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PUPSIT – An update on BioPhorum/PDA work to develop a risk-based position

Do you need to commit to a pre-use post-sterilization integrity test (PUPSIT) strategy? Is it a control needed for your product? If so, what is the best way to implement it?

These are questions that have been challenging operations and their filtration experts since the inclusion of PUSPIT in Annex 1. Finding the correct answers has become increasingly significant with the ongoing debate about the wording and interpretation in the current Annex 1 redraft.

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Biomanufacturing technology roadmap: 6. In-line monitoring and real time release

This chapter of the First edition Biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and adoption of effective in-line monitoring and real-time release capabilities. To help the industry achieve this future state it describes the scenarios considered, the future needs, challenges and potential solutions as well as the linkages and dependencies on other parts of the roadmap. It considers the contribution that disruptive and emerging technologies can play and regulatory considerations before finalizing with conclusions and recommendations.

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