PT  - JOURNAL ARTICLE
AU  - Murphy, Marie
AU  - Bell, Brian L.
AU  - Moshi, James
AU  - Grassi, Rob
AU  - Forng, Ren-Yo
AU  - Salaman, Angel
AU  - Jordi, Petra Wawra
AU  - Zaidi, Simin
AU  - Goodnight, Marcella
AU  - Paul, Mousumi
AU  - Keller, Andreas
AU  - Carpenter, Bill
AU  - Hearty, Una
AU  - Willison-Parry, Derek
TI  - Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective
AID  - 10.5731/pdajpst.2017.008045
DP  - 2018 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 213--221
VI  - 72
IP  - 2
4099  - http://journal.pda.org/content/72/2/213.short
4100  - http://journal.pda.org/content/72/2/213.full
SO  - PDA J Pharm Sci Technol2018 Mar 01; 72
AB  - The purpose of this paper is to provide a summary of a BPOG-led industry survey of the microbiological control aspects of affinity chromatography processing in the biopharmaceutical industry. The document provides a summary of historical microbiological control concerns, coupled with industry-derived best practices, for material, equipment, and storage controls required to mitigate the potential for microbial ingress and contamination of chromatography resin and equipment. These best practice guidelines, which are derived from the members of the BPOG Bioburden Working Group, are intended to assist biopharmaceutical manufacturers to enhance microbial control and monitoring strategies for chromatography systems.