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Perspective

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

1
GSK, B-1330 Rixensart, Belgium
2
Institute of Energy and Process Systems Engineering, TU Braunschweig, 38106 Braunschweig, Germany
3
Center of Pharmaceutical Engineering, TU Braunschweig, 38106 Braunschweig, Germany
*
Author to whom correspondence should be addressed.
Current address: DataHow AG, Zurich, Switzerland.
Pharmaceutics 2020, 12(6), 562; https://doi.org/10.3390/pharmaceutics12060562
Received: 25 May 2020 / Revised: 10 June 2020 / Accepted: 11 June 2020 / Published: 17 June 2020
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. View Full-Text
Keywords: process analytical technology; quality by design; dynamic design space; reachability; flexibility; dynamic modeling; critical process parameters; critical quality attribute process analytical technology; quality by design; dynamic design space; reachability; flexibility; dynamic modeling; critical process parameters; critical quality attribute
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MDPI and ACS Style

von Stosch, M.; Schenkendorf, R.; Geldhof, G.; Varsakelis, C.; Mariti, M.; Dessoy, S.; Vandercammen, A.; Pysik, A.; Sanders, M. Working within the Design Space: Do Our Static Process Characterization Methods Suffice? Pharmaceutics 2020, 12, 562. https://doi.org/10.3390/pharmaceutics12060562

AMA Style

von Stosch M, Schenkendorf R, Geldhof G, Varsakelis C, Mariti M, Dessoy S, Vandercammen A, Pysik A, Sanders M. Working within the Design Space: Do Our Static Process Characterization Methods Suffice? Pharmaceutics. 2020; 12(6):562. https://doi.org/10.3390/pharmaceutics12060562

Chicago/Turabian Style

von Stosch, Moritz, René Schenkendorf, Geoffroy Geldhof, Christos Varsakelis, Marco Mariti, Sandrine Dessoy, Annick Vandercammen, Alexander Pysik, and Matthew Sanders. 2020. "Working within the Design Space: Do Our Static Process Characterization Methods Suffice?" Pharmaceutics 12, no. 6: 562. https://doi.org/10.3390/pharmaceutics12060562

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