A Framework for Efficient Process Development Using Optimal Experimental Designs

Peter van de Ven, Sabina Bijlsma, Erik Gout, Kees van der Voort Maarschalk, Uwe Thissen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)

Abstract

Introduction The aim of this study was to develop and demonstrate a framework assuring efficient process development using fewer experiments than standard experimental designs.

Methods A novel optimality criterion for experimental designs (Iw criterion) is defined that leads to more efficient process development because: (a) prior knowledge is used in the experimental design to focus on optimal processing conditions and (b) a lean design is used which can dramatically reduce the number of experiments compared to standard designs. In this way, the criterion serves as a framework to connect a series of screening and optimization designs.

Results The philosophy behind the Iw criterion is explained including a detailed step-wise discussion how to apply it in practice. Moreover, its advantages were shown in an industrial process development case using a screening and an optimization design that were not explicitly connected. In this paper, a reduction of 21% of experiments could be obtained compared to the traditional approach using standard experimental designs and no framework.

Conclusions The Iw criterion is a valuable tool to increase accuracy and to speed up research that contain sets of experiments and where prior knowledge is already available or will be derived using screening designs.

Original languageEnglish
Pages (from-to)24-31
Number of pages8
JournalJournal of pharmaceutical innovation
Volume6
Issue number1
DOIs
Publication statusPublished - Apr-2011

Keywords

  • Design of experiments (DOE)
  • Optimal design
  • I optimal
  • Quality by design
  • Process development

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