A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes

References

1. 1.↵
   Prefilled Syringes Market: (Glass and Plastic) Global Industry Analysis, Size, Volume, Share, Growth, Trends and Forecast, 2013 – 2019, Transparency.
2. 2.↵
   FDA. http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm.
3. 3.↵
   1. Jones L. S.,
   2. Kaufmann A.,
   3. Middaugh C. R.

   Silicone oil induced aggregation of proteins. J. Pharm. Sci. 2005, 94 (4), 918–927.

   OpenUrlPubMed
4. 4.↵
   1. Thirumangalathu R.,
   2. Krishnan S.,
   3. Ricci M. S.,
   4. Brems D. N.,
   5. Randolph T. W.,
   6. Carpenter J. F.

   Silicone oil and agitation-induced aggregation of monoclonal antibody in aqueous solution. J. Pharm. Sci. 2009, 98 (9), 3167–3181.

   OpenUrlCrossRefPubMedWeb of Science
5. 5.↵
   1. Gerhardt A.,
   2. Bonam K.,
   3. Bee J. S.,
   4. Carpenter J. F.,
   5. Randolph T. W.

   Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces. J. Pharm. Sci. 2013, 102 (2), 429–440.

   OpenUrlPubMed
6. 6.↵
   1. Li J.,
   2. Pinnamaneni S.,
   3. Quan Y.,
   4. Jaiswal A.,
   5. Andersson F. I.,
   6. Zhang X.

   Mechanistic understanding of protein–silicone oil interactions. Pharm. Res. 2012, 29 (6), 1689–1697.

   OpenUrlCrossRefPubMed
7. 7.↵
   1. Labrenz S. R.,
   2. Calmann M. A.,
   3. Heavner G. A.,
   4. Tolman G.

   The oxidation of methionine-54 of epoetinum alfa does not affect molecular structure or stability, does decrease biological activity. PDA J. Pharm. Sci. Technol. 2008, 62 (3), 211–223.

   OpenUrlAbstract/FREE Full Text
8. 8.↵
   1. Seidl A.,
   2. Hainzl O.,
   3. Richter M.,
   4. Fischer R.,
   5. Bohm S.,
   6. Deutel B.,
   7. Hartinger M.,
   8. Windisch J.,
   9. Casadevall N.,
   10. London G. M.,
   11. Macdougall I.

   Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm. Res. 2012, 29 (6), 1454–1467.

   OpenUrlCrossRefPubMed
9. 9.↵
   1. Cleland J.

   Powell, M. Shire, S. The development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation. Crit. Rev. Ther. Drug Carrier Syst. 1993, 10 (4), 307–377.

   OpenUrlPubMedWeb of Science
10. 10.↵
    1. Rosenburg A.

    Effects of protein aggregates: an immunologic perspective. AAPS J. 2006, 8 (3), E501–E507.

    OpenUrlCrossRefPubMedWeb of Science
11. 11.↵
    1. Yoshino K.,
    2. Nakamura T.,
    3. Yamashita A.,
    4. Abe Y.,
    5. Iwasaki K.,
    6. Kanazawa Y.,
    7. Funatsu K.,
    8. Yoshimoto T.,
    9. Suzuki S.

    Functional evaluation and characterization of a newly developed silicone oil–free prefillable syringe system. J. Pharm. Sci. 2014, 103 (5), 1520–1528.

    OpenUrlPubMed
12. 12.↵
    1. Ohta M.,
    2. Kawasaki N.,
    3. Hyuga S.,
    4. Hyuga M.,
    5. Hayakawa T.

    Selective glycopeptide mapping of erythropoietin by on-line high-performance liquid chromatography–electrospray ionization mass spectrometry. J. Chromatogr., A 2001, 910 (1), 1–11.

    OpenUrlPubMed
13. 13.↵
    1. Scott P. V.,
    2. Horton J. N.,
    3. Mapleson W. W.

    Leakage of oxygen from blood and water samples stored in plastic and glass syringes. Br. Med. J. 1971, 3 (5773), 512–516.

    OpenUrlAbstract/FREE Full Text