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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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Article Information

vol. 69 no. 5 590-619
DOI 
https://doi.org/10.5731/pdajpst.2015.01073
PubMed 
26429108

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 1, 2015.

Copyright & Usage 
© PDA, Inc. 2015

Author Information

  1. Kim Li1,*,
  2. Gary Rogers1,
  3. Yasser Nashed-Samuel1,*,
  4. Hans Lee1,
  5. Anthony Mire-Sluis1,
  6. Barry Cherney1,
  7. Ronald Forster1,
  8. Ping Yeh1 and
  9. Ingrid Markovic2
  1. 1Amgen Inc., Thousand Oaks, California, USA and
  2. 2U.S. Food and Drug Administration (FDA), Washington, DC, USA
  1. ↵*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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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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Keywords

  • Extractables
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  • biotechnology products
  • Single-use systems

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