Large-scale freezing of biologics: Understanding protein and solute concentration changes in a cryovessel - Part I

BioPharm International

Volumn 23, Issue 6, 2010, Pages 53-60

  Kolhe, Parag ^a   Holding, Elisabeth ^a   Lary, Alanta ^a   Chico, Steven ^a   Singh, Satish K ^b  

^a PFIZER INC   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

PROTEIN;

ARTICLE; CRYSTALLIZATION; FREEZE THAWING; FROZEN SECTION; GLASS TRANSITION TEMPERATURE; MICROBIAL GROWTH; PH; PHASE TRANSITION; SOLUTE; STORAGE TEMPERATURE;

EID: 77953796854     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (11)

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3. Singh SK. Storage considerations as part of the formulation development program for biologics. Am Pharma Rev. 2007;10(3):26-33.
4. Bhatnagar BS, Bogner RH, Pikal MJ. Protein stability during freezing: separation of stresses and mechanisms of protein stabilization. Pharm Dev Technol. 2007;12(5):505-523
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9. Zippelius R. Untersuchung zum Enifrier-und Aufauverhalten Pharmazeutischer Humanproteinlosungen im Grossmasstab. (Investigation of Freezing and Thawing Process of Human Pharmaceutical Protein Solutions at Large Scale). PhD Thesis (in German), Ludwig-Maximilians University, Munich, 2002.
10. Kolhe P, Badkar A. Protein and Solute Distribution in Drug Substance Containers During Frozen Storage As Well As Post-Thawing: A Tool To Understand and Define Freezing-Thawing Parameters in Biotechnology Process Development Submitted 2009.
11. Maity H, Karkaria C, Davagnino J. Mapping of solution components, pH changes, protein stability and the elimination of protein precipitation during freeze-thawing of fibroblast growth factor 20. Int J Pharm. 2009;378(1-2):122- 135.