Active Process Control in Pharmaceutical Continuous Manufacturing – The Quality by Control (QbC) Paradigm

Pharmaceutical continuous manufacturing is essentially in a steady state, or in a state of control, in process operation, by which variations in critical material/product properties and process parameters can be monitored and controlled in real time within an acceptable range that enables the comprehensive implementation of the Quality by Design (QbD) principles. This advantage, facilitated by the implementation of active process control, has recently been evolving and nurturing a new paradigm of Quality by Control (QbC) in pharmaceutical continuous manufacturing. The concept of QbC has acquired acknowledgement in recent applications in pharmaceutical continuous manufacturing and bioprocessing.

[1]  Chris Potter,et al.  PQLI Application of Science- and Risk-based Approaches (ICH Q8, Q9, and Q10) to Existing Products , 2009, Journal of Pharmaceutical Innovation.

[2]  Jose A. Romagnoli,et al.  Data Reconciliation - an Industrial Case Study , 1993 .

[3]  Shantenu Jha,et al.  A Systematic Framework for Data Management and Integration in a Continuous Pharmaceutical Manufacturing Processing Line , 2018 .

[4]  Zoltan K. Nagy,et al.  ON–OFF Feedback Control of Plug-Flow Crystallization: A Case of Quality-by-Control in Continuous Manufacturing , 2017, IEEE Life Sciences Letters.

[5]  Marianthi Ierapetritou,et al.  Integrated Moving Horizon-Based Dynamic Real-Time Optimization and Hybrid MPC-PID Control of a Direct Compaction Continuous Tablet Manufacturing Process , 2015, Journal of Pharmaceutical Innovation.

[6]  M. Bagajewicz,et al.  Data Reconciliation in Gas Pipeline Systems , 2003 .

[7]  G. Reklaitis,et al.  Perspectives on the continuous manufacturing of powder‐based pharmaceutical processes , 2016 .

[8]  Richard D. Braatz,et al.  Model‐based design of a plant‐wide control strategy for a continuous pharmaceutical plant , 2013 .

[9]  Weidong Yang,et al.  Detection of model-plant mismatch in closed-loop control system , 2017 .

[10]  Zoltan K. Nagy,et al.  Dynamic impact milling model with a particle-scale breakage kernel , 2016 .

[11]  Brahim Benyahia,et al.  A Plant-Wide Dynamic Model of a Continuous Pharmaceutical Process , 2012 .

[12]  Gintaras V. Reklaitis,et al.  Variation and Risk Analysis in Tablet Press Control for Continuous Manufacturing of Solid Dosage via Direct Compaction. , 2018, International symposium on process systems engineering.

[13]  Rohit Ramachandran,et al.  Model-Based Control-Loop Performance of a Continuous Direct Compaction Process , 2011, Journal of Pharmaceutical Innovation.

[14]  Ravendra Singh.  Automation of continuous pharmaceutical manufacturing process , 2018 .

[15]  Manfred Morari,et al.  Performance monitoring of control systems using likelihood methods , 1996, Autom..

[16]  Biao Huang,et al.  Data quality assessment of routine operating data for process identification , 2013, Comput. Chem. Eng..

[17]  Zoltan K. Nagy,et al.  Mathematical modelling and experimental validation of a novel periodic flow crystallization using MSMPR crystallizers , 2017 .

[18]  José Carlos Pinto,et al.  Performance Evaluation of Real Industrial RTO Systems , 2016 .

[19]  Gintaras V. Reklaitis,et al.  Modeling and Control of Roller Compaction for Pharmaceutical Manufacturing , 2010, Journal of Pharmaceutical Innovation.

[20]  Marianthi G. Ierapetritou,et al.  Modeling of Particulate Processes for the Continuous Manufacture of Solid-Based Pharmaceutical Dosage Forms , 2013 .

[21]  Joseph Moses Juran.  Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services , 1992 .

[22]  Dimitrios I. Gerogiorgis,et al.  Process modelling, simulation and technoeconomic evaluation of crystallisation antisolvents for the continuous pharmaceutical manufacturing of rufinamide , 2018, Comput. Chem. Eng..

[23]  K. Plumb,et al.  Continuous Processing in the Pharmaceutical Industry: Changing the Mind Set , 2005 .

[24]  Qinglin Su,et al.  A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing , 2019, Comput. Chem. Eng..

[25]  H Leuenberger,et al.  New trends in the production of pharmaceutical granules: batch versus continuous processing. , 2001, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[26]  Diego Martinez Prata,et al.  Simultaneous robust data reconciliation and gross error detection through particle swarm optimization for an industrial polypropylene reactor , 2010 .

[27]  Biao Huang,et al.  Minimal required excitation for closed-loop identification: Some implications for data-driven, system identification☆ , 2015 .

[28]  Yang Yang,et al.  Advanced control approaches for combined cooling/antisolvent crystallization in continuous mixed suspension mixed product removal cascade crystallizers , 2015 .

[29]  Aditya U. Vanarase,et al.  Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy , 2010 .

[30]  Sudarshan Ganesh,et al.  Application of X-Ray Sensors for In-line and Noninvasive Monitoring of Mass Flow Rate in Continuous Tablet Manufacturing. , 2017, Journal of pharmaceutical sciences.

[31]  Sirish L. Shah,et al.  Closed-loop model validation based on the two-model divergence method , 2007, IEEE Conference on Decision and Control.

