Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations

Analytical Biochemistry

Volumn 410, Issue 2, 2011, Pages 191-199

  Ludwig, D Brett ^a   Trotter, Joseph T ^b   Gabrielson, John P ^a   Carpenter, John F ^c   Randolph, Theodore W ^a  

^a UCB 450   (United States)

^b BD Technologies   (United States)

^c UNIVERSITY OF COLORADO   (United States)

Author keywords

Adsorption; Flow cytometry; Fluorescence; Formulation; Protein aggregation; Silicone oil

Indexed keywords

ADSORPTION; AGGREGATES; DROPS; EMULSIFICATION; EMULSIONS; FLOW CYTOMETRY; FLUORESCENCE; MAMMALS; MONOCLONAL ANTIBODIES; OSTWALD RIPENING; SODIUM CHLORIDE; SURFACE ACTIVE AGENTS;

BIOPHARMACEUTICAL INDUSTRY; FLOW-CYTOMETRIC ANALYSIS; FLUORESCENCE DETECTION; FORMULATION; PARENTERAL ADMINISTRATION; PARTICLE CHARACTERIZATION; PROTEIN AGGREGATION; SILICONE OIL;

SILICONES;

ABATACEPT; BOVINE SERUM ALBUMIN; LYSOZYME; SILICONE OIL; SODIUM CHLORIDE; SUCROSE; SURFACTANT; TRASTUZUMAB;

ADSORPTION; ARTICLE; DRUG FORMULATION; EMULSION; FLOCCULATION; FLOW CYTOMETRY; FLUORESCENCE; PARTICULATE MATTER; PRIORITY JOURNAL; PROTEIN AGGREGATION;

ALEXA; BOVINAE;

EID: 79551519898     PISSN: 00032697     EISSN: 10960309     Source Type: Journal    
DOI: 10.1016/j.ab.2010.12.008     Document Type: Article

References (36)

