Development and implementation of an advanced model predictive control system into continuous pharmaceutical tablet compaction process

Bhaskar, Aparajith; Barros, Fernando Nunes de; Singh, Ravendra

doi:10.1016/j.ijpharm.2017.10.003

Cited by 42 publications

(11 citation statements)

References 21 publications

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“…A growing interest has been seen towards the utilization of advanced process control (APC) strategies, such as model predictive control (MPC) and integrated feedforward control, both of which can be built upon the control structures described in the Levels 1-3 strategies. 141,142 A significant number of studies have focused on MPC of fermentation processes. 138,143,144 However, most work in this area is patented and this signifies the importance of applying MPC for continuous biomanufacturing.…”

Section: Design and Implementation Of The Control Systemmentioning

confidence: 99%

Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

Chopda

Gyorgypal

et al. 2021

J of Chemical Tech & Biotech

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Continuous bioprocessing is significantly changing the biological drugs (or biologics) manufacturing landscape by potentially improving product quality, process stability, and overall profitability, as was similarly seen during the adoption of advanced manufacturing processes for small molecule drugs in the past decade. However, the implementation of continuous manufacturing for biological processes producing protein-based drug molecules, such as monoclonal antibodies (mAbs), is facing several new hurdles. The barriers to continuous bioprocessing can be overcome through improved process understanding via better predictive capabilities enabled by hybrid modeling that can also lead to robust process control. This review article summarizes the recent advances and ongoing obstacles faced during the use of advanced process analytical technologies (PAT), process modeling, and control strategies to enable continuous manufacturing of mAbs. In addition, this review also discusses the process strategies and future directions of advanced continuous manufacturing approaches that have been adapted by other industries and that could be implemented for mAbs production soon.

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Section: Design and Implementation Of The Control Systemmentioning

confidence: 99%

Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

Chopda

Gyorgypal

et al. 2021

J of Chemical Tech & Biotech

Self Cite

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“…The overall system is comprised of products, equipment, people, information, control and support functions for the economic and competitive development, production, delivery and total lifecycle of products to satisfy market and societal needs.The Journal of Manufacturing Systems 42 Mechanistic ModelsA model described by first‐principles model equations and by well‐defined model parameters that have physical meaning. 43‐45 Model Predictive Control (MPC)Compensatory engineering control strategy that uses a dynamic model to create future trajectories of the process response based on measured process inputs and finite‐horizon optimization. MPC can simultaneously manipulate multiple variables to control various outputs. 15,46‐51 Overarching process control strategyPlanned set of control activities to assure process performance and quality, derived from current product and process understanding, that assures process performance and product quality. It includes raw material requirements, engineering controls, equipment, process step sequences etc.…”

Section: Term Engineering Definition Referencementioning

confidence: 99%

AIChE PD2M Advanced Process Control workshop‐moving APC forward in the pharmaceutical industry

Huang

O’Connor

Ahmed

et al. 2020

J Adv Manuf & Process

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This whitepaper summarizes the outcome of the first Advanced Process Control (APC) workshop in the pharmaceutical industry, presented by AIChE PD2M, and held in Washington DC, Sep 30 to Oct 01, 2019. Approximately 50 attendees from regulatory agencies, industry and academia had an opportunity to share perspectives and best practices on the business, technical and regulatory aspects of APC for both small and large molecule drug manufacturing. The event consisted of keynote talks, case studies and panel discussions, filled with lively interactions that focused on: (a) Business drivers for APC in pharma; (b) Alignment on the definitions of key terminology; (c) Clarification of roles and relationships of APC with regards to popular initiatives such as Quality by Design (QbD), Process Analytical Technology (PAT), Real Time Release testing (RTRt), Continued Process Verification (CPV), continuous manufacturing and digital manufacturing; (d) APC manufacturing implementation considerations; (e) Quality system and regulatory considerations for APC implementation; (f) APC opportunities in modular manufacturing, process intensification, integrated continuous manufacturing. (g) standards, training, and collaboration.

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“…If successfully implemented, this would be a revolution in pharmaceutical manufacturing and also for the Food and Drug Administration (FDA). Bhaskar [13] designed an advanced model predictive control (MPC) architecture integrated with a novel real-time tablet weight measurement method aimed to develop and implement continuous direct compacting tablet manufacturing pilot-plant which has the potential to control tablet weight and tablet breaking force simultaneously by systematically decoupling and cascading the control loops. The predictive control algorithm (PCA) was superior to the proportional, integral and derivative (PID) controller and consequently could be utilised for a wide range of applications to improve the quality of pharmaceutical products during continuous manufacturing.…”

Section: Quality Control During Bulk Pharmaceutical Productionmentioning

confidence: 99%

Quality Control Perspectives during Mass Production with a Focus on the Chemical Industry

Oduoza¹

2020

Mass Production Processes

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Mass production was part of the industrial revolution in 1870 and, with it, a huge step change in manufacturing processes. Its impact was ground breaking and became even more remarkable with automation in a business production environment. The chemical industry is one of the manufacturing sectors that has benefited from the technology of mass production achieved through automating the business process. In this era of industry 4.0 and with the associated advanced technologies of smart manufacturing, cloud computing, cyber physical systems and internet of things, mass production has been revolutionised but still faced issues such as quality control of the production process which was affected by supply chain management, customised production of commodity and specialty chemicals and huge demand from other chemical industry manufacturers. This chapter has reviewed the evolution of mass production during traditional manufacturing to the present day and carried out a risk assessment to quality of production in a mass production environment with a view to recommending adequate quality control of the production process. The chapter also included a case study for mass production of a pharmaceutical drug-Amoxicillin which was partly batch produced into dry powder and then mass produced using tableting and encapsulating machine, highlighting sources of contamination and inconsistency in tablet weight if adequate control measures were not put in place.

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Development and implementation of an advanced model predictive control system into continuous pharmaceutical tablet compaction process

Cited by 42 publications

References 21 publications

Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

AIChE PD2M Advanced Process Control workshop‐moving APC forward in the pharmaceutical industry

Quality Control Perspectives during Mass Production with a Focus on the Chemical Industry

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