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

Moritz von Stosch1, René Schenkendorf2,3, Geoffroy Geldhof1

  • 1GSK, B-1330 Rixensart, Belgium.

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|June 21, 2020
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Summary
This summary is machine-generated.

Current drug development guidelines, like Quality by Design, introduce the design space concept. However, static approaches to characterizing the design space may not fully capture dynamic process variations, necessitating dynamic representations.

Keywords:
critical process parameterscritical quality attributedynamic design spacedynamic modelingflexibilityprocess analytical technologyquality by designreachability

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Process Analytical Technology

Background:

  • The Quality by Design paradigm and Process Analytical Technology initiative have reshaped drug manufacturing process development.
  • ICH Q8 guideline introduced the design space, defining the impact of process parameters and material attributes on product attributes.

Purpose of the Study:

  • To discuss various design space representations.
  • To challenge the current consensus on static design space characterization.
  • To establish the need for dynamic design space representation and characterization.

Main Methods:

  • Review and discussion of different design space representation forms.
  • Analysis of static statistical experimentation and modeling approaches.
  • Exploration of literature-proposed dynamic representation, characterization, and validation approaches.

Main Results:

  • A consensus on characterizing the design space appears to have evolved among applicants.
  • The majority of published design spaces utilize static statistical and modeling approaches.
  • Static approaches may be insufficient for dynamic process parameter variations within the design space.

Conclusions:

  • The dynamic nature of temporal process parameter deviations necessitates dynamic design space characterization.
  • Dynamic representations offer opportunities to integrate process characterization, monitoring, and control strategies.
  • Further research into dynamic design space methodologies is required for robust drug manufacturing.