The application of key elements of quality by design (QbD), such as risk assessment, process analytical technology, and design space, is discussed widely as it relates to freeze-drying process design and development. However, this commentary focuses on constructing the Design and Control Space, particularly for the primary drying step of the freeze-drying process. Also, practical applications and considerations of claiming a process Design Space under the QbD paradigm have been discussed.
Keywords: Design Space; Scale-Up; freeze-drying/lyophilization; quality by design (QbD); heat and mass transfer; primary drying; process analytical technology (PAT); process validation; processing.
© 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.