Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: regulatory and scientific challenges for comparability
Manufacturing of more-than-minimally manipulated autologous cell therapies presents a number of unique challenges driven by complex supply logistics and the need to scale out production to multiple manufacturing sites or near the patient within hospital settings. The existing regulatory structure in...
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| Main Authors: | , , , |
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| Format: | Default Article |
| Published: |
2014
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| Subjects: | |
| Online Access: | https://hdl.handle.net/2134/16214 |
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