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Research ArticleResearch

Extractables Analysis of Single-Use Flexible Plastic Biocontainers

Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001
Liliana Marghitoiu
‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
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Jian Liu
‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
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Hans Lee
‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
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Lourdes Perez
‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
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Kiyoshi Fujimori
‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
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Michael Ronk
‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
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Matthew R. Hammond
§Product Attribute Sciences, Amgen Inc., Thousand Oaks, CA;
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Heather Nunn
|Cell Sciences & Technology, Amgen Inc., Seattle, WA; and
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Asher Lower
̂Small Molecule Process and Product Development, Amgen Inc., Thousand Oaks, CA
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Gary Rogers
§Product Attribute Sciences, Amgen Inc., Thousand Oaks, CA;
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Yasser Nashed-Samuel
‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
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  • For correspondence: snashed@amgen.com
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Article Information

vol. 69 no. 1 49-58
DOI 
https://doi.org/10.5731/pdajpst.2015.01001
PubMed 
25691714

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 17, 2015.

Copyright & Usage 
© PDA, Inc. 2015

Author Information

  1. Liliana Marghitoiu‡,
  2. Jian Liu‡,
  3. Hans Lee‡,
  4. Lourdes Perez‡,
  5. Kiyoshi Fujimori‡,
  6. Michael Ronk‡,
  7. Matthew R. Hammond§,
  8. Heather Nunn|,
  9. Asher Lower̂,
  10. Gary Rogers§ and
  11. Yasser Nashed-Samuel‡,*
  1. ‡Drug Product Development, Amgen Inc., Thousand Oaks, CA;
  2. §Product Attribute Sciences, Amgen Inc., Thousand Oaks, CA;
  3. |Cell Sciences & Technology, Amgen Inc., Seattle, WA; and
  4. ̂Small Molecule Process and Product Development, Amgen Inc., Thousand Oaks, CA
  1. ↵*Corresponding Author: Yasser Nashed-Samuel, Mail Stop 30E-1-C, 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: 69 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
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Extractables Analysis of Single-Use Flexible Plastic Biocontainers
Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 49-58; DOI: 10.5731/pdajpst.2015.01001

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Extractables Analysis of Single-Use Flexible Plastic Biocontainers
Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers, Yasser Nashed-Samuel
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 49-58; DOI: 10.5731/pdajpst.2015.01001
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Keywords

  • Single-use bioreactor
  • Leachables
  • Extractables
  • Antioxidants
  • Plasticizers

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