Decentralized Manufacture – Full SpotlightPublished: October 24, 2019
GUEST EDITOR: Dr Nicholas Medcalf, Head of Advanced Therapies and Enabling Programmes, Ageing Society, Health and Nutrition Directorate, UK Research and Innovation
Does decentralized manufacturing represent the future for commercial autologous cell & gene therapy products, and if so, where will it sit on a spectrum that stretches from regional facilities to the patient’s bedside itself? The potential benefits are manifold, but imposing challenges remain – not least the issue of regulatory oversight and QC the closer one gets to the point of care. However, the will and, increasingly, the technological solutions are emerging to make this a reality.
- Making the business case for decentralized manufacturing
- The role of automation in enabling local and point of care bioprocessing
- Defining fit-for-purpose regulatory compliance models
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