Maria Toutoudaki/Selahattin BAYRAM/Getty Images; Dan Ward
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Pharmaceutical manufacturers devote considerable time and resources to implement effective cold-chain practices that protect
products, especially sensitive biopharmaceuticals, blood products, and vaccines, from damage. Although efforts have traditionally
focused on refrigerated (2–8 °C) and frozen (-20 °C) products, there is growing attention to controlled room temperature (CRT)
products, which require maintenance at 15–25 °C to ensure quality and efficacy.
The emphasis on CRT shipments, expanding volumes of biologics, and rising demand from emerging markets are spurring strong
growth for goods and services related to temperature-controlled logistics, particularly in Asia and the southern hemisphere.
According to the 2012 Biopharma Cold Chain Sourcebook, published by Pharmaceutical Commerce, cold-chain logistics spending is forecast to grow approximately 12% from $6.5 billion
in 2010 to $7.6 billion in 2013 and increase another 12.6% to reach $8.9 billion in 2016. Packaging, including instrumentation,
accounts for about 37% of the dollars spent on cold-chain logistics. The focus on CRT shipments is particularly strong in
Canada, Israel, Ireland, the European Union, Turkey, Saudi Arabia, and South Korea, according to Prakash Mahesh, vice-president
of marketing and business development at Sonoco Protective Solutions, ThermoSafe Brands, formerly part of Tegrant.
Evolving global regulations
Regulations involving the cold chain are undergoing change. "South America, Mexico, South Africa, Saudi Arabia, and others
are enforcing strict label claims," says Mahesh. In fact, he says, the European Medicines Agency (EMA) is pushing toward strict
label claims and "will likely require 'proof' of protection come 2013."
With evolving regulations worldwide and dramatic growth in the number of temperature-sensitive products, it's more essential
than ever to manage conditions in storage and transit. "Late-phase clinical development teams understand the need to maintain
strict temperature adherence to ensure the positive outcomes in their trials as well as maintaining patient safety," says
Andrew J. Mills, CEO of Americas for Intelsius, a DGP company and supplier of temperature-controlled packaging. He explains
that some of the drugs coming on the market "can become toxic if frozen...or lose efficacy very quickly if warmed."
In addition, he says, "The increased FDA/EMA collaboration in overseas inspections is making the need for good cold-chain
practices felt all over the globe." He explains, this regulatory attention is not only encouraging adoption of good cold-chain
practices from new sectors of the marketplace, but also "bringing emerging markets up to speed with good distribution practices
(GDP) compliance faster."
An e-pedigree law, scheduled to go into effect on Jan. 1, 2015 in California, is encouraging drug makers to adopt technologies
that will implement traceability and cold-chain management simultaneously. A number of organizations offer resources to help
companies follow GDP, including the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) (1). For links
to these resources, see the online version of this article at
http://www.PharmTech.com/coldchain/.