[32]  Ravendra Singh.  Model-based control system design and evaluation for continuous tablet manufacturing processes (via direct compaction, via roller compaction, via wet granulation) , 2018 .

[33]  Richard D. Braatz,et al.  The Application of an Automated Control Strategy for an Integrated Continuous Pharmaceutical Pilot Plant , 2015 .

[34]  Jin Jiang,et al.  Fault-tolerant control systems: A comparative study between active and passive approaches , 2012, Annu. Rev. Control..

[35]  Fernando J. Muzzio,et al.  A Combined Feed-Forward/Feed-Back Control System for a QbD-Based Continuous Tablet Manufacturing Process , 2015 .

[36]  Guy A. Dumont,et al.  Control system performance monitoring: New developments and practical issues , 2002 .

[37]  Marianthi G. Ierapetritou,et al.  A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process , 2014, Comput. Chem. Eng..

[38]  Gintaras V. Reklaitis,et al.  Intelligent Alarm Management Applied to Continuous Pharmaceutical Tablet Manufacturing: An Integrated Approach , 2013 .

[39]  Krist V. Gernaey,et al.  Systematic substrate adoption methodology (SAM) for future flexible, generic pharmaceutical production processes , 2013, Comput. Chem. Eng..

[40]  Biao Huang,et al.  Closed-loop identification with routine operating data: Effect of time delay and sampling time ☆ , 2011 .

[41]  Richard D. Braatz,et al.  Just-in-Time-Learning based Extended Prediction Self-Adaptive Control for batch processes , 2016 .

[42]  Gintaras V. Reklaitis,et al.  A Systematic Framework for Process Control Design and Risk Analysis in Continuous Pharmaceutical Solid-Dosage Manufacturing , 2017, Journal of Pharmaceutical Innovation.

[43]  Allan S. Myerson,et al.  Continuous Crystallization and Polymorph Dynamics in the l-Glutamic Acid System , 2014 .

[44]  M. Chiu,et al.  Monitoring pH-Shift Reactive Crystallization of L-Glutamic Acid Using Moving Window MPCA , 2016 .

[45]  Marianthi Ierapetritou,et al.  An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction. , 2012, International journal of pharmaceutics.

[46]  Benoît Igne,et al.  Modeling strategies for pharmaceutical blend monitoring and end-point determination by near-infrared spectroscopy. , 2014, International journal of pharmaceutics.

[47]  Qiang Ye,et al.  Research on data reconciliation based on generalized T distribution with historical data , 2016, Neurocomputing.

[48]  John J. Peterson,et al.  Batch-to-Batch Variation: A Key Component for Modeling Chemical Manufacturing Processes , 2015 .

[49]  Ahmad Rafiee,et al.  Data reconciliation with application to a natural gas processing plant , 2016 .

[50]  Gintaras V. Reklaitis,et al.  Modeling and Control of Roller Compaction for Pharmaceutical Manufacturing. Part I: Process Dynamics and Control Framework , 2010, Journal of Pharmaceutical Innovation.

[51]  Sigurd Buchholz,et al.  Future manufacturing approaches in the chemical and pharmaceutical industry , 2010 .

[52]  Yang Yang,et al.  Combined Cooling and Antisolvent Crystallization in Continuous Mixed Suspension, Mixed Product Removal Cascade Crystallizers: Steady-State and Startup Optimization , 2015 .

[53]  R. Braatz,et al.  JITL-based concentration control for semi-batch pH-shift reactive crystallization of l-glutamic acid , 2014 .

[54]  J. Dennis,et al.  Techniques for nonlinear least squares and robust regression , 1978 .

[55]  Ravendra Singh.  Implementation of control system into continuous pharmaceutical manufacturing pilot plant (powder to tablet) , 2018 .

[56]  Mogens Blanke,et al.  Fault-tolerant control systems — A holistic view , 1997 .

[57]  José Carlos Pinto,et al.  Numerical Aspects of Data Reconciliation in Industrial Applications , 2017 .

[58]  Zoltan K. Nagy,et al.  Pharmaceutical crystallisation processes from batch to continuous operation using MSMPR stages: Modelling, design, and control , 2015 .

[59]  Lakshman Pernenkil,et al.  Continuous blending of dry pharmaceutical powders , 2008 .

[60]  Buket Aksu,et al.  Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT). , 2012, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[61]  Gintaras V. Reklaitis,et al.  Data reconciliation in the Quality‐by‐Design (QbD) implementation of pharmaceutical continuous tablet manufacturing , 2019, International journal of pharmaceutics.

[62]  P. Hubert,et al.  Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process. , 2014, Journal of pharmaceutical and biomedical analysis.

[63]  Lawrence X. Yu,et al.  Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production , 2015, Journal of Pharmaceutical Innovation.

[64]  Krist V. Gernaey,et al.  Model-based computer-aided framework for design of process monitoring and analysis systems , 2009, Comput. Chem. Eng..

[65]  Gintaras V. Reklaitis,et al.  Robust state estimation of feeding-blending systems in continuous pharmaceutical manufacturing. , 2018, Chemical engineering research & design : transactions of the Institution of Chemical Engineers.

[66]  G. K. Raju,et al.  Understanding Pharmaceutical Quality by Design , 2014, The AAPS Journal.

[67]  John F. MacGregor,et al.  Multi-way partial least squares in monitoring batch processes , 1995 .