Liquid formulations for long-term storage of monoclonal IgGs

Applied Biochemistry and Biotechnology

Volumn 169, Issue 4, 2013, Pages 1431-1448

  Mueller, Monika ^a   Loh, Maybelle Q T ^a   Tee, Doris H Y ^a   Yang, Yuansheng ^a   Jungbauer, Alois ^b  

^a AGENCY FOR SCIENCE   (Singapore)

^b UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES   (Austria)

Author keywords

DSC; Formulation; IgG; Long term storage; Stability

Indexed keywords

ACCELERATED STORAGES; CONFORMATIONAL STABILITIES; DSC; FLUORESCENCE ACTIVATED CELL SORTING; FORMULATION; IGG; ISO-ELECTRIC POINTS; LONG-TERM STORAGE;

ALCOHOLS; AMINO ACIDS; CONVERGENCE OF NUMERICAL METHODS; DIFFERENTIAL SCANNING CALORIMETRY; FLOW CYTOMETRY;

LIQUIDS;

GLYCINE; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; SODIUM CHLORIDE; SORBITOL; SUCROSE;

ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG STABILITY; DRUG STORAGE; FLUORESCENCE ACTIVATED CELL SORTING; GEL PERMEATION CHROMATOGRAPHY; IMMUNOREACTIVITY; ISOELECTRIC POINT; LIQUID; PROTEIN DEGRADATION; SHEAR STRESS; THERMOSTABILITY; CHEMISTRY; GEL CHROMATOGRAPHY;

CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GEL; DRUG STABILITY; GLYCINE; IMMUNOGLOBULIN G; SODIUM CHLORIDE; SORBITOL; SUCROSE;

EID: 84882970395     PISSN: 02732289     EISSN: 15590291     Source Type: Journal    
DOI: 10.1007/s12010-012-0084-z     Document Type: Article

References (48)

