RT Journal Article SR Electronic 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 FD Parenteral Drug Association (PDA) SP 213 OP 221 DO 10.5731/pdajpst.2017.008045 VO 72 IS 2 A1 Murphy, Marie A1 Bell, Brian L. A1 Moshi, James A1 Grassi, Rob A1 Forng, Ren-Yo A1 Salaman, Angel A1 Jordi, Petra Wawra A1 Zaidi, Simin A1 Goodnight, Marcella A1 Paul, Mousumi A1 Keller, Andreas A1 Carpenter, Bill A1 Hearty, Una A1 Willison-Parry, Derek YR 2018 UL http://journal.pda.org/content/72/2/213.abstract 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.