Root cause analysis of tungsten-induced protein aggregation in pre-filled syringes

PDA Journal of Pharmaceutical Science and Technology

Volumn 64, Issue 1, 2010, Pages 11-19

  Liu, Wei ^a   Swift, Rob ^a   Torraca, Gianni ^a   Nashed Samuel, Yasser ^a   Wen, Zai Qing ^a   Jiang, Yijia ^a   Vance, Aylin ^a   Mire Sluis, Anthony ^a   Freund, Erwin ^a   Davis, Janice ^b   Narhi, Linda ^a  

^a AMGEN INC   (United States)

^b WindRose Analytica Inc   (United States)

Author keywords

Biopharmaceuticals; Fill; Finish; Particles; Pre filled syringe; Protein aggregation; Tungsten

Indexed keywords

PROTEIN; TUNGSTEN; SOLUTION AND SOLUBILITY;

AIR; ARTICLE; DRUG PACKAGING; EXTRACTION; INFRARED SPECTROSCOPY; LEACHING; MICROPARTICLE ENZYME IMMUNOASSAY; NEEDLE; PROTEIN AGGREGATION; ROOT CAUSE ANALYSIS; SYRINGE; VACUUM; HUMAN; PACKAGING; SOLUTION AND SOLUBILITY;

HUMANS; PHARMACEUTICAL SOLUTIONS; PRODUCT PACKAGING; PROTEINS; ROOT CAUSE ANALYSIS; SOLUTIONS; SYRINGES; TUNGSTEN; VACUUM;

EID: 78149287596     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Shire, S. J.; Shahrokh, Z.; Liu, J. Challenges in the development of high protein concentration formulations. J. Pharm. Sci. 2004, 93 (6), 1390-1402. (Pubitemid 38725014)
2. Harn, N.; Allan, C.; Oliver, C.; Middaugh, C. R. Highly concentrated monoclonal antibody solutions: direct analysis of physical structure and thermal stability. J. Pharm. Sci. 2007, 96 (3), 532-546.
3. Cromwell, M. E. M.; Hilario, E.; Jacobson, F. Protein aggregation and bioprocessing. AAPS J. 2006, 8 (3), E572-E579.
4. Chi, E. Y.; Krishnan, S.; Randolph, T. W.; Carpenter, J. F. Physical stability of proteins in aqueous solution: mechanism and driving forces in non-native protein aggregation. Pharm. Res. 2003, 20 (9), 1325-1336.
5. Harrison, B.; Rios, M. Big Shot: developments in pre-filled syringes. Pharm. Technol. 2007, 31 (3), 50-56.
6. Walsh, G. Biopharmaceutical benchmarks. Nature Biotechnol. 2006, 24 (7), 769-776.
7. Overcashier, D.; Chan, E.; Hsu, C. Technical considerations in the development of prefilled syringes for protein products. Am. Pharm. Rev. 2006, 9, 77-83.
8. Goldstein, J.; Newbury, D.; Joy, D.; Lyman, C.; Echlin, P.; Lifshin, E.; Sawyer, L.; Michael, J. Scanning Electron Microscopy and X-Ray Microanalysis, 3rd ed., Springer Science + Business Media; New York, 2003.
9. Sadtler Database - IR - Sadtler Inorganics Bio-Rad Laboratories©. 1980; 1981-2007.
10. Jiang, Y.; Nashed-Samuel, Y.; Li, C.; Liu, W.; Pollastrini, J.; Mallard, D.; Wen, Z.; Fujimori, K.; Pallitto, M.; Donahue, L.; Chu, G.; Torraca, G.; Vance, A.; Mire-Sluis, T.; Freund, E.; Davis, J.; Narhi, L. Tungsten-induced protein aggregation II: solution behavior. J. Pharm. Sci. (in press).
11. th ed., Prentice Hall; U.K., 2000.