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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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Abstract

Studies of the extractable profiles of bioprocessing components have become an integral part of drug development efforts to minimize possible compromise in process performance, decrease in drug product quality, and potential safety risk to patients due to the possibility of small molecules leaching out from the components. In this study, an effective extraction solvent system was developed to evaluate the organic extractable profiles of single-use bioprocess equipment, which has been gaining increasing popularity in the biopharmaceutical industry because of the many advantages over the traditional stainless steel-based bioreactors and other fluid mixing and storage vessels. The chosen extraction conditions were intended to represent aggressive conditions relative to the application of single-use bags in biopharmaceutical manufacture, in which aqueous based systems are largely utilized. Those extraction conditions, along with a non-targeted analytical strategy, allowed for the generation and identification of an array of extractable compounds; a total of 53 organic compounds were identified from four types of commercially available single-use bags, the majority of which are degradation products of polymer additives. The success of this overall extractables analysis strategy was reflected partially by the effectiveness in the extraction and identification of a compound that was later found to be highly detrimental to mammalian cell growth.

LAY ABSTRACT: The usage of single-use bioreactors has been increasing in biopharmaceutical industry because of the appealing advantages that it promises regarding to the cleaning, sterilization, operational flexibility, and so on, during manufacturing of biologics. However, compared to its conventional counterparts based mainly on stainless steel, single-use bioreactors are more susceptible to potential problems associated with compound leaching into the bioprocessing fluid. As a result, extractable profiling of the single-use system has become essential in the qualification of such systems for its use in drug manufacturing. The aim of this study is to evaluate the effectiveness of an extraction solvent system developed to study the extraction profile of single-use bioreactors in which aqueous-based systems are largely used. The results showed that with a non-targeted analytical approach, the extraction solvent allowed the generation and identification of an array of extractable compounds from four commercially available single-use bioreactors. Most of extractables are degradation products of polymer additives, among which was a compound that was later found to be highly detrimental to mammalian cell growth.

  • Single-use bioreactor
  • Leachables
  • Extractables
  • Antioxidants
  • Plasticizers
  • © PDA, Inc. 2015
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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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  • Antioxidants
  • Plasticizers

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