A comparison of vials with ampoules for the storage of biological reference materials

Biologicals

Volumn 33, Issue 2, 2005, Pages 63-70

  Matejtschuk, Paul ^a   Rafiq, Shakeel ^a,b   Johnes, Suzanne ^a   Das, Rose Gaines ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b UNIVERSITY OF HERTFORDSHIRE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; BIOMATERIAL; OXYGEN;

AMPOULE; ARTICLE; ATMOSPHERE; FREEZE DRYING; GAS; MOISTURE; OXIDATION; PRIORITY JOURNAL; STORAGE TEMPERATURE; STRESS; THERMAL ANALYSIS;

BIOLOGICAL PRODUCTS; FREEZE DRYING; REFERENCE STANDARDS;

EID: 20444371030     PISSN: 10451056     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biologicals.2004.12.002     Document Type: Article

References (13)

1. I. Roy, and M.N. Gupta Freeze drying of proteins: some emerging concerns Biotechnol Appl Biochem 39 2004 65 77
2. M.C. Lai, and E.M. Topp Solid state chemical stability of proteins and peptides J Pharm Sci 88 1999 489 500
3. S.U. Sane, R. Wong, and C.C. Hsu Raman spectroscopic characterization of drying-induced structural changes in a therapeutic antibody: correlation of structural changes with long term stability J Pharm Sci 93 2004 1005 1018
4. M.J. Hageman Water sorption and solid-state stability T.J. Ahern M.C. Manning Stability of protein pharmaceuticals part A: chemical and physical pathways of protein degradation 1992 Plenum New York 273 309
5. C.C. Hsu, C.A. Ward, R. Pearlman, H.M. Nguyen, D.A. Yeung, and J.G. Curley Determining the optimum residual moisture in lyophilized protein pharmaceuticals Dev Biol Stand 74 1992 255 271
6. M.J. Pikal, K. Dellerman, and M.L. Roy Formulation and stability of freeze dried proteins: effects of moisture and oxygen on the stability of freeze dried formulations of human growth hormone Dev Biol Stand 74 1992 21 28
7. P. Matejtschuk, M. Andersen, and P. Phillips Freeze drying of biological standards L. Rey J.C. May Freeze drying/lyophilization of biological and pharmaceutical products 2nd ed. 2004 Marcel Dekker New York 385 424
8. WHO Guidelines for the preparation, characterization and establishment of international and other standards and reference reagents for biological standardization WHO Tech Rep Ser 800 1990 181 214
9. M. Pikal, and S. Shah Moisture transfer from stopper to product and resulting stability implications Dev Biol Stand 74 1992 165 179
10. A.W. Ford, and P.J. Dawson Effect of type of container, storage temperature and humidity on the biological activity of freeze dried alkaline phosphatase Biologicals 22 1994 191 197
11. M.S. Hora, and S.N. Wolfe Critical steps in the preparation of elastomeric closures for biopharmaceutical freeze-dried products L. Rey J.C. May Freeze drying/lyophilization of biological and pharmaceutical products 2nd ed. 2004 Marcel Dekker New York 309 323
12. P.K. Phillips, P.J. Dawson, and A. Delderfield Use of DIN glass ampoules to freeze-dry biological materials with a low residual moisture and oxygen content Biologicals 19 1991 219 221
13. F.L. De Grazzio Closure and container considerations in lyophilization L. Rey J.C. May Freeze drying/lyophilization of biological and pharmaceutical products 2nd ed. 2004 Marcel Dekker New York 277 297