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Research ArticleResearch

Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products

Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee and Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 627-643; DOI: https://doi.org/10.5731/pdajpst.2019.011379
Michael Ronk
1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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  • For correspondence: mronk@amgen.com snashed@amgen.com
Jian Liu
1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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Alejandra Gallegos
1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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Yanxin Luo
1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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Kiyoshi Fujimori
1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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Kim Li
2Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320; and
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Hans Lee
3Los Angeles Trade-Technical College, 400 West Washington Blvd, Los Angeles, CA 90015
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Yasser Nashed-Samuel
1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
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  • For correspondence: mronk@amgen.com snashed@amgen.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
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Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 627-643; DOI: 10.5731/pdajpst.2019.011379

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Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
Michael Ronk, Jian Liu, Alejandra Gallegos, Yanxin Luo, Kiyoshi Fujimori, Kim Li, Hans Lee, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 627-643; DOI: 10.5731/pdajpst.2019.011379
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