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Full-Text Articles in Engineering
Continuous Manufacturing - Ema Perspective And Experience, Nino Mihokovic
Continuous Manufacturing - Ema Perspective And Experience, Nino Mihokovic
Integrated Continuous Biomanufacturing III
Continuous manufacturing provides a distinct set of advantages and challenges from technical and regulatory viewpoints. Challenges such as batch definition and traceability, dynamic control strategies, use of Process Analytical Technologies, validation strategies and specifications are some of the areas which can require new perspectives from both industry and regulators. This presentation will reflect on the current regulatory environment and principles applied to continuous manufacturing; it aims to share the European experience with marketing authorisation applications using aspects of continuous manufacturing; and outlines Agency support to innovation and opportunities to consult and interact with the regulatory authorities during various stages of …
Continuous Freeze-Drying And Its Relevance To The Pharma/Biotech Industry, Roberto Pisano, Luigi C. Capozzi, Bernhardt Trout
Continuous Freeze-Drying And Its Relevance To The Pharma/Biotech Industry, Roberto Pisano, Luigi C. Capozzi, Bernhardt Trout
Integrated Continuous Biomanufacturing III
The new paradigm of pharmaceutical industry is to move from batch to continuous processes in order to satisfy the stringent requirements of quality, safety and efficiency set by regulatory authorities and reduce production costs. In this perspective, freeze-drying needs to be completely rethought in order to be more integrated in the chain of production of drugs, more flexible to respond to variations in market needs and allowing the monitoring of product quality. The future of freeze-drying, as a downstream process, is therefore to move from batch to continuous. Over the past decades many ideas regarding continuous freeze-drying has been proposed, …