scholarly journals Process Analytical Technology for Advanced Process Control in Biologics Manufacturing with the Aid of Macroscopic Kinetic Modeling

2018 ◽  
Vol 5 (1) ◽  
pp. 25 ◽  
Author(s):  
Martin Kornecki ◽  
Jochen Strube
Keyword(s):  
Process Control ◽  
Kinetic Modeling ◽  
Process Analytical Technology ◽  
Advanced Process Control ◽  
Analytical Technology

scholarly journals Towards Autonomous Operation by Advanced Process Control—Process Analytical Technology for Continuous Biologics Antibody Manufacturing

Processes ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 172
Author(s):  
Heribert Helgers ◽  
Axel Schmidt ◽  
Lara Julia Lohmann ◽  
Florian Lukas Vetter ◽  
Alex Juckers ◽  
...  
Keyword(s):  
Process Control ◽  
Product Quality ◽  
Process Development ◽  
Process Analytical Technology ◽  
Control Process ◽  
Continuous Manufacturing ◽  
Two Phase ◽  
Advanced Process Control ◽  
Vis Spectroscopy ◽  
Analytical Technology

Continuous manufacturing opens up new operation windows with improved product quality in contrast to documented lot deviations in batch or fed-batch operations. A more sophisticated process control strategy is needed to adjust operation parameters and keep product quality constant during long-term operations. In the present study, the applicability of a combination of spectroscopic methods was evaluated to enable Advanced Process Control (APC) in continuous manufacturing by Process Analytical Technology (PAT). In upstream processing (USP) and aqueous two-phase extraction (ATPE), Raman-, Fourier-transformed infrared (FTIR), fluorescence- and ultraviolet/visible- (UV/Vis) spectroscopy have been successfully applied for titer and purity prediction. Raman spectroscopy was the most versatile and robust method in USP, ATPE, and precipitation and is therefore recommended as primary PAT. In later process stages, the combination of UV/Vis and fluorescence spectroscopy was able to overcome difficulties in titer and purity prediction induced by overlapping side component spectra. Based on the developed spectroscopic predictions, dynamic control of unit operations was demonstrated in sophisticated simulation studies. A PAT development workflow for holistic process development was proposed.

scholarly journals Multi-angle light scattering as a process analytical technology measuring real-time molecular weight for downstream process control

mAbs ◽  
2018 ◽  
pp. 1-6
Author(s):  
Bhumit A. Patel ◽  
Adrian Gospodarek ◽  
Michael Larkin ◽  
Sophia A. Kenrick ◽  
Mark A. Haverick ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Light Scattering ◽  
Process Control ◽  
Real Time ◽  
Process Analytical Technology ◽  
Downstream Process ◽  
Analytical Technology

scholarly journals Process Analytical Technology for Precipitation Process Integration into Biologics Manufacturing towards Autonomous Operation—mAb Case Study

Processes ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 488
Author(s):  
Lara Julia Lohmann ◽  
Jochen Strube
Keyword(s):  
Process Control ◽  
Real Time ◽  
Process Analytical Technology ◽  
Measurement Techniques ◽  
Array Detector ◽  
Precipitation Process ◽  
Suitable Model ◽  
Process Data ◽  
Autonomous Operation ◽  
Analytical Technology

The integration of real time release testing into an advanced process control (APC) concept in combination with digital twins accelerates the process towards autonomous operation. In order to implement this, on the one hand, measurement technology is required that is capable of measuring relevant process data online, and on the other hand, a suitable model must be available to calculate new process parameters from this data, which are then used for process control. Therefore, the feasibility of online measurement techniques including Raman-spectroscopy, attenuated total reflection Fourier transformed infrared spectroscopy (ATR-FTIR), diode array detector (DAD) and fluorescence is demonstrated within the framework of the process analytical technology (PAT) initiative. The best result is achieved by Raman, which reliably detected mAb concentration (R2 of 0.93) and purity (R2 of 0.85) in real time, followed by DAD. Furthermore, the combination of DAD and Raman has been investigated, which provides a promising extension due to the orthogonal measurement methods and higher process robustness. The combination led to a prediction for concentration with a R2 of 0.90 ± 3.9% and for purity of 0.72 ± 4.9%. These data are used to run simulation studies to show the feasibility of process control with a suitable digital twin within the APC concept.

scholarly journals Advancement of process control using process analytical technology (PAT) in continuous biomanufacturing: Case study

2020 ◽  
Author(s):  
Sobhana Alekhya Sripada ◽  
Sushmitha Krishnan ◽  
Rajan Bhawnani ◽  
Jessica Molek ◽  
Aparajith Bhaskar ◽  
...  
Keyword(s):  
Process Control ◽  
Process Analytical Technology ◽  
Analytical Technology

scholarly journals Advancement of process control using process analytical technology (PAT) in continuous biomanufacturing: Case study

2020 ◽  
Author(s):  
Sobhana Alekhya Sripada ◽  
Sushmitha Krishnan ◽  
Rajan Bhawnani ◽  
Jessica Molek ◽  
Aparajith Bhaskar ◽  
...  
Keyword(s):  
Process Control ◽  
Process Analytical Technology ◽  
Analytical Technology

scholarly journals Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

2020 ◽  
Vol 70 (4) ◽  
pp. 443-463 ◽  
Author(s):  
Aleša Dular Vovko ◽  
Franc Vrečer
Keyword(s):  
Infrared Spectroscopy ◽  
Process Control ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Process Analytical Technology ◽  
Imaging Techniques ◽  
Thermal Effusivity ◽  
Chemical Imaging ◽  
Roller Compaction ◽  
Analytical Technology

AbstractThis article presents an overview of using process analytical technology in monitoring the roller compaction process. In the past two decades, near-infrared spectroscopy, near-infrared spectroscopy coupled with chemical imaging, microwave resonance technology, thermal effusivity and various particle imaging techniques have been used for developing at-, off-, on- and in-line models for predicting critical quality attributes of ribbons and subsequent granules and tablets. The common goal of all these methods is improved process understanding and process control, and thus improved production of high-quality products. This article reviews the work of several researchers in this field, comparing and critically evaluating their achievements.

scholarly journals Digital Twin for Extraction Process Design and Operation

Processes ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. 866 ◽  
Author(s):  
Lukas Uhlenbrock ◽  
Christoph Jensch ◽  
Martin Tegtmeier ◽  
Jochen Strube
Keyword(s):  
Process Analytical Technology ◽  
Extraction Process ◽  
Process Models ◽  
Advanced Process Control ◽  
Manufacturing Optimization ◽  
Innovative Methods ◽  
Digital Twins ◽  
Extraction Processes ◽  
Regulated Industries ◽  
Analytical Technology

Traditional extraction processes of natural product are widespread, especially in regulated industries. Possibilities of extraction development and manufacturing optimization in regulated industries is limited. Regulatory approvals are often based on traditional preparations of phyto-pharmaceuticals. The dependence on traditional processes can result in sub-optimal extraction parameters causing unnecessary costs and product variability. Innovative methods like Quality-by-Design (QbD), including process analytical technology (PAT), open opportunities for manufacturers to cope with regulatory demanded, narrow batch-to-batch variability. In addition, such validated process models represent perfect digital twins which could be utilized for advanced process control and life cycle analysis.

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