Publications by authors named "Marcella Goodnight"
Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective.
Brian L Bell
Petra Wawra Jordi
PDA J Pharm Sci Technol 2018 Mar-Apr;72(2):213-221. Epub 2018 Feb 14.
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.
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