Lyophilization process design space.
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.
Department of Formulation Sciences, Biopharmaceutical Development, MedImmune, One MedImmune Way, Gaithersburg, Maryland, 20878.
Sajal Manubhai
SM
Patel
Michael J
MJ
Pikal
D005612:Freeze Drying / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods*
D004364:Pharmaceutical Preparations
Design Space; Scale-Up; freeze-drying/lyophilization; quality by design (QbD); heat and mass transfer; primary drying; process analytical technology (PAT); process validation; processing