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

• Main Authors: Moritz von Stosch (Author), René Schenkendorf (Author), Geoffroy Geldhof (Author), Christos Varsakelis (Author), Marco Mariti (Author), Sandrine Dessoy (Author), Annick Vandercammen (Author), Alexander Pysik (Author), Matthew Sanders (Author)
• Format: Book
• Published: MDPI AG, 2020-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...