Pharmaceutical Commerce - April 2010 - (Page 18)

SupplyChain | Logistics New Study Sees Double-Digit Growth in Cold-Chain Services for Life Sciences < continued from page 1 Fig. 3. Cold-chain logistics spending will expand from $5.1 billion in 2008 to $6.6 billion by 2011 $7.0 $6.0 $0.9 “Biopharma Cold Chain Sourcebook 2010” surveys growth rates for pharma, biotech, vaccines, blood products and clinical materials, US and international regulatory bodies such as FDA, USP, PDA, IATA, MHRA and others, and air, ground and ocean carrier modes. It includes packaging materials and technologies, refrigeration systems and instrumentation. Regulatory push Traditionally, cold chain procedures have come out of stability testing as pharma companies move their products toward com- the US Pharmacopeia issued a top-to-bottom proposed revision of USP <1079>. Comparable updates and revisions are occurring at Health Canada, the UK’s Medicines and Healthcare Products Regulatory Agency, and European Union good manufacturing practices. The direction of these revisions and updates is exemplified by the summary of the proposed USP <1079>: “Good storage and transportation practices require that organizations involved in the storage and/or transportation of drug products maintain a quality management Rest of world $0.6 $1.0 $1.9 $1.5 $1.5 $5.0 $4.0 $3.0 $2.0 $1.0 $0.0 Asia Europe N. America $2.1 $2.4 2008 2011 Fig. 2. $5 billion was spent on global cold-chain logistics in 2008, in a total biopharma logistics market of $43 billion $3.2 $2.0 Cold chain transport Cold chain packaging Non cold chain transport Non cold chain packaging $9.3 $28.8 mercialization. Most products are expected to be kept in a temperature regime of 2-8°C (36-46°F); some at 2-25°C (36-77°F), and many at “room temperature” (under 25°C). Industry labeling and safety guidance has allowed for a limited amount of excursions above these ranges, but historically the duration of those ranges has been poorly reported. For many refrigerated products, the need to keep it from freezing (0°C) is as important as keeping it below 8°C. Temperature-controlled shipping will grow purely on the basis of increased shipments, but the entire activity is going to get more complicated—and more expensive— as a result of evolving regulations both in the US and worldwide. In 2009, the World Health Organisation began updating its Good Distribution Practices documents; the Parenteral Drug Assn. began a revision of its “Technical Paper #39,” and the International Air Transport Assn. issued new guidance on perishable air cargo. At the same time, the Healthcare Distribution Management Assn. issued a report, “Managing Cold Chain & Temperature Sensitive Products.” In early 2010—outside the scope of the Sourcebook, 18 APRIL