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
Gary Rogers
1Amgen Inc., Thousand Oaks, California, USA and
Yasser Nashed-Samuel
1Amgen Inc., Thousand Oaks, California, USA and
Hans Lee
1Amgen Inc., Thousand Oaks, California, USA and
Anthony Mire-Sluis
1Amgen Inc., Thousand Oaks, California, USA and
Barry Cherney
1Amgen Inc., Thousand Oaks, California, USA and
Ronald Forster
1Amgen Inc., Thousand Oaks, California, USA and
Ping Yeh
1Amgen Inc., Thousand Oaks, California, USA and
Ingrid Markovic
2U.S. Food and Drug Administration (FDA), Washington, DC, USA

Article Information
vol. 69 no. 5 590-619
PubMed
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History
- Published online October 1, 2015.
Copyright & Usage
© PDA, Inc. 2015
Author Information
- Kim Li1,*,
- Gary Rogers1,
- Yasser Nashed-Samuel1,*,
- Hans Lee1,
- Anthony Mire-Sluis1,
- Barry Cherney1,
- Ronald Forster1,
- Ping Yeh1 and
- Ingrid Markovic2
- 1Amgen Inc., Thousand Oaks, California, USA and
- 2U.S. Food and Drug Administration (FDA), Washington, DC, USA
- ↵*Corresponding Authors: Kim Li, Amgen Inc., One Amgen Center Drive, M/S 28-1-A, Thousand Oaks, CA 91320, e-mail: kim.li{at}amgen.com; Yasser Nashed-Samuel, Amgen Inc., One Amgen Center Drive, M/S 30E-1-C, Thousand Oaks, CA 91320, e-mail: snashed{at}amgen.com
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 5
September/October 2015
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
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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