*Blog post provided by Thermo Fisher Scientific *
Introduction to our Cell Therapy e-books
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.
Thermo Fisher Scientific will be exhibiting at this year’s World Stem Cells & Regenerative Medicine Congress 2016 taking place this 18-20 May at the Business Design Centre, London.