1. An, Z. (2010). Protein & Cell, 1, 319-330.
2. Wang, W., Nema, S., & Teagarden, D. (2010). International Journal of Pharmaceutics, 390, 89-99.
3. Eng, M., Ling, V., Briggs, J. A., Souza, K., Canova-Davis, E., Powell, M. F., & De Young, L. R. (1997). Analytical Chemistry, 69, 4184-4190.
4. Schrier, J. A., Kenley, R. A., Williams, R., Corcoran, R. J., Kim, Y., Northey, R. P., Jr., D'Augusta, D., & Huberty, M. (1993). Pharmaceutical Research, 10, 933-944.
5. Robert, F., Bierau, H., Rossi, M., Agugiaro, D., Soranzo, T., Broly, H., & Mitchell-Logean, C. (2009). Biotechnology and Bioengineering, 104, 1132-1141.
6. Vanerp, R., Adorf, M., Vansommeren, A. P. G., & Gribnau, T. C. J. (1991). Journal of Biotechnology, 20, 249-262.
7. Fradkin, A. H., Carpenter, J. F., & Randolph, T. W. (2009). Journal of Pharmaceutical Sciences, 98, 3247-3264.
8. van Beers, M. M. C., Jiskoot,W., & Schellekens, H. (2010). Journal of Interferon and Cytokine Research, 30, 767-775.
9. Lee, J. C., & Timasheff, S. N. (1981). Journal of Biological Chemistry, 256, 7193-7201.
10. Xie, G., & Timasheff, S. N. (1997). Protection Science, 6, 211-221.
11. Gekko, K., & Timasheff, S. N. (1981). Biochemistry, 4, 4667-4676.
12. Arakawa, T., & Timasheff, S. N. (1982). Biochemistry, 21, 6545-6552.
13. Arakawa, T., & Timasheff, S. N. (1983). Archives of Biochemistry and Biophysics, 224, 169-177.
14. Han, Y., Jin, B. S., Lee, S. B., Sohn, Y., Joung, J. W., & Lee, J. H. (2007). Archives of Pharmacal Research, 30, 1124-1131.
15. Ohtake, S., Kita, Y., & Arakawa, T. (2011). Advanced Drug Delivery Reviews, 63, 1053-1073.
16. Tiwari, A., & Bhat, R. (2006). Biophysical Chemistry, 124, 90-99.
17. Chen, B., Bautista, R., Yu, K., Zapata, G. A., Mulkerrin, M. G., & Chamow, S. M. (2003). Pharmaceutical Research, 20, 1952-1960.
18. Kerwin, B. A., Heller, M. C., Levin, S. H., & Randolph, T. W. (1998). Journal of Pharmaceutical Sciences, 87, 1062-1068.
19. Cramer, M., Frei, R., Sebald, A., Mazzoletti, P., & Maeder, W. (2009). Vox Sanguinis, 96, 219-225.
20. Kendrick, B. S., Chang, B. S., Arakawa, T., Peterson, B., Randolph, T. W., Manning, M. C., & Carpenter, J. F. (1997). PNAS, 94, 11917-11922.
21. Remmele, R. L., Nightlinger, N. S., Srinivasan, S., & Gombotz, W. R. (1998). Pharmaceutical Research, 15, 9.
22. Back, J. F., Oakenfull, D., & Smith, M. B. (1979). Biochemistry, 18, 5191-5196.
23. Lin, T. Y., & Timasheff, S. N. (1996). Protection Science, 5, 372-381.
24. Kreilgaard, L., Jone, L. S., Randolph, T. W., Frokjaer, S., Flink, J. M., Manning, M. C., & Carpenter, J. F. (1998). Journal of Pharmaceutical Sciences, 87, 1597-1603.
25. Wang, W., Wang, Y. J., & Wand, D. Q. (2008). International Journal of Pharmaceutics, 347, 31-38.
26. Ertel, K. D., & Carstensen, J. T. (1990). International Journal of Pharmaceutics, 61, 9-14.
27. Wang,W., Singh, S., Zeng, D. L., King, K., & Nema, S. (2007). Journal of Pharmaceutical Sciences, 96, 1-26.
28. Vermeer, A. W. P., & Norde, W. (2000). Biophysical Journal, 78, 394-404.
29. Garber, E.,&Demarest, S. J. (2007). Biochemical and Biophysical ResearchCommunications, 355, 751-757.
30. Ionescu, R. M., Vlasak, J., Price, C., & Kirchmeier, M. (2008). Journal of Pharmaceutical Sciences, 97, 1414-1426.
31. Chen, B. L., & Arakawa, T. (1996). Journal of Pharmaceutical Sciences, 85, 419-426.
32. Ahrer, K., Buchacher, A., Iberer, G., & Jungbauer, A. (2006). Journal of Biochemical and Biophysical Methods, 66, 73-86.
33. Szenczi, Á., Kardos, J., Medgyesi, G. A., & Závodszky, P. (2006). Biologicals, 34, 5-14.
34. Choo, A. B., Tan, H. L., Ang, S. N., Fong, W. J., Chin, A., Lo, J., Zheng, L., Hentze, H., Philp, R. J., Oh, S. K., & Yap, M. (2008). Stem Cells, 26, 1454-1463.
35. Ho, S. C. L., Bardor, M., Feng, H., Mariati, Tong, Y. W., Song, Z., Yap, M. G. S., & Yang, Y. (2012). Journal of Biotechnology, 157, 130-139.
36. Choo, A., Padmanabhan, J., Chin, A., Fong,W. J., & Oh, S. K.W. (2006). Journal of Biotechnology, 122, 130-141.
37. Eriksson, L., Johansson, E., Kettaneh-Wold, N., Wikstroem, C., Wold, S. (2008). Umetrics Academy.
38. He, F., Hogan, S., Latypov, R. F., Narhi, L. O., & Razinkov, V. I. (2010). Journal of Pharmaceutical Sciences, 99, 1707-1720.
39. Bhambhani, A., Kissmann, J. M., Joshi, S. B., Volkin, D. B., Kashi, R. S., & Middaugh, C. R. (2011). Journal of Pharmaceutical Sciences, 101, 1120-1135.
40. Zheng, J. Y., & Janis, L. J. (2006). International Journal of Pharmaceutics, 308, 46-51.
41. Li, S., Schöneich, C., & Borchardt, R. T. (1995). Biotechnology and Bioengineering, 48, 490-500.
42. Grinberg, V. Y., Burova, T. V., Grinberg, N. V., Shcherbakova, T. A., Guranda, D. T., Chilov, G. G., & Svedas, V. K. (2008). Biochimica et Biophysica Acta, 1784, 736-746.
43. Pace, C. N., Laurents, D. V., & Thomson, J. A. (1990). Biochemistry, 29, 2564-2572.
44. Pace, C. N., Grimsley, G. R., & Scholtz, J. M. (2009). Journal of Biological Chemistry, 284, 13285-13289.
45. González, M., Murature, D. A., & Fidelio, G. D. (1995). Vox Sanguinis, 68, 1-4.
46. Arakawa, T., Ejima, D., Tsumoto, K., Obeyama, N., Tanaka, Y., Kita, Y., & Timasheff, S. N. (2007). Biophysical Chemistry, 127, 1-8.
47. Welfle, K., Misselwitz, R., Hausdorf, G., Höhne,W., &Welfle, H. (1999). Biochimica et Biophysica Acta, 1431, 120-131.
48. Buchner, J., Renner, M., Lilie, H., Hinz, H. J., Jaenicke, R., Kiefhabel, T., & Rudolph, R. (1991). Biochemistry, 30, 6922-6929.