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Research ArticleResearch

Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations

Ge Jiang, Monica Goss, Guiyang Li, Wendy Jing, Hong Shen, Kiyoshi Fujimori, Linda Le, Lyanne Wong, Zai-Qing Wen, Yasser Nashed-Samuel, Ken Riker, Abe Germansderfer, Paul Tsang and Margaret Ricci
PDA Journal of Pharmaceutical Science and Technology July 2013, 67 (4) 323-335; DOI: https://doi.org/10.5731/pdajpst.2013.00925
Ge Jiang
1Global Product Quality, Amgen Inc.;
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  • For correspondence: gjiang@amgen.com
Monica Goss
2Process and Product Development, Amgen Inc.; and
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Guiyang Li
2Process and Product Development, Amgen Inc.; and
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Wendy Jing
2Process and Product Development, Amgen Inc.; and
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Hong Shen
2Process and Product Development, Amgen Inc.; and
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Kiyoshi Fujimori
2Process and Product Development, Amgen Inc.; and
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Linda Le
2Process and Product Development, Amgen Inc.; and
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Lyanne Wong
2Process and Product Development, Amgen Inc.; and
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Zai-Qing Wen
2Process and Product Development, Amgen Inc.; and
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Yasser Nashed-Samuel
2Process and Product Development, Amgen Inc.; and
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Ken Riker
1Global Product Quality, Amgen Inc.;
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Abe Germansderfer
3Quality Engineering, Amgen Inc.
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Paul Tsang
1Global Product Quality, Amgen Inc.;
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Margaret Ricci
2Process and Product Development, Amgen Inc.; and
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PDA Journal of Pharmaceutical Science and Technology: 67 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 4
July/August 2013
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Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations
Ge Jiang, Monica Goss, Guiyang Li, Wendy Jing, Hong Shen, Kiyoshi Fujimori, Linda Le, Lyanne Wong, Zai-Qing Wen, Yasser Nashed-Samuel, Ken Riker, Abe Germansderfer, Paul Tsang, Margaret Ricci
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 323-335; DOI: 10.5731/pdajpst.2013.00925

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Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations
Ge Jiang, Monica Goss, Guiyang Li, Wendy Jing, Hong Shen, Kiyoshi Fujimori, Linda Le, Lyanne Wong, Zai-Qing Wen, Yasser Nashed-Samuel, Ken Riker, Abe Germansderfer, Paul Tsang, Margaret Ricci
PDA Journal of Pharmaceutical Science and Technology Jul 2013, 67 (4) 323-335; DOI: 10.5731/pdajpst.2013.00925
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