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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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Article Information

vol. 74 no. 6 627-643
DOI 
https://doi.org/10.5731/pdajpst.2019.011379
PubMed 
32675308

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 10, 2020.

Article Versions

  • previous version (July 16, 2020 - 07:38).
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Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Michael Ronk1,*,
  2. Jian Liu1,
  3. Alejandra Gallegos1,
  4. Yanxin Luo1,
  5. Kiyoshi Fujimori1,
  6. Kim Li2,
  7. Hans Lee3 and
  8. Yasser Nashed-Samuel1,*
  1. 1Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
  2. 2Environment, Health, Safety and Sustainability, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320; and
  3. 3Los Angeles Trade-Technical College, 400 West Washington Blvd, Los Angeles, CA 90015
  1. ↵* Corresponding Authors: Michael Ronk, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320. Telephone: (805) 447-1352. E-mail: mronk{at}amgen.com; and Yasser Nashed-Samuel, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. Telephone: (805) 447-5483. E-mail: snashed{at}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
November/December 2020
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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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Keywords

  • Extractables
  • Leachables
  • Prefilled syringe
  • Delivery device
  • ICH Q3D

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