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Research ArticleResearch

Analysis and Evaluation of Single-Use Bag Extractables for Validation in Biopharmaceutical Applications

Ina Pahl, Samuel Dorey, Magali Barbaroux, Bertille Lagrange and Heike Frankl
PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 456-471; DOI: https://doi.org/10.5731/pdajpst.2014.00996
Ina Pahl
aSartorius Stedim Biotech GmbH, Göttingen, Germany; and
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  • For correspondence: ina.pahl@sartorius-stedim.com
Samuel Dorey
bSartorius Stedim Biotech S.A., Z.I. des Paluds, Aubagne, France
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Magali Barbaroux
bSartorius Stedim Biotech S.A., Z.I. des Paluds, Aubagne, France
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Bertille Lagrange
aSartorius Stedim Biotech GmbH, Göttingen, Germany; and
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Heike Frankl
aSartorius Stedim Biotech GmbH, Göttingen, Germany; and
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PDA Journal of Pharmaceutical Science and Technology: 68 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
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Analysis and Evaluation of Single-Use Bag Extractables for Validation in Biopharmaceutical Applications
Ina Pahl, Samuel Dorey, Magali Barbaroux, Bertille Lagrange, Heike Frankl
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 456-471; DOI: 10.5731/pdajpst.2014.00996

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Analysis and Evaluation of Single-Use Bag Extractables for Validation in Biopharmaceutical Applications
Ina Pahl, Samuel Dorey, Magali Barbaroux, Bertille Lagrange, Heike Frankl
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 456-471; DOI: 10.5731/pdajpst.2014.00996
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Keywords

  • Single-use bags
  • Extractables
  • Bioprocessing
  • Additive
  • Degradation products
  • Gamma-irradiated

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