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Article CommentaryCommentary

Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective

Marie Murphy, Brian L. Bell, James Moshi, Rob Grassi, Ren-Yo Forng, Angel Salaman, Petra Wawra Jordi, Simin Zaidi, Marcella Goodnight, Mousumi Paul, Andreas Keller, Bill Carpenter, Una Hearty and Derek Willison-Parry
PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 213-221; DOI: https://doi.org/10.5731/pdajpst.2017.008045
Marie Murphy
Research Scientist, Microbiology/Virology, Operations, Eli Lilly&Co
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Brian L. Bell
Manager, Process Microbiology, MS&T, Bristol-Myers Squibb
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James Moshi
QC Scientist II, Astra Zeneca
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Rob Grassi
Global Contamination Specialist, Lonza
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Ren-Yo Forng
Amgen
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Angel Salaman
Janssen
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Petra Wawra Jordi
Senior Manager, Operations, Merck KGaA
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Simin Zaidi
Director, Manufacturing Sciences, Catalent Biologics
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Marcella Goodnight
Astra Zeneca
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Mousumi Paul
Director Manufacturing and Quality, Center of Expertise - Microbiology, MSD
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Andreas Keller
MSD
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Bill Carpenter
Manager, QC Microbiology, Biogen
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Una Hearty
Pfizer
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Derek Willison-Parry
BPOG
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  • For correspondence: derek@biophorum.com
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Article Information

vol. 72 no. 2 213-221
DOI 
https://doi.org/10.5731/pdajpst.2017.008045
PubMed 
29444992

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online March 23, 2018.

Article Versions

  • previous version (February 14, 2018 - 18:16).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Marie Murphy,
  2. Brian L. Bell,
  3. James Moshi,
  4. Rob Grassi,
  5. Ren-Yo Forng,
  6. Angel Salaman,
  7. Petra Wawra Jordi,
  8. Simin Zaidi,
  9. Marcella Goodnight,
  10. Mousumi Paul,
  11. Andreas Keller,
  12. Bill Carpenter,
  13. Una Hearty and
  14. Derek Willison-Parry*
  1. Research Scientist, Microbiology/Virology, Operations, Eli Lilly&Co
  2. Manager, Process Microbiology, MS&T, Bristol-Myers Squibb
  3. QC Scientist II, Astra Zeneca
  4. Global Contamination Specialist, Lonza
  5. Amgen
  6. Janssen
  7. Senior Manager, Operations, Merck KGaA
  8. Director, Manufacturing Sciences, Catalent Biologics
  9. Astra Zeneca
  10. Director Manufacturing and Quality, Center of Expertise - Microbiology, MSD
  11. MSD
  12. Manager, QC Microbiology, Biogen
  13. Pfizer
  14. BPOG
  1. ↵* Corresponding Author: Derek Willison-Parry, BPOG, 5 Westbrook Court, Sharrowvale Rd, Sheffield, S11 8YZ UK; e-mail: derek{at}biophorum.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
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Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective
Marie Murphy, Brian L. Bell, James Moshi, Rob Grassi, Ren-Yo Forng, Angel Salaman, Petra Wawra Jordi, Simin Zaidi, Marcella Goodnight, Mousumi Paul, Andreas Keller, Bill Carpenter, Una Hearty, Derek Willison-Parry
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 213-221; DOI: 10.5731/pdajpst.2017.008045

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Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective
Marie Murphy, Brian L. Bell, James Moshi, Rob Grassi, Ren-Yo Forng, Angel Salaman, Petra Wawra Jordi, Simin Zaidi, Marcella Goodnight, Mousumi Paul, Andreas Keller, Bill Carpenter, Una Hearty, Derek Willison-Parry
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 213-221; DOI: 10.5731/pdajpst.2017.008045
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  • Article
    • Abstract
    • Introduction
    • Purpose of Industry Survey
    • BPOG Survey Method and Participation
    • Survey Results & Discussion
    • Best Practices for Affinity Capture Resin Storage
    • Best Practices for Control of Process Inputs
    • Chromatography Equipment and Soft Parts Management
    • Effective Resin Sanitization
    • Effective Remediation Measures for a Suspected Bioburden Event
    • Best Practices for Affinity Capture Packing and Unpacking Operations
    • Conclusion
    • Conflict of Interest Declaration
    • Acknowledgments
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
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