(s):  
Martin Rößler ◽  
Philipp U. Huth ◽  
Marcel A. Liauw
Keyword(s):  
Raman Spectroscopy ◽  
Real Time ◽  
Multivariate Data Analysis ◽  
Process Analytical Technology ◽  
Real Time Monitoring ◽  
Kinetic Evaluation ◽  
Versatile Tool ◽  
Photocatalytic Reactions ◽  
Analytical Technology

Combining in situ Raman spectroscopy with multivariate data analysis enables the real-time monitoring and kinetic evaluation of photocatalytic reactions. The applicability is demonstrated on the photooxidation of 4-methoxythiophenol.

Real-Time Monitoring of Beer Parameters Using Infrared Spectroscopy—A Process Analytical Technology Approach

2020 ◽  
Vol 103 (6) ◽  
pp. 1654-1659
Author(s):  
Simone Tessarini Estevão ◽  
Felipe Rebello Lourenço
Keyword(s):  
Real Time ◽  
Process Analytical Technology ◽  
Partial Least Square ◽  
Least Square ◽  
Partial Least Square Regression ◽  
Real Time Monitoring ◽  
Alcohol Content ◽  
Barley Malt ◽  
Least Square Regression ◽  
Analytical Technology

Abstract Background Quality assessment of a finished beer product is usually performed by determining whether a sample from the batch conforms to the specifications and industry standards. However, if one or more quality parameters do not meet specifications, the batch must be reprocessed or even disposed of entirely. Objective The aim of this work was to propose real-time monitoring of beer parameters using infrared spectroscopy, according to the process analytical technology (PAT) approach. Method Sixteen formulations of beer containing barley malt, rice, maize, and/or oat malt were manufactured and analyzed, using an off-line infrared spectrometer and a beer analyzer, for alcohol content and density. All formulations were also subjected to color analysis, pH measurements, and sensory analysis. Results Partial least square regression models achieved coefficients of determination and prediction of 95.4% and 76.1% for the alcohol content, 90.9% and 69.2% for the density, 93.6% and 85.7% for the pH, and 98.1% and 94.8% for color, respectively. An infrared spectrometric method was used in the real-time monitoring of alcohol content, density, pH, and color of optimized (55% barley malt, 42% oat malt, and 3% maize) and standard (100% barley malt) formulations. Conclusions No statistical differences were observed between the results of the alcoholic content, density, pH, and color predicted by the partial least square regression and those obtained experimentally in the optimized and standard formulations. Highlights The application of the PAT tool is particularly useful for long manufacturing processes and can be applied in the development of food products.

On-line UV-NIR spectroscopy as a process analytical technology (PAT) tool for on-line and real-time monitoring of the extraction process of Coptis Rhizome

RSC Advances ◽  
2016 ◽  
Vol 6 (12) ◽  
pp. 10078-10085 ◽  
Author(s):  
Xuezhi Dai ◽  
Hang Song ◽  
Wen Liu ◽  
Shun Yao ◽  
Gang Wang
Keyword(s):  
Real Time ◽  
Process Analytical Technology ◽  
Nir Spectroscopy ◽  
Extraction Process ◽  
Real Time Monitoring ◽  
On Line ◽  
Analytical Technology

UV-NIR spectroscopy connected method as a tool for on-line and real-time monitoring of Coptis Rhizome extraction process.

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