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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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Article Information

vol. 67 no. 4 323-335
DOI 
https://doi.org/10.5731/pdajpst.2013.00925
PubMed 
23872443

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 19, 2013.

Copyright & Usage 
© PDA, Inc. 2013

Author Information

  1. Ge Jiang1,*,
  2. Monica Goss2,
  3. Guiyang Li2,
  4. Wendy Jing2,
  5. Hong Shen2,
  6. Kiyoshi Fujimori2,
  7. Linda Le2,
  8. Lyanne Wong2,
  9. Zai-Qing Wen2,
  10. Yasser Nashed-Samuel2,
  11. Ken Riker1,
  12. Abe Germansderfer3,
  13. Paul Tsang1 and
  14. Margaret Ricci2
  1. 1Global Product Quality, Amgen Inc.;
  2. 2Process and Product Development, Amgen Inc.; and
  3. 3Quality Engineering, Amgen Inc.
  1. ↵* Corresponding Author: Ge Jiang, Ph.D., M.B.A, One Amgen Center Dr. MS 25-2-A, Thousand Oaks, CA. Telephone: 805-313-4894, E-mail: gjiang{at}amgen.com
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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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