Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield.

By Dan H. O'Donnell
Associate Director, Cell Therapy Logistics
Fisher BioServices 

If you have a cell-based therapy in development, then you need to consider such variables as packaging, storage, inventory management, monitoring systems, distribution, and even clinical site capabilities well before you begin to prepare the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA).  By sidestepping these issues until clinical trials begin, you may discover late in the game that you have inadvertently limited your product’s scalability and commercial viability, incurred unnecessary costs and complications downstream, and failed to meet FDA criteria for documentation of cold chain and chain of custody requirements. 

Download this eBook to learn more about:

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  • 5 key landmines to cell therapy clinical and commercial development 
  • How to navigate around these landmines in ultra cold chain management of cell therapies
  • Additional resources for your cell therapy research, clinical, and commercial development

 



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