Design space study of a chemical reaction with design of experiments

Authors

  • Pere Talavera Esteve Química. Departament d’R+D

Keywords:

Design of experiments (DoE), quality by design (QbD), critical quality attributes (CQAs), process acceptable ranges (PAR), design space, risk assessment.

Abstract

Quality by design applied to the development of chemical processes is an approach that is increasingly used in the pharmaceutical industry. This article describes its application in the optimization of a chemical reaction using design of experiments as a fundamental tool to achieve the goals of the study. In addition to optimizing the process, the robustness of the reaction must be ensured and all the knowledge of the process must be gathered to define and justify the design space. This information is assessed to support a regulatory submission.

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Author Biography

Pere Talavera, Esteve Química. Departament d’R+D

Pere Talavera és llicenciat en química i màster en química orgànica per la Universitat de Barcelona (UB) des de l’any 1999. Seguidament va gaudir d’una beca Universitat Empresa, UB-Laboratorios FYSE, i després va treballar per AstraZeneca Pharmaceuticals al Regne Unit, on assolí la posició de químic sènior. Des de l’any 2004 fins avui col·labora amb Esteve Química, a Barcelona, on actualment és responsable de suport a projectes.

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Issue

No. 20 (2021)

Section

Articles

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