A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody

Journal of Pharmaceutical Sciences

Volumn 90, Issue 3, 2001, Pages 310-321

  Cleland, Jeffrey L ^a   Lam, Xanthe ^a   Kendrick, Brent ^b   Yang, Janet ^a   Yang, Tzung Horng ^c   Overcashier, David ^a   Brooks, Dennis ^a   Hsu, Chung ^a   Carpenter, John F ^c  

^a GENENTECH INC   (United States)

^b AMGEN INC   (United States)

^c UNIVERSITY OF COLORADO   (United States)

Author keywords

Aggregation; Lyophilization; Monoclonal antibody; Protein stability; Sugars

Indexed keywords

EID: 48149112046     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/1520-6017(200103)90:3<310::AID-JPS6>3.3.CO;2-I     Document Type: Article

References (34)

1. Development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation
2. Stability of protein pharmaceuticals
3. Formulation and delivery of proteins and peptides: Design and development strategies
4. Dehydration-induced conformation transitions in proteins and their inhibition by stabilizers
5. Cryoprotective effects of saccharides on denaturation of catalase by freeze-drying
6. Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid
7. Effects of Tween 20 on agitation- and freeze-thawing-induced aggregation of recombinant human factor XIII
8. Optimization of storage stability of lyophilized actin using combinations of disaccharides and dextran
9. Effect of glass transition temperature on the stability of lyophilized formulations containing a chimeric therapeutic monoclonal antibody
10. Stability of freeze dried horseradish peroxidase conjugated monoclonal antibodies used in diagnostic serology
11. Stabilization of chimeric BR96-doxorubicin immunoconjugate
12. The effect of formulation excipients on protein stability and aerosol performance of spray-dried powders of a recombinant humanized anti-IgE monoclonal antibody
13. Protein inhalation powders: Spray drying vs spray freese drying
14. Lyophilization of protein pharmaceuticals
15. Application of infrared spectroscopy to development of stable lyophilized protein formulations
16. Roles of protein conformation and glassy state in the storage stability of dried protein formulations
17. Optimization of lyophilization conditions for recombinant human interleukin-2 by dried-state conformational analysis using fourier-transform infrared spectroscopy
18. Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding
19. Surface denaturation at solid-void interface - A possible pathway by which opalescent particulates form during the storage of lyophilized tissue-type plasminogen activator at high temperatures
20. Humanization of an anti-p185HER2 antibody for human cancer therapy
21. Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2
22. Identification of multiple sources of charge heterogeneity in a recombinant antibody
23. Protein denaturation during freezing and thawing in phosphate buffer systems: Monomeric and tetrameric β-galactosidase
24. Separation of freezing- and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. I. Enzyme activity and calorimetric studies
25. Development of freeze-dried albumin-free formulation of recombinant factor VIII SQ
26. Protein formulation and lyophilization cycle design: Prevention of damage due to freeze-concentration induced phase separation
27. Characterization of phase transitions during freeze-drying by in-situ X-ray powder diffractometry
28. Formulations of sugars with amino acids or mannitol-Influence of concentration ratio on the properties of the freeze-concentrate and the lyophilizate
29. Use of subambient differential scanning calorimetry to monitor the frozen-state behavior of blends of excipients for freeze-drying
30. Effects of formulation and process variables on the aggregation of freeze-dried interleukin-6 (IL-6) after lyophilization and storage
31. Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying
32. Lyophilized formulations of recombinant tumor necrosis factor
33. The effects of formulation variables on the stability of freeze-dried human growth hormone