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1

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

Ronk M, Lee H, Fujimori K, Yeh P, Nashed-Samuel Y. Ronk M, et al. PDA J Pharm Sci Technol. 2016 Jan-Feb;70(1):51-61. doi: 10.5731/pdajpst.2015.005546. Epub 2016 Jan 21. PDA J Pharm Sci Technol. 2016. PMID: 26797967

2

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.

Fujimori K, Lee H, Phillips J, Nashed-Samuel Y. Fujimori K, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):670-9. doi: 10.5731/pdajpst.2013.00941. PDA J Pharm Sci Technol. 2013. PMID: 24265307

3

Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes.

Lu X, Lloyd DK, Klohr SE. Lu X, et al. PDA J Pharm Sci Technol. 2016 Jan-Feb;70(1):39-50. doi: 10.5731/pdajpst.2015.006015. PDA J Pharm Sci Technol. 2016. PMID: 26889055

4

Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

Simonetti A, Amari F. Simonetti A, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):108-22. doi: 10.5731/pdajpst.2015.01004. PDA J Pharm Sci Technol. 2015. PMID: 25691719

5

Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System.

Shi GH, Gopalrathnam G, Shinkle SL, Dong X, Hofer JD, Jensen EC, Rajagopalan N. Shi GH, et al. PDA J Pharm Sci Technol. 2018 Jan-Feb;72(1):50-61. doi: 10.5731/pdajpst.2017.008169. Epub 2017 Oct 12. PDA J Pharm Sci Technol. 2018. PMID: 29030531

6

Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes.

Liu W, Swift R, Torraca G, Nashed-Samuel Y, Wen ZQ, Jiang Y, Vance A, Mire-Sluis A, Freund E, Davis J, Narhi L. Liu W, et al. PDA J Pharm Sci Technol. 2010 Jan-Feb;64(1):11-9. PDA J Pharm Sci Technol. 2010. PMID: 21501999

7

Tungsten-induced protein aggregation: solution behavior.

Jiang Y, Nashed-Samuel Y, Li C, Liu W, Pollastrini J, Mallard D, Wen ZQ, Fujimori K, Pallitto M, Donahue L, Chu G, Torraca G, Vance A, Mire-Sluis T, Freund E, Davis J, Narhi L. Jiang Y, et al. J Pharm Sci. 2009 Dec;98(12):4695-710. doi: 10.1002/jps.21778. J Pharm Sci. 2009. PMID: 19645002

8

Effect of Various Silicone Oil And Tungsten Levels on the Stability of a Monoclonal Antibody in Nine Commercially Available Prefilled Syringes.

Murphy MI, Leissa JA, Plata SB, Chamberlain AL, Patel SM. Murphy MI, et al. J Pharm Sci. 2023 Jun;112(6):1586-1594. doi: 10.1016/j.xphs.2023.03.009. Epub 2023 Mar 17. J Pharm Sci. 2023. PMID: 36933655

9

Tungsten speciation and toxicity: acute toxicity of mono- and poly-tungstates to fish.

Strigul N, Koutsospyros A, Christodoulatos C. Strigul N, et al. Ecotoxicol Environ Saf. 2010 Feb;73(2):164-71. doi: 10.1016/j.ecoenv.2009.08.016. Ecotoxicol Environ Saf. 2010. PMID: 19836837

10

Identification of an extraneous black particle in a glass syringe: extractables/leachables case study.

Nashed-Samuel Y, Torraca G, Liu D, Fujimori K, Zhang Z, Wen ZQ, Lee H. Nashed-Samuel Y, et al. PDA J Pharm Sci Technol. 2010 May-Jun;64(3):242-8. PDA J Pharm Sci Technol. 2010. PMID: 21502024

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