Orange may be the new black, but cold is fast becoming the new normal for the biopharma industry. Thanks to the explosive growth of biologics, by 2020 more than half of our bestselling drugs will be cold-chain products, according to Pharmaceutical Commerce Magazine.1
And while biologics have been a resounding commercial success story for the industry, products that require cold storage – vaccines and therapies, including an escalating number of biosimilars – are raising the logistical stakes for supplying trials.
Consider, for example, that a vaccine shipment originating from the Fisher Clinical Services facility in Basel, Switzerland will experience temperatures ranging from 4ᐤC to 25ᐤC (39ᐤF to 77ᐤF) during its 24- to 48-hour journey to a destination such as Pretoria, South Africa. Temperature fluctuations are as much of a risk for shipments of biologics bound for different parts of the same continent or country as they are for another hemisphere. Consider Europe, which experienced the wrath of heatwave Lucifer during the month of August! In the United States, temperatures in cities such as Boston, Phoenix, Chicago, San Diego and Seattle vary enormously in a single day.
That’s why meticulous packaging and constant temperature monitoring are necessary to maintain cold chain product integrity. Failure can be costly, since a single broken link can waste a sponsor’s precious time and resources, and potentially put the safety of study patients – our first priority – in jeopardy. As Global Cold Chain Technology Lead at Fisher Clinical Services, it’s my job to prevent that from happening – and I’m proud of our track record. Last year alone, more than half of Fisher Clinical Services’ shipments were cold-chain.
Our success is based upon a proven model we developed for creating a robust cold supply chain. Ideally, planning begins 6-12 months before patient enrollment with a thorough understanding of the protocol and what the sponsor wants to achieve. Then we craft a customized distribution strategy that addresses every imaginable issue, factoring in a host of considerations. Among them: The number and location of facilities, depots and sub-depots; the quantity and availability of investigational product; temperature, customs and importation requirements; even the proposed kit size and how convenient it would be for clinical sites to store.
With that knowledge in hand, we move on to shipping considerations for maintaining cold chain, including selection of containers and temperature monitors, adherence to regulatory standards, and commissioning specialized providers as necessary.
Of course, that’s a thumbnail sketch. To learn more about our model, I invite you to download Parts 1 and 2 of the Fisher Clinical Services eBook series entitled “Considerations for Cold Chain Shipment of Clinical Supplies.”These eBook provides greater detail, including a deep dive into passive shipping options, how they work, and the advantages and disadvantages of each.
You’re always welcome to contact me directly at Royce.firstname.lastname@example.org. I’d be pleased to answer your questions about how we engage our expertise and experience to prevent cold supply chains from unraveling.
1) “2015 Biopharma cold-chain forecast.” Pharmaceuticalcommerce.com. Pharmaceutical Commerce. 19 December 2016. http://pharmaceuticalcommerce.com/special-report/the-2015-biopharma-cold-chain-landscape/