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Research ArticleResearch

A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization

Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu and Ankit R. Patel
PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 533-546; DOI: https://doi.org/10.5731/pdajpst.2015.006338
Nina J. Xiao
1Late Stage Pharmaceutical Development and
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Colin D. Medley
2Small Molecule Analytical Quality Control, Genentech Inc., South San Francisco, CA
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Ian C. Shieh
1Late Stage Pharmaceutical Development and
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Gregory Downing
1Late Stage Pharmaceutical Development and
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Shelly Pizarro
1Late Stage Pharmaceutical Development and
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Jun Liu
1Late Stage Pharmaceutical Development and
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Ankit R. Patel
1Late Stage Pharmaceutical Development and
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  • For correspondence: patel.ankit@gene.com
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Article Information

vol. 70 no. 6 533-546
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 
  • Published online December 13, 2016.

Article Versions

  • previous version (June 20, 2016 - 13:19).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Nina J. Xiao1,
  2. Colin D. Medley2,
  3. Ian C. Shieh1,
  4. Gregory Downing1,
  5. Shelly Pizarro1,
  6. Jun Liu1 and
  7. Ankit R. Patel1,*
  1. 1Late Stage Pharmaceutical Development and
  2. 2Small Molecule Analytical Quality Control, Genentech Inc., South San Francisco, CA
  1. ↵* Corresponding Author: Dr. Ankit Patel, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080. Telephone: 650-467-7427; Fax: 650-225-3613; e-mail: patel.ankit{at}gene.com
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PDA Journal of Pharmaceutical Science and Technology: 70 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 6
November/December 2016
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A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu, Ankit R. Patel
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 533-546; DOI: 10.5731/pdajpst.2015.006338

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A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
Nina J. Xiao, Colin D. Medley, Ian C. Shieh, Gregory Downing, Shelly Pizarro, Jun Liu, Ankit R. Patel
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 533-546; DOI: 10.5731/pdajpst.2015.006338
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Keywords

  • Single-use bioprocess container
  • Disposables
  • leachables
  • Protein aggregation
  • Visible and sub-visible particles
  • Stability
  • Capillary electrophoresis
  • Chromatography
  • Surfactants

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