Assessing the risk of leachables from single-use bioprocess containers through protein quality characterization

Nina Xiao; Colin D Medley; Ian Shieh; Gregory Downing; Shelly Pizarro; Jun Liu; Ankit R Patel

doi:10.5731/pdajpst.2015.006338

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Assessing the risk of leachables from single-use bioprocess containers through protein quality characterization

Nina Xiao, Colin D Medley, Ian Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R Patel

PDA Journal of Pharmaceutical Science and Technology June 2016, pdajpst.2015.006338; DOI: https://doi.org/10.5731/pdajpst.2015.006338

Nina Xiao

Genentech

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For correspondence: xiao.nina@gene.com

Colin D Medley

Genentech

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For correspondence: medley.colin@gene.com

Ian Shieh

Genentech

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For correspondence: shieh.ian@gene.com

Gregory Downing

Genentech

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For correspondence: downing.gregory@gene.com

Shelly Pizarro

Genentech

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For correspondence: pizarro.shelly@gene.com

Jun Liu

Genentech

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For correspondence: liu.jun@gene.com

Ankit R Patel

Genentech

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For correspondence: patel.ankit@gene.com

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pdajpst.2015.006338

DOI

https://doi.org/10.5731/pdajpst.2015.006338

PubMed

27325598

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received November 29, 2015
Accepted May 28, 2016
Published online June 20, 2016.

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Author Information

Nina Xiao (xiao.nina{at}gene.com),
Colin D Medley (medley.colin{at}gene.com),
Ian Shieh (shieh.ian{at}gene.com),
Gregory Downing (downing.gregory{at}gene.com),
Shelly Pizarro (pizarro.shelly{at}gene.com),
Jun Liu (liu.jun{at}gene.com) and
Ankit R Patel 1 (patel.ankit{at}gene.com)

Genentech

↵* Corresponding author; email: patel.ankit{at}gene.com

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Assessing the risk of leachables from single-use bioprocess containers through protein quality characterization

Nina Xiao, Colin D Medley, Ian Shieh, Gregory Downing, Shelly Pizarro, Jun Liu, Ankit R Patel

PDA Journal of Pharmaceutical Science and Technology Jun 2016, pdajpst.2015.006338; DOI: 10.5731/pdajpst.2015.006338

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Assessing the risk of leachables from single-use bioprocess containers through protein quality characterization

Nina Xiao, Colin D Medley, Ian Shieh, Gregory Downing, Shelly Pizarro, Jun Liu, Ankit R Patel

PDA Journal of Pharmaceutical Science and Technology Jun 2016, pdajpst.2015.006338; DOI: 10.5731/pdajpst.2015.006338

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Keywords

disposable storage bags
leachable induced aggregation
monoclonal antibody
Risk assessment
single-use bioprocess containers
stability

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