A practical method for resolving the nucleation problem in lyophilization

BioProcess International

Volumn 7, Issue 9, 2009, Pages 66-72

  Bursac, Ranko ^a   Sever, Robert ^a   Hunek, Balazs ^a  

^a PRAXAIR INC   (United States)

Author keywords

Freeze drying; Mannitol; Process control; QbD

Indexed keywords

DRUG ADDITIVE; EXCIPIENT; LACTATE DEHYDROGENASE; MANNITOL;

CRYSTALLIZATION; DRUG ACTIVITY; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG STABILITY; FREEZE DRYING; LIGHT SCATTERING; PHASE TRANSITION; PROTEIN AGGREGATION; PROTEIN DEGRADATION; QUALITY CONTROL; SHORT SURVEY;

EID: 77953368242     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (5)

1. Searles JA, Carpenter JF, Randolph TW. The Ice Nucleation Temperature Determines the Primary Drying Rate of Lyophilization for Samples Frozen on a Temperature-Controlled Shelf. J. Pharm. Sci. 90, 2001: 860-871.
2. Rambhatla S, et al. Heat and Mass Transfer Scale-Up Issues During Freeze Drying, II: Control and Characterization of the Degree of Super-Cooling. AAPS PharmSciTech 5, 2004: 1-9.
3. Rowe TD. A Technique for the Nucleation of Ice. International Symposium on Biological Product Freeze-Drying and Formulation, 26 October 1990, Geneva, Switzerland.
4. Nakagawa K, et al. Influence of Controlled Nucleation By Ultrasounds on Ice Morphology of Frozen Formulations for Pharmaceutical Proteins Freeze-Drying. Chem. Eng. Process 45, 2006: 783-791.
5. Petersen A, et al. A New Approach for Freezing Aqueous Solutions Under Active Control of the Nucleation Temperature. Cryobiol. 53, 2006: 248-257.