Development of an Inductively Coupled Plasma Mass Spectrometry Method for Quantification of Extracted Tungsten from Glass Prefilled Syringes Used as a Primary Packaging for Pharmaceutical and Therapeutic Protein Products

References

1. 1.↵
   1. Nashed-Samuel Y.,
   2. Liu D.,
   3. Fujimori K.,
   4. Perez L.,
   5. Lee H.

   Prefilled syringes/extractables & leachables—extractable and leachable implications on biological products in prefilled syringes. Am. Pharm. Rev. 2011, 14 (1), 74.

   OpenUrl
2. 2.↵
   1. Harrison B.,
   2. Rios M.

   Big shot: developments in pre-filled syringes, Pharm. Technol. 2007, 31 (3), 50–56.

   OpenUrl
3. 3.↵
   1. Walsh G.

   Biopharmaceutical benchmarks. Nature Biotechnol. 2006, 24 (7), 769 –776.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Liu W.,
   2. Swift R.,
   3. Torraca G.,
   4. Nashed-Samuel Y.,
   5. Wen Z.,
   6. Vance A.,
   7. Mire-Sluis A.,
   8. Freund E.,
   9. Davis J.,
   10. Narhi L.

   Root cause analysis of tungsten-induced protein aggregation in pre-filled syringes. PDA J. Pharm. Sci. Technol. 2010, 64 (1), 11.

   OpenUrlAbstract/FREE Full Text
5. 5.↵
   1. Nashed-Samuel Y.,
   2. Torraca G.,
   3. Liu D.,
   4. Fujimori K.,
   5. Zhang Z.,
   6. Wen Z.-Q.,
   7. Lee H.

   Identification of an extraneous black particle in a glass syringe: extractables/leachables case study. PDA J. Pharm. Sci. Technol. 2010, 64 (3), 242–248.

   OpenUrlAbstract/FREE Full Text
6. 6.↵
   1. Liu D.,
   2. Nashed-Samuel Y.,
   3. Bondarenko P. V.,
   4. Brems D. N.,
   5. Ren D.

   Interactions between therapeutic proteins and acrylic acid leachable. PDA J. Pharm. Sci. Technol. 2012, in press.
7. 7.↵
   1. Nashed-Samuel Y.

   Extractable and Leachable Implications on Biological Products in Prefilled Syringes, PDA/FDA Joint Regulatory Conference, September 13–16, 2010, Washington, DC.
8. 8.↵
   1. Jiang Y.,
   2. Nashed-Samuel Y.,
   3. Li C.,
   4. Liu W.,
   5. Pollastrini J.,
   6. Mallard D.,
   7. Wen Z.,
   8. Fujimori K.,
   9. Pallitto M.,
   10. Donahue L.,
   11. Chu G.,
   12. Torraca G.,
   13. Vance A.,
   14. Mire-Sluis T.,
   15. Freund E.,
   16. Davis J.,
   17. Narhi L.

   Tungsten-induced protein aggregation II: solution behavior. J. Pharm. Sci. 2009, 98 (12), 4695–4710.

   OpenUrlCrossRefPubMed
9. 9.↵
   1. Bee J. S.,
   2. Nelson S. A.,
   3. Freund E.,
   4. Carpenter J. F.,
   5. Randolph T. W.

   Precipitation of a monoclonal antibody by soluble tungsten. J. Pharm Sci. 2009, 98 (9), 3290–3301.

   OpenUrlCrossRefPubMed
10. 10.↵
    1. Seidl A.,
    2. Hainzl O.,
    3. Richter M.,
    4. Fischer R.,
    5. Böhm 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
11. 11.↵
    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
12. 12.↵
    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 a monoclonal antibody in aqueous solution. J. Pharm. Sci. 2009, 98 (9) 3167–3181.

    OpenUrlCrossRefPubMedWeb of Science
13. 13.↵
    1. Beauchemin D.

    Inductively coupled plasma mass spectrometry. Anal. Chem. 2006, 78 (12), 4111–4136

    OpenUrlPubMed
14. 14.↵
    1. Dermatas D.,
    2. Braida W.,
    3. Christodoulatos C.,
    4. Strigul N.,
    5. Panikov N.,
    6. Los M.,
    7. Larson S.

    Solubility, sorption, and soil respiration effects of tungsten and tungsten alloys. Environmental Forensics 2004, 5 (1), 5–13.

    OpenUrlCrossRefWeb of Science
15. 15.↵
    Perkin Elmer. Elan Version 3.0 Software Guide (Part Number 1006920), 2003.
16. 16.↵
    United States Department of Health and Human Service, Food and Drug Administration Guidance for Industry Q2B Validation of Analytical Procedures: Methodology, 1996.