Safe freeze-thaw of protein drug products: A QbD approach

BioPharm International

Volumn 23, Issue 12, 2010, Pages 28-43

  Le Saout, Xavier ^a   Youssef, Eric ^b   Broly, Hervé ^a   Costioli, Matteo D ^a  

^a Merck Serono SA   (Switzerland)

^b SARTORIUS STEDIM BIOTECH GMBH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

INTERFERON; MONOCLONAL ANTIBODY;

ARTICLE; BIOTECHNOLOGICAL PROCEDURES; BIOTECHNOLOGY; CRYSTALLIZATION; DEHYDRATION; DENATURATION; DRUG MANUFACTURE; FREEZING; GROWTH RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INFORMATION PROCESSING; MOLECULAR WEIGHT; OXIDATION; PHARMACEUTICS; PROTEIN AGGREGATION; QUALITY CONTROL; TEMPERATURE; THAWING; VISCOSITY;

EID: 78650328597     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (10)

1. Rathore N, Rajan RS. Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol Prog. 2008;24(3):504-14.
2. Singh SK, Rathore N, McAuley A, Rathore AS. Best practices for formulation and manufacturing of biotech drug products. BioPharm Int. 2009;22(6):32-48.
3. Bhatnagar B, Bogner RH, Pikal MJ. Protein stability during freezing: separation of stresses and mechanisms of protein stabilization. Pharm Dev Technol. 2007;12:505-23.
4. Singh SK, Kolhe P, Wang W, Nema S. Large-scale freezing of biologics: A practitioner's review, part 1-freezing mechanisms. BioProcess Int. 2009;7(9):32-44.
5. Singh SK, Kolhe P, Wang W, Nema S. Large-scale freezing of biologics: A practitioner's review, part 2-freezing mechanisms. BioProcess Int. 2009;7(10):34-42.
6. Webb SD, Webb JN, Hughes TG, Sesin DF, Kincaid AC. Freezing bulk-scale biopharmaceuticals using common techniques and the magnitude of freeze concentration. BioPharm Int. 2002;15(5):22-34.
7. Wisniewski R. Controlled freeze-thaw for biopharmaceuticals. Gen Eng New. 2003;4(23):1-4.
8. Wisniewski R. Large-scale cryopreservation of cells, cell components, and biological solutions. BioPharm Int. 1998;11(9):42-50.
9. Wisniewski R. Developing large-scale cryopreservation systems for biopharmaceutical products. BioPharm Int. 1998;11(6):50-56.
10. Cao E, Chen Y, Foster PR. Effect of freezing and thawing rates on denaturation of proteins in aqueous solutions. Biotechnol Bioeng. 2003;82(6):684-90.