Lyophilization process design space

Journal of Pharmaceutical Sciences

Volumn 102, Issue 11, 2013, Pages 3883-3887

  Patel, Sajal Manubhai ^a   Pikal, Michael J ^b  

^a MEDIMMUNE   (United States)

^b UNIVERSITY OF CONNECTICUT   (United States)

Author keywords

Design Space; Freeze drying lyophilization; quality by design (QbD); Heat and mass transfer; Primary drying; Process analytical technology (PAT); Process validation; Processing; Scale Up

Indexed keywords

DRUG FORMULATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG STABILITY; FREEZE DRYING; NOTE; PROCESS DESIGN; TEMPERATURE DEPENDENCE;

DESIGN SPACE; FREEZE-DRYING/LYOPHILIZATION; QUALITY BY DESIGN (QBD); HEAT AND MASS TRANSFER; PRIMARY DRYING; PROCESS ANALYTICAL TECHNOLOGY (PAT); PROCESS VALIDATION; PROCESSING; SCALE-UP;

FREEZE DRYING; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL;

EID: 84885835306     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23703     Document Type: Note

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