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Changes to BioPhorum extractables protocol

Changes to BioPhorum extractables protocol

The BioPhorum Extractables team has shown the benefits of great collaboration between biomanufacturers and suppliers – they agreed to significantly reduce extractables testing for single-use systems. This decision was made possible by the supply base’s considerable body of data generated through the existing protocol and the biomanufacturer team’s work over the last 12 months. Similar studies have been performed previously, but typically with a...

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Microbial Control

The Microbial Control team is working on a series of related challenges and driving towards a goal to help all member companies have contamination event free environments as soon as possible. Two detailed areas have been moved forward in the last year, low endotoxin recovery and mold monitoring. Both have been subjects of concern for regulators in recent years and so the group has developed science-based harmonized industry protocols that will...

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