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Working within the Design Space: Do Our Static Process Characterization Methods Suffice?

The Process Analytical Technology initiative and Quality by Design paradigm have led to changes in the guidelines and views of how to develop drug manufacturing processes. On this occasion the concept of the design space, which describes the impact of process parameters and material attributes on th...

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Autores principales: von Stosch, Moritz, Schenkendorf, René, Geldhof, Geoffroy, Varsakelis, Christos, Mariti, Marco, Dessoy, Sandrine, Vandercammen, Annick, Pysik, Alexander, Sanders, Matthew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356980/
https://www.ncbi.nlm.nih.gov/pubmed/32560435
http://dx.doi.org/10.3390/pharmaceutics12060562
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author von Stosch, Moritz
Schenkendorf, René
Geldhof, Geoffroy
Varsakelis, Christos
Mariti, Marco
Dessoy, Sandrine
Vandercammen, Annick
Pysik, Alexander
Sanders, Matthew
author_facet von Stosch, Moritz
Schenkendorf, René
Geldhof, Geoffroy
Varsakelis, Christos
Mariti, Marco
Dessoy, Sandrine
Vandercammen, Annick
Pysik, Alexander
Sanders, Matthew
author_sort von Stosch, Moritz
collection PubMed
description The Process Analytical Technology initiative and Quality by Design paradigm have led to changes in the guidelines and views of how to develop drug manufacturing processes. On this occasion the concept of the design space, which describes the impact of process parameters and material attributes on the attributes of the product, was introduced in the ICH Q8 guideline. The way the design space is defined and can be presented for regulatory approval seems to be left to the applicants, among who at least a consensus on how to characterize the design space seems to have evolved. The large majority of design spaces described in publications seem to follow a “static” statistical experimentation and modeling approach. Given that temporal deviations in the process parameters (i.e., moving within the design space) are of a dynamic nature, static approaches might not suffice for the consideration of the implications of variations in the values of the process parameters. In this paper, different forms of design space representations are discussed and the current consensus is challenged, which in turn, establishes the need for a dynamic representation and characterization of the design space. Subsequently, selected approaches for a dynamic representation, characterization and validation which are proposed in the literature are discussed, also showcasing the opportunity to integrate the activities of process characterization, process monitoring and process control strategy development.
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spelling pubmed-73569802020-07-23 Working within the Design Space: Do Our Static Process Characterization Methods Suffice? von Stosch, Moritz Schenkendorf, René Geldhof, Geoffroy Varsakelis, Christos Mariti, Marco Dessoy, Sandrine Vandercammen, Annick Pysik, Alexander Sanders, Matthew Pharmaceutics Perspective The Process Analytical Technology initiative and Quality by Design paradigm have led to changes in the guidelines and views of how to develop drug manufacturing processes. On this occasion the concept of the design space, which describes the impact of process parameters and material attributes on the attributes of the product, was introduced in the ICH Q8 guideline. The way the design space is defined and can be presented for regulatory approval seems to be left to the applicants, among who at least a consensus on how to characterize the design space seems to have evolved. The large majority of design spaces described in publications seem to follow a “static” statistical experimentation and modeling approach. Given that temporal deviations in the process parameters (i.e., moving within the design space) are of a dynamic nature, static approaches might not suffice for the consideration of the implications of variations in the values of the process parameters. In this paper, different forms of design space representations are discussed and the current consensus is challenged, which in turn, establishes the need for a dynamic representation and characterization of the design space. Subsequently, selected approaches for a dynamic representation, characterization and validation which are proposed in the literature are discussed, also showcasing the opportunity to integrate the activities of process characterization, process monitoring and process control strategy development. MDPI 2020-06-17 /pmc/articles/PMC7356980/ /pubmed/32560435 http://dx.doi.org/10.3390/pharmaceutics12060562 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Perspective
von Stosch, Moritz
Schenkendorf, René
Geldhof, Geoffroy
Varsakelis, Christos
Mariti, Marco
Dessoy, Sandrine
Vandercammen, Annick
Pysik, Alexander
Sanders, Matthew
Working within the Design Space: Do Our Static Process Characterization Methods Suffice?
title Working within the Design Space: Do Our Static Process Characterization Methods Suffice?
title_full Working within the Design Space: Do Our Static Process Characterization Methods Suffice?
title_fullStr Working within the Design Space: Do Our Static Process Characterization Methods Suffice?
title_full_unstemmed Working within the Design Space: Do Our Static Process Characterization Methods Suffice?
title_short Working within the Design Space: Do Our Static Process Characterization Methods Suffice?
title_sort working within the design space: do our static process characterization methods suffice?
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356980/
https://www.ncbi.nlm.nih.gov/pubmed/32560435
http://dx.doi.org/10.3390/pharmaceutics12060562
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