Phorum

Drug Substance

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 smaller or partial data set and crucially without biomanufacturer involvement.

 

The outcome of this data-driven review process is that the BioPhorum biomanufacturer members have chosen to remove two solvents (NaCl and PS80) as well as revise the requirements for testing at time point zero and for elemental impurities. The team is busy writing up these changes and aims to publish in Q1 2020. As a second step, the team has also looked at the requirements for testing on different types of components and increased granularity will be created. These recommendations are still being finalized but should also reduce the extractables testing required by the industry.

Overall, the team believes that these changes do not represent any erosion of the high standards for patient safety, but instead provide a data-based rationale for where testing is and is not adding value but adding time and cost. Streamlined extractables testing will allow biomanufacturers and supply partners to focus resource where it is most valuable, ultimately supporting industry innovation.

If you are currently in the process of planning an extractables study, please contact your BioPhorum team member or register your interest here :

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