1. J.F. Carpenter, T.W. Randolph, W. Jiskoot, D.J. Crommelin, C.R. Middaugh, G. Winter, Y.X. Fan, S. Kirshner, D. Verthelyi, S. Kozlowski, K.A. Clouse, P.G. Swann, A. Rosenberg, and B. Cherney Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality J. Pharm. Sci. 98 2009 1201 1205
2. B.A. Kerwin, M.J. Akers, I. Apostol, C. Moore-Einsel, J.E. Etter, E. Hess, J. Lippincott, J. Levine, A.J. Mathews, P. Revilla-Sharp, R. Schubert, and D.L. Looker Acute and long-term stability studies of deoxy hemoglobin and characterization of ascorbate-induced modifications J. Pharm. Sci. 88 1999 79 88
3. A. Hawe, and W. Friess Stabilization of a hydrophobic recombinant cytokine by human serum albumin J. Pharm. Sci. 96 2007 2987 2999
4. A.K. Tyagi, T.W. Randolph, A. Dong, K.M. Maloney, C. Hitscherich Jr., and J.F. Carpenter IgG particle formation during filling pump operation: a case study of heterogeneous nucleation on stainless steel nanoparticles J. Pharm. Sci. 98 2009 94 104
5. U.S. Pharmacopeia, <7 8 8> Particulate Matter in Injections, U.S. Pharmacopeia-National Formulary, 2006.
6. E.Y. Chi, S. Krishnan, B.S. Kendrick, B.S. Chang, J.F. Carpenter, and T.W. Randolph Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony-stimulating factor Protein Sci. 12 2003 903 913
7. E.Y. Chi, J. Weickmann, J.F. Carpenter, M.C. Manning, and T.W. Randolph Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation J. Pharm. Sci. 94 2005 256 274
8. E. Koren, L.A. Zuckerman, and A.R. Mire-Sluis Immune responses to therapeutic proteins in humans: clinical significance, assessment, and prediction Curr. Pharm. Biotechnol. 3 2002 349 360
9. J. Li, C. Yang, Y. Xia, A. Bertino, J. Glaspy, M. Roberts, and D.J. Kuter Thrombocytopenia caused by the development of antibodies to thrombopoietin Blood 98 2001 3241 3248
10. H. Schellekens Immunogenicity of therapeutic proteins: clinical implications and future prospects Clin. Ther. 24 2002 1720 1740 discussion on p. 1719
11. A. Fries Drug delivery of sensitive biopharmaceuticals with prefilled syringes Drug Deliv. Technol. 9 2009 22 27
12. S. Varaprath, C.L. Frye, and J. Hamelink Aqueous solubility of permethylsiloxanes (silicones) Environ. Toxicol. Chem. 15 1996 1263 1265
13. E.A. Chantelau, and M. Berger Pollution of insulin with silicone oil, a hazard of disposable plastic syringes Lancet 1 1985 1459
14. E. Chantelau, M. Berger, and B. Bohlken Silicone oil released from disposable insulin syringes Diabetes Care 9 1986 672 673
15. R.K. Bernstein Clouding and deactivation of clear (regular) human insulin: association with silicone oil from disposable syringes? Diabetes Care 10 1987 786 787
16. L.S. Jones, A. Kaufmann, and C.R. Middaugh Silicone oil induced aggregation of proteins J. Pharm. Sci. 94 2005 918 927
17. R. Thirumangalathu, S. Krishnan, M.S. Ricci, D.N. Brems, T.W. Randolph, and J.F. Carpenter Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution J. Pharm. Sci. 9 2009 3167 3181
18. D.B. Ludwig, J.F. Carpenter, J.B. Hamel, and T.W. Randolph Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions J. Pharm. Sci. 99 2010 1721 1733
19. H.M. Shapiro Practical Flow Cytometry 1995 Wiley-Liss New York
20. Becton Dickinson, Introduction to Flow Cytometry Web-Based Training, Becton Dickinson, 2005.
21. Bristol-Myers Squib, Orencia [product insert], Bristol-Myers Squib, Princeton, NJ, 2005.
22. Genentech, Herceptin [product insert], Genentech, San Franisco, CA, 2005.
23. K. Hamaguchi, and A. Kurono Structure of muramidase (lysozyme): I. The effect of guanidine hydrochloride on muramidase J. Biochem. 54 1963 111 122
24. T. Peters All about Albumin: Biochemistry, Genetics, and Medical Applications 1995 Academic Press San Diego
25. Bristol-Myers Squib, Orencia [product monograph], Bristol-Myers Squib Canada, Montreal, 2009.
26. A. Cirstoiu-Hapca, L. Bossy-Nobs, F. Buchegger, R. Gurny, and F. Delie Differential tumor cell targeting of anti-HER2 (Herceptin) and anti-CD20 (Mabthera) coupled nanoparticles Intl. J. Pharm. 331 2007 190 196
27. Dow Corning, Dow Corning 360 Medical Fluid [product information], Dow Corning, Midland, MI, 2009.
28. L.S. Cram Flow cytometry: an overview Methods Cell Sci. 24 2002 1 9
29. J.C. Wood Fundamental flow cytometer properties governing sensitivity and resolution Cytometry 33 1998 260 266
30. J. Trotter, The digital flow cytometer: performing instrument characterization for optimal setup, in: BD Biosciences Webinar Series, Becton Dickinson, 2006.
31. E. Dickinson, and D.J. McClements Advances in Food Colloids 1996 Blackie Academic & Professional London
32. V.B. Fainerman, R. Miller, J.K. Ferri, H. Watzke, M.E. Leser, and M. Michel Reversibility and irreversibility of adsorption of surfactants and proteins at liquid interfaces Adv. Colloid Interface Sci. 123-126 2006 163 171
33. M.M. Davis, and H.B. Hetzer Titrimetric and equilibrium studies using indicators related to Nile blue A Anal. Chem. 38 1966 451 461
34. H. Du, R.C.A. Fuh, J.Z. Li, L.A. Corkan, and J.S. Lindsey PhotochemCAD: a computer-aided design and research tool in photochemistry Photochem. Photobiol. 68 1998 141 142
35. N. Panchuk-Voloshina, R.P. Haugland, J. Bishop-Stewart, M.K. Bhalgat, P.J. Millard, F. Mao, and W.Y. Leung Alexa dyes, a series of new fluorescent dyes that yield exceptionally bright, photostable conjugates J. Histochem. Cytochem. 47 1999 1179 1188
36. H. Wiig, C.C. Gyenge, and O. Tenstad The interstitial distribution of macromolecules in rat tumours is influenced by the negatively charged matrix components J. Physiol. 567 2005 557 567