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
Brian L. Bell
Manager, Process Microbiology, MS&T, Bristol-Myers Squibb
James Moshi
QC Scientist II, Astra Zeneca
Rob Grassi
Global Contamination Specialist, Lonza
Ren-Yo Forng
Amgen
Angel Salaman
Janssen
Petra Wawra Jordi
Senior Manager, Operations, Merck KGaA
Simin Zaidi
Director, Manufacturing Sciences, Catalent Biologics
Marcella Goodnight
Astra Zeneca
Mousumi Paul
Director Manufacturing and Quality, Center of Expertise - Microbiology, MSD
Andreas Keller
MSD
Bill Carpenter
Manager, QC Microbiology, Biogen
Una Hearty
Pfizer
Derek Willison-Parry
BPOG

Reference
- 1.↵PDA Technical Report No. 69—Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations; Parenteral Drug Association: Bethesda, MD, 2015.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
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
Jump to section
- 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
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