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Research ArticleTechnology/Application

Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products

Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh and Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 590-619; DOI: https://doi.org/10.5731/pdajpst.2015.01073
Kim Li
1Amgen Inc., Thousand Oaks, California, USA and
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  • For correspondence: kim.li@amgen.com snashed@amgen.com
Gary Rogers
1Amgen Inc., Thousand Oaks, California, USA and
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Yasser Nashed-Samuel
1Amgen Inc., Thousand Oaks, California, USA and
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  • For correspondence: kim.li@amgen.com snashed@amgen.com
Hans Lee
1Amgen Inc., Thousand Oaks, California, USA and
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Anthony Mire-Sluis
1Amgen Inc., Thousand Oaks, California, USA and
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Barry Cherney
1Amgen Inc., Thousand Oaks, California, USA and
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Ronald Forster
1Amgen Inc., Thousand Oaks, California, USA and
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Ping Yeh
1Amgen Inc., Thousand Oaks, California, USA and
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Ingrid Markovic
2U.S. Food and Drug Administration (FDA), Washington, DC, USA
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PDA Journal of Pharmaceutical Science and Technology: 69 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 5
September/October 2015
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Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 590-619; DOI: 10.5731/pdajpst.2015.01073

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Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh, Ingrid Markovic
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 590-619; DOI: 10.5731/pdajpst.2015.01073
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