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New temperature-sensitive pharmaceuticals pose a problem for logistic providers
Pharmaceutical Commerce has reported that just under half of the new drugs approved by the FDA last year required strict temperature control for storage and transport.
The number of new drugs totalled 57, of which 23 required a standard refrigeration of 2-8°C for storage and transportation.
Pharmaceutical Commerce found that many of the new drugs needed alternative temperatures to remain quality and safety, including pharmaceuticals requiring below-zero or cryogenic temperatures.
One of the drugs approved was Grifols’ Fibrin Sealant which requires storage at -18°C; another (Biomarin’s Brineura) requires a -35°C to -15°C system, and as for the 3 cellular/genetic therapies that were approved: (Spark Therapeutics’ Luxturna (-65°C); Novartis’ Kymriah (-120°C); Kite Pharma’s Yescarta (-150°C).
What should logistics providers do?
It’s clear that this situation proposes a complex problem for logistics and needs to be handled delicately. The first solution would be to seek custom and bespoke care for each drug, ensuring individual temperature requirements are met. This seems simple, but it comes with financial challenges for logistic providers and businesses. There are concerns that storage and transportation costs will skyrocket due to extra care and management.
Statistics from the Biopharma Cold-Chain Sourcebook estimate the global volume of cold chain products are at a healthy $283 billion, and is growing twice the rate of non cold-chain pharmaceutical products.