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

Ina Pahl; Samuel Dorey; Magali Barbaroux; Bertille Lagrange; Heike Frankl

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 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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Article Information

vol. 68 no. 5 456-471

DOI

https://doi.org/10.5731/pdajpst.2014.00996

PubMed

25336417

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 21, 2014.

Author Information

Ina Pahla,*,
Samuel Doreyb,
Magali Barbarouxb,
Bertille Lagrangea and
Heike Frankla

^aSartorius Stedim Biotech GmbH, Göttingen, Germany; and
^bSartorius Stedim Biotech S.A., Z.I. des Paluds, Aubagne, France

↵*Corresponding Author: Sartorius Stedim Biotech GmbH, August-Spindler-Straβe 11, D-37079 Göttingen, Germany. Telephone: 0049 (0)551 308 2241; e-mail: ina.pahl{at}sartorius-stedim.com

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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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