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Research ArticleResearch

Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes

Michael Ronk, Hans Lee, Kiyoshi Fujimori, Ping Yeh and Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 51-61; DOI: https://doi.org/10.5731/pdajpst.2015.005546
Michael Ronk
1Materials and Systems Analytics, Amgen Inc., Thousand Oaks, CA; and
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  • For correspondence: mronk@amgen.com
Hans Lee
1Materials and Systems Analytics, Amgen Inc., Thousand Oaks, CA; and
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Kiyoshi Fujimori
1Materials and Systems Analytics, Amgen Inc., Thousand Oaks, CA; and
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Ping Yeh
2Drug Product Formulation Technologies, Amgen Inc., Thousand Oaks CA, 91320
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Yasser Nashed-Samuel
1Materials and Systems Analytics, Amgen Inc., Thousand Oaks, CA; and
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References

  1. 1.↵
    1. Nashed-Samuel Y.,
    2. Liu D.,
    3. Fujimori K.,
    4. Perez L.,
    5. Lee H.
    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. Nat. 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), 11–19.
    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, 66 (1), 12–19.
    OpenUrlAbstract/FREE Full Text
  7. 7.↵
    1. Nashed-Samuel Y.
    Extractable and Leachable Implications on Biological Products in Prefilled Syringes. PDA/FDA Joint Regulatory Conference, Washington, DC, September 13–16, 2010.
  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: 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.
    OpenUrlCrossRefPubMed
  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. Redkin A. F.,
    2. Bondarenko G. V.
    Raman spectra of tungsten-bearing solutions. J. Solution Chem. 2010, 39 (10), 1549–1561.
    OpenUrl
  14. 14.↵
    1. Chen Y.-G.,
    2. Gong J.,
    3. Qu L.-Y.
    Tungsten-183 nuclear magnetic resonance spectroscopy in the study of polyoxometalates. Coordination Chemistry Reviews 2004, 248 (1), 245–260.
    OpenUrl
  15. 15.↵
    1. Smith B. J.,
    2. Patrick V. A.
    Quantitative determination of sodium metatungstate speciation by 183W NMR spectroscopy. Australian J. Chem. 2000, 53 (12), 965–970.
    OpenUrl
  16. 16.↵
    1. Brevard C.,
    2. Schimpf R.,
    3. Tourne C. M.
    Tungsten-183 NMR: a complete and unequivocal assignment of the tungsten-tungsten connectivities in heteropolytungstates via two-dimensional 183W NMR techniques. J. Am. Chem. Soc. 1983, 105 (24), 7059–7063.
    OpenUrlCrossRef
  17. 17.↵
    1. Smith B. J.,
    2. Patrick V. A.
    Quantitative determination of sodium dodecatungstosilicate speciation by 183W nuclear magnetic resonance spectroscopy. Australian J. Chem. 2002, 55 (4), 281–286.
    OpenUrl
  18. 18.↵
    1. Zivkovic O.,
    2. Yan C.,
    3. Wagner M. J.
    Tetragonal alkali metal tungsten bronze and hexagonal tungstate nanorods synthesized by alkalide reduction. J. Mater. Chem. 2009, 19 (33), 6029–6033.
    OpenUrl
  19. 19.↵
    1. Reinoso S.,
    2. Giminez-Marques M.,
    3. Galvan-Mascaros J. R.,
    4. Vitoria P.,
    5. Gutierrez-Zorrilla J. M.
    Giant crown-shaped polytungstate formed by self-assembly of CeIII-stabilized dilacunary Keggin fragments. Angew. Chem. Int. Ed. 2010, 49 (45), 8384–8388.
    OpenUrlPubMed
  20. 20.↵
    1. Walanda D. K.,
    2. Burns R. C.,
    3. Lawrance G. A.,
    4. von Nagy-Felsobuki E. I.
    Electrospray mass spectrometry of aqueous solutions of isopolyoxotungstates. J. Cluster Sci. 2000, 11 (1), 5–28.
    OpenUrl
  21. 21.↵
    1. Bednar A. J.,
    2. Kirgan R. A.,
    3. Johnson D. R.,
    4. Hayes C. A.,
    5. McGrath C. J.
    Polytungstate analysis by SEC-ICP-MS direct-infusion ESI-MS. Land Decontamination & Reclamation 2009, 17 (1), 129–137.
    OpenUrl
  22. 22.↵
    1. Truebenbach C. S.,
    2. Houalla M.,
    3. Hercules D. M.
    Characterization of isopoly metal oxyanions using electrospray time-of-flight mass spectrometry. J. Mass Spectrom. 2000, 35 (9), 1121–1127.
    OpenUrlPubMed
  23. 23.↵
    1. Truebenbach C. S.,
    2. Hercules D. M.
    Characterization of isopoly tungstate using time-of-flight electrospray mass spectrometry. Fresenius J. Anal. Chem. 2001, 369 (3-4), 335–341
    OpenUrlPubMed
  24. 24.↵
    1. Ma M. T.,
    2. Waters T.,
    3. Beyer K.,
    4. Palamarczuk R.,
    5. Richardt P. J. S.,
    6. O'Hair R. A. J.,
    7. Wedd A. G.
    Gas-phase fragmentation of polyoxotungstate ions. Inorg. Chem. 2009, 48 (2), 598–606.
    OpenUrlPubMed
  25. 25.↵
    1. Fujimori K.,
    2. Lee. H.,
    3. Phillips J.,
    4. Nashed-Samuel Y.
    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. PDA J. Pharm. Sci. Technol. 2013, 67 (6), 670–679.
    OpenUrlAbstract/FREE Full Text
  26. 26.↵
    1. Christian J. B.,
    2. Whittingham M. S.
    Structural study of ammonium metatungstate. J. Solid State Chem. 2008, 181 (8), 1782–1791.
    OpenUrl
  27. 27.↵
    1. Bonchio M.,
    2. Bortolini O.,
    3. Conte V,
    4. Sartorel A.
    Electrospray behavior of lacunary Keggin-type polyoxotungstates [XW11O39]p− (X=Si, P): mass spectrometric evidence for a concentration-dependent incorporation of an Mon+ (M=WVI, MoVI, VV) unit into the polyoxometalate vacancy. Eur. J. Inorg. Chem. 2003, 4, 699–704.
    OpenUrl
  28. 28.↵
    1. Llopis E.,
    2. Ramirez J. A.,
    3. Cervilla A.
    Tungsten (VI)-gluconic acid complexes: polarimetric and 13C-NMR studies in an excess of tungsten (VI). Transition Met. Chem. 1986, 11 (12), 489–494.
    OpenUrl
  29. 29.↵
    1. Llopis E.,
    2. Ramirez J. A.,
    3. Cervilla A.
    Tungsten-mannitol and sorbitol complexes: structural characterization by IR and carbon-13 nuclear magnetic resonance spectroscopy, Polyhedron 1986, 5 (12), 2069–2074.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 70 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 1
January/February 2016
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Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes
Michael Ronk, Hans Lee, Kiyoshi Fujimori, Ping Yeh, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 51-61; DOI: 10.5731/pdajpst.2015.005546

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Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes
Michael Ronk, Hans Lee, Kiyoshi Fujimori, Ping Yeh, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 51-61; DOI: 10.5731/pdajpst.2015.005546
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Keywords

  • Syringe Extracts
  • Tungsten
  • Tungstate
  • protein aggregation
  • Tungsten Pins
  • Mass spectrometry

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