Cell therapy companies often inadvertently compromise commercial success because they fail to adequately explore or embrace alternative manufacturing technologies.  The reasons are varied including:

  • The possibility that existing clinical data will be put at risk by making a process change
  • Clinical trials are already defined or approved based on the existing process
  • The cost, quality and operational difficulties associated with scaling up the current process are not understood
  • They are unaware of alternative technologies or technologies are simply not available
  • There are more urgent priorities for staff and precious capital

However, with an experienced cross-functional team and careful planning, an appropriate scale-up strategy can be created, regardless of where you are in your clinical trials.

 

Ask us how.

 

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