Evaluating the impact of vendor initiated raw material changes are a key activity for ensuring a biopharmaceutical manufacturing process maintains a state of control in response to these changes. The evaluation of an alternative virus filtration post-use flush solution (0.25 M NaOH, 1% SDS) for a monoclonal antibody (mAb) manufacturing process is used as a case study to describe this process.  Triton X-100 is currently used in this manufacturing process to flush the filters after product filtration to remove any residual proteins and other foulants, and prepare the filters for a post-use filter integrity test. After 2021, triton X-100 will no longer be permitted for use in the EU due to environmental impact and an alternative post-use flush solution will have to be used.  To supplement filter vendor studies supporting the use of an alternative flush solution, small-scale virus filtration runs were executed and a product specific assessment of the alternative flush solution was performed. The results of the integrity test after product filtration were compared and enhanced the understanding of the impact of the post-use flush on the integrity test outcome and demonstrated the acceptability of the alternative post-use flush solution for a range of virus filtration operating conditions. Evaluation of the post-use flush conditions at the small-scale supported the manufacturing change control and will ensure continued supply in response to raw material changes.<br/>

Case study in raw material change control: Evaluating an alternative virus filtration post use pre-integrity testing flush solution for a monoclonal antibody manufacturing process

ACS Fall 2020 Virtual Meeting

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