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Research ArticleConference Proceeding - Article

Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation

Brian Hubbard and David Roush
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 51-65; DOI: https://doi.org/10.5731/pdajpst.2014.00966
Brian Hubbard
1Amgen, Inc. Thousand Oaks, CA; and
Ph.D.
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  • For correspondence: hubbardb@amgen.com
David Roush
2Merck Sharp and Dohme, Kenilworth, NJ
Ph.D.
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Article Information

vol. 68 no. 1 51-65
DOI 
https://doi.org/10.5731/pdajpst.2014.00966
PubMed 
24504236

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 6, 2014.

Copyright & Usage 
© PDA, Inc. 2014

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PDA Journal of Pharmaceutical Science and Technology: 68 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
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Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation
Brian Hubbard, David Roush
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 51-65; DOI: 10.5731/pdajpst.2014.00966

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Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation
Brian Hubbard, David Roush
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 51-65; DOI: 10.5731/pdajpst.2014.00966
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  • Article
    • Hydroxyapatite and Mixed-Mode Chromatography (HA/MM) Background
    • Ceramic Hydroxyapatite Chromatography in a Monoclonal Antibody (mAb) Platform Purification Process: Virus Clearance (Eileen Wilson, GlaxoSmithKline)
    • Defining Robust Operating Ranges for Mixed-Mode Chromatography in a mAb Platform Process for Reproducible Viral Clearance (D. Vacante, Johnson & Johnson)
    • Virus Clearance on Capto Adhere® (Sherrie Curtis; Genentech, a Member of the Roche Group)
    • Key Parameters for MuLV Removal by Capto Adhere® Chromatography (Lisa Connell-Crowley, Amgen)
    • Adsorptive Membrane Chromatography Background
    • Determination of the Effect of Impurities on Viral Log Reduction across Q Membrane (Judy Glynn, Paul Mensah, and Kristin Thomas; Pfizer)
    • Challenges in Demonstrating Viral Clearance for AEX Membrane Steps (Scott A. Tobler, Morgan Barth, and David Roush; Merck Sharp and Dohme)
    • Case Studies in AEX Filtration for the Removal of Viruses (Michael Clark; Abbott Bioresearch Center, Worcester, MA)
    • MC Summary
    • UV-C Inactivation and Chemical Precipitation (UV/CP) Background
    • Evaluation and Development of UV-C Viral Inactivation Processing Methods (Joe Shultz, Amgen)
    • Precipitation of MuLV by Caprylate (Lisa Connell-Crowley, Amgen)
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Cited By...

  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations-Purification Unit Operations
  • Session 3.1: Protein A, Hydroxyapatite, and Mixed-Mode Chromatography
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More in this TOC Section

  • Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration
  • Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
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