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 Marie Murphy
A1 Brian L. Bell
A1 James Moshi
A1 Rob Grassi
A1 Ren-Yo Forng
A1 Angel Salaman
A1 Petra Wawra Jordi
A1 Simin Zaidi
A1 Marcella Goodnight
A1 Mousumi Paul
A1 Andreas Keller
A1 Bill Carpenter
A1 Una Hearty
A1 Derek Willison-Parry
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.