8 Questions to ask when planning new single-use biomanufacturing capacity

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1. 1Can you achieve a level of process productivity suitable for commercial success?
   
   
2. How long will it take to get the facility built, validated and operational?
   
   
3. What will it really cost?
   
   
4. What will it take to make your single-use process GMP compliant?
   
   
5. How will you integrate robust process control architecture?
   
   
6. Where will you get in-depth process support and training?
   
   
7. How easy will it be to change the process or adapt it for multi-drug production in the future?
   
   
8. What will the FDA and other regulators think about your disposables-based process?

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