The evolving demands of the temperature-controlled supply chain for cell and gene therapy
As drugs have become more complex, so too has the supply chain, which must innovate to accommodate the necessary, specialized conditions for the storage and transportation of these drugs, even under extenuating circumstances. As the pharmaceutical industry shifts its attention to biologics and cell and gene therapies, the need for more advanced storage solutions has heightened considerably.
In January 2019, former commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb, M.D. issued a statement regarding the impending cell and gene therapy boom, which began in earnest this year. Citing an increase in the amount of cell and gene therapy-based investigational drug approval (IND) applications landing at the agency, it is clear that this trend will only continue to grow.1 By 2020, the FDA anticipates reviewing more than 200 IND approvals annually, which will add considerably to the 800 active cell-based or directly administered gene therapy INDs currently on file. Based on these figures, 10–20 cell and gene therapies are anticipated to be approved every year.
Source: BioPharma Dive