Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers

Matthew Hammond; Heather Nunn; Gary Rogers; Hans Lee; Anatolia-Liliana Marghitoiu; Lourdes Perez; Yasser Nashed-Samuel; Carl Anderson; Michael Vandiver; Sally Kline

doi:10.5731/pdajpst.2013.00905

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Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers

Matthew Hammond, Heather Nunn, Gary Rogers, Hans Lee, Anatolia-Liliana Marghitoiu, Lourdes Perez, Yasser Nashed-Samuel, Carl Anderson, Michael Vandiver and Sally Kline

PDA Journal of Pharmaceutical Science and Technology March 2013, 67 (2) 123-134; DOI: https://doi.org/10.5731/pdajpst.2013.00905

Matthew Hammond

‡Product Attribute Sciences;

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For correspondence: mhammond@amgen.com

Heather Nunn

§Cell Sciences & Technology, Amgen Inc., Seattle, WA; and

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Gary Rogers

‡Product Attribute Sciences;

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Hans Lee

|Product Contact Assessment;

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Anatolia-Liliana Marghitoiu

|Product Contact Assessment;

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Lourdes Perez

|Product Contact Assessment;

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Yasser Nashed-Samuel

|Product Contact Assessment;

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Carl Anderson

∧Pilot Plant Operations, Amgen Inc., Bothell, WA

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Michael Vandiver

∧Pilot Plant Operations, Amgen Inc., Bothell, WA

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Sally Kline

†Materials Science, Amgen Inc., Thousand Oaks, CA;

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Article Information

vol. 67 no. 2 123-134

DOI

https://doi.org/10.5731/pdajpst.2013.00905

PubMed

23569073

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online April 8, 2013.

Author Information

Matthew Hammond‡,*,
Heather Nunn§,
Gary Rogers‡,
Hans Lee|,
Anatolia-Liliana Marghitoiu|,
Lourdes Perez|,
Yasser Nashed-Samuel|,
Carl Anderson∧,
Michael Vandiver∧ and
Sally Kline†

^‡Product Attribute Sciences;
^|Product Contact Assessment;
^†Materials Science, Amgen Inc., Thousand Oaks, CA;
^§Cell Sciences & Technology, Amgen Inc., Seattle, WA; and
^∧Pilot Plant Operations, Amgen Inc., Bothell, WA

↵* Correspondence author: Matthew Hammond, Mail Stop 30E-1-C, 1 Amgen Center Dr., Thousand Oaks, CA 91320; Tel: (805) 447-6625; Email: mhammond{at}amgen.com

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Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers

Matthew Hammond, Heather Nunn, Gary Rogers, Hans Lee, Anatolia-Liliana Marghitoiu, Lourdes Perez, Yasser Nashed-Samuel, Carl Anderson, Michael Vandiver, Sally Kline

PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 123-134; DOI: 10.5731/pdajpst.2013.00905

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Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers

Matthew Hammond, Heather Nunn, Gary Rogers, Hans Lee, Anatolia-Liliana Marghitoiu, Lourdes Perez, Yasser Nashed-Samuel, Carl Anderson, Michael Vandiver, Sally Kline

PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 123-134; DOI: 10.5731/pdajpst.2013.00905

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Keywords

Bioprocess container
Extractables
Leachables
Cell growth
Polyethylene
Irgafos

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