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.