TY - JOUR T1 - Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 213 LP - 221 DO - 10.5731/pdajpst.2017.008045 VL - 72 IS - 2 AU - Marie Murphy AU - Brian L. Bell AU - James Moshi AU - Rob Grassi AU - Ren-Yo Forng AU - Angel Salaman AU - Petra Wawra Jordi AU - Simin Zaidi AU - Marcella Goodnight AU - Mousumi Paul AU - Andreas Keller AU - Bill Carpenter AU - Una Hearty AU - Derek Willison-Parry Y1 - 2018/03/01 UR - http://journal.pda.org/content/72/2/213.abstract N2 - 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. ER -