Evaluation of the effect of syringe surfaces on protein formulations

Journal of Pharmaceutical Sciences

Volumn 100, Issue 7, 2011, Pages 2563-2573

  Majumdar, Sumit ^a   Ford, Brandi M ^a   Mar, Kevin D ^a   Sullivan, Vince J ^a   Ulrich, Robert G ^b   D'souza, Ajit Joseph M ^a  

^a BD Technologies   (United States)

^b UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

Author keywords

Biotechnology; Materials science; Physical stability; Protein aggregation; Protein formulation

Indexed keywords

MONOCLONAL ANTIBODY; SILICONE OIL; STAPHYLOCOCCUS ENTEROTOXIN B;

ARTICLE; PACKAGING; PROTEIN INTERACTION; SYRINGE;

EID: 79955632231     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22515     Document Type: Article

References (15)

1. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. 2009. Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98(4):1201-1205.
2. Rosenberg AS. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8(3):E501-E507.
3. Purcell RT, Lockey RF. 2008. Immunologic responses to therapeutic biologic agents. J Investig Allergol Clin Immunol 18(5):335-342.
4. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, Cromwell M, Krause HJ, Mahler HC, Meyer BK, Narhi L, Nesta DP, Spitznagel T. 2010. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci 99(8):3302-21.
5. Jones LS, Kaufmann A, Middaugh CR. 2005. Silicone oil induced aggregation of proteins. J Pharm Sci 94(4):918-927.
6. Bee JS, Nelson SA, Freund E, Carpenter JF, Randolph TW. 2009. Precipitation of a monoclonal antibody by soluble tungsten. J Pharm Sci 98(9):3290-3301.
7. Boven K, Stryker S, Knight J, Thomas A, van Regenmortel M, Kemeny DM, Power D, Rossert J, Casadevall N. 2005. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 67(6):2346-2353.
8. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF. 2009. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci 98(9):3167-3181.
9. Ludwig DB, Carpenter JF, Hamel JB, Randolph TW. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci 99(4):1721-1733.
10. Bristol-Myers Squibb. Accessed at: Accessed on February 04, 2011.
11. D'Souza A, Montgomery D. 2010. Medical components having coated surfaces exhibiting low friction and low reactivity. In: USPTO, Ed. Unpublished (filing date Jun 17) BD Technologies.
12. Larkin EA, Stiles BG, Ulrich RG. Inhibition of toxic shock by human monoclonal antibodies against staphylococcal enterotoxin B. PLoS One 5(10):e13253.
13. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G. 2010. Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: Essential need to use orthogonal methods to assure the quality of therapeutic protein products. J Pharm Sci 99(5):2200-2208.
14. Gabrielson JP, Randolph TW, Kendrick BS, Stoner MR. 2007. Sedimentation velocity analytical ultracentrifugation and SEDFIT/c(s): Limits of quantitation for a monoclonal antibody system. Anal Biochem 361(1):24-30.
15. Huang CT, Sharma D, Oma P, Krishnamurthy R. 2009. Quantitation of protein particles in parenteral solutions using micro-flow imaging. J Pharm Sci 98(9):3058-3071.