Large-scale freezing of biologics: Understanding protein and solute concentration changes in a cryovessel - Part 2

BioPharm International

Volumn 23, Issue 7, 2010, Pages 40-49

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

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PROTEIN;

ARTICLE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG MANUFACTURE; DRUG STORAGE; FREEZING; LARGE SCALE PRODUCTION; OSMOLALITY; SOLUTE; THERMODYNAMICS;

EID: 78650333730     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (10)

1. Tschoepe M, Schmidt R. Impact of freeze/thaw processing on monoclonal antibody stability. Bioprocess International Conference. Vienna, April 2008.
2. 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 fefine freezing-thawing parameters. Biotechnol Proc Devel. Submitted 2009.
3. Lashmar UT, Vanderburgh M, Little SJ. Bulk Freeze-Thawing of macromolecules: effects of cryoconcentration on their formulation and stability. Bioprocess Int. 2007;5(6):44-54.
4. Webb SD, Webb JN, Hughes TG, Sesin DF, Kincaid AC. Freezing biopharmaceutical using common techniques and the magnitude of bulk scale freeze-concentration. Bioprocess Int. 2002;15(5):22-34.
5. Kolhe P, Holding E, Lary A, Chico S, Singh SK. Large-scale freezing of biologics: understanding protein and solute concentration changes in a cryovessel-part I. BioPharm Int. 2010;23(6):53-60.
6. Zippelius R. Untersuchung zum Enifrierund 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.
7. Wisniewski R, Wu VL. Large-Scale Freezing and Thawing of Biopharmaceutical Products. In: Avis KE, Wu VL, ed. Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation Vol 2 of Drug manufacturing technology series: CRC Press, 1996:7-60.
8. Muldrew K, Acker J P, Elliott JAW, McGann LE. The water to ice transition: Implications for living cells. In: Fuller BJ, Benson EE, Lane N, editors. Life in the frozen state. Boca Raton, FL. CRC Press; 2004:67-108.
9. Roos Y, Karel M. Applying state diagrams to food processing and development. Food Technol. 1991 Dec;45 (12):66, 68-71, 107.
10. Singh SK, Kolhe P, Wang W, Nema S. Large-scale freezing of biologics-a practitioner's review part 1: fundamental aspects. Bioprocess Int. 2009;7(10):32-44.