Process Analytical Technology (PAT) and Quality by Design (QbD)

Dear Colleagues,

USFDA (United States Food and Drug Administration) guideline (Guidance to Industry Process Analytical Technology (PAT)) proposed a new paradigm for the manufacturing of pharmaceutical and biological products intended for human or animal use. The new paradigm requires that manufacturing processes be designed and controlled to assure that in-process materials and finished products meet predetermined quality requirements consistently and reliably.

Process Analytical Technology (PAT) is a system for design, analysis, and process control of manufacturing through timely measurement of critical quality and performance attributes of raw materials, in-process materials, and processes, with the goal of ensuring final product quality. Core contents are (1) Multivariate data acquisition and analysis tools; (2) Modern process analyzers or process analytical chemistry tools; (3) Process and endpoint monitoring and control tools; and (4) Continuous improvement and knowledge management tools.

The Quality by Design (QbD) framework concerns designing and developing processes that can consistently ensure a predefined quality, resulting in real-time release of products. Implementing the QbD paradigm requires a thorough understanding of the relationship between the critical quality attributes (CQAs) and the clinical properties of the product, the relationship between the process and CQAs, and the variability in raw materials.

Thus far, the concepts and associated flexibility expected from the new initiative implementation have now been fully realized. Some manufacturers are still facing challenges due to variations from raw material ingredients, lack of appropriate measurements of intermediate parameters, and even inappropriate analytical methods of final product quality attributes. All these factors force pharmaceutical developers and manufacturers to maintain tight control over operating conditions yet provide less robust control of safety and efficacy.

The Special Issue, “Process Analytical Technology (PAT) and Quality by Design (QbD)” of the journal Processes, aims to cover recent advances in PAT and QbD. Appropriate contributions include novel sensing technology, new process control and optimization in therapeutics development and production, advanced process monitoring and characterization, real-time batch release, advances in integrated and continuous bio/pharmaceutical processes, bigdata analytics, systems/syntheric biology, applications and solution strategies in PAT/QbD are also welcomed.

Dr. Seongkyu Yoon
Guest Editor

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• Raw material characterization
• Advances in sensing technology
• Process monitoring and control
• Advances in Quality by Design implementation
• Bigdata analytics
• Systems and synthetic biology in bio/pharmaceutical area
• Application in therapeutic development and production
• Realtime Process Release
• Continuous process validation
• Continuous bio/pharmaceutical manufacturing
• Methodology in biosimilar comparability