The purpose of this paper is to assess and provide recommendations for reducing volumes required for testing of bioburden and sterility of gene therapy products including considerations for clinical stage and process stage (i.e. in-process vs bulk drug substance (BDS)). This paper makes recommendations for reducing the volumes required for testing and therefore conserving product for patients, while remaining compliant and delivering assay and process information on the microbiological status of gene therapy products.
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A systematic approach for the evaluation, validation, and implementation of automated colony counting systems
This paper describes a systematic approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits.
A BioPhorum member survey looking at sterility and bioburden testing during batch manufacture/release testing of gene therapy products within BioPhorum C> member companies. The results are available to members of BioPhorum C>.
Microbial Control: Detection of Cutibacterium acnes, a high-risk aerotolerant anaerobe recovered in the biopharmaceutical industry
This peer-reviewed paper outlines the risk of aerotolerant anaerobic bacterial contamination during the manufacture of biologic drug substance and the challenges of detection. It examines the issues that manufacturers may consider regarding anaerobic bioburden testing during mammalian cell culture biologics processing, focusing on the detection of aerotolerant anaerobes. It also contains case studies from multiple biopharmaceutical companies, which detected Cutibacterium acnes (C. acnes), the primary anaerobe of concern.
A survey of the BioPhorum Microbial Control Workstream found that more than half of the participants reported contamination events with C. acnes. This survey reported variability in the ability of the compendial microbial enumeration tests to detect C. acnes, thus presenting a challenge for bulk biologics manufacturers. This paper recommends testing conditions designed to increase the likelihood of detecting aerotolerant anaerobe contaminations.