VALIDATED COLD CHAIN LOGISTICS
FOR ANY TEMPERATURE RANGE
Medical treatments are becoming more complex involving human cells and genetically manipulated human cells. The results of these treatments have been truly amazing, dramatically restoring functions to the patient’s body that have been absent since birth. Developments in Cell & Gene Therapy (CGT) are happening so quickly that the technology to support cold chain logistics is desperately trying to keep up with extraordinary user requirements. CGT shipments require highly intricate timing, absolute compliance, and dedicated personnel performance above and beyond the call of duty.
In the EU the donation, procurement and testing of Tissues and Cells are covered by Directive 2004/23/EC, whereas the processing, preservation, storage and distribution are regulated by other Community legislation e.g. The ATMP Regulation. The further manufacturing steps are covered by Directive 2001/83/EC relating to medicinal products for human use.