You can now download Fisher BioServices' eBook "Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield".
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 the eBook to find out more about:
- Adverse temperature events
- Packaging and distribution
- Clinical site limitations
- Patient administration
- Establishing a chain of custody