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, but none of them has been successfully applied. The objective of this work is to demonstrate the feasibility of an innovative concept to produce lyophilized unit-dose drugs using a continuous process. This novel strategy was demonstrated to improve both yield and vial-to-vial uniformity, giving all those advantages that are typical of continuous technology such as flexibility and elimination of process scale-up from laboratory to industrial scale.

Continuous freeze-drying and its relevance to the pharma/biotech industry / Pisano, Roberto; Capozzi, Luigi C.; Trout, Bernhardt. - ELETTRONICO. - (2017), pp. 1-26. ((Intervento presentato al convegno Integrated Continuous Biomanufacturing III tenutosi a Cascais (Portugal) nel September 17-21.

Continuous freeze-drying and its relevance to the pharma/biotech industry

Roberto Pisano;Luigi C. Capozzi;
2017

Abstract

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, but none of them has been successfully applied. The objective of this work is to demonstrate the feasibility of an innovative concept to produce lyophilized unit-dose drugs using a continuous process. This novel strategy was demonstrated to improve both yield and vial-to-vial uniformity, giving all those advantages that are typical of continuous technology such as flexibility and elimination of process scale-up from laboratory to industrial scale.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11583/2701006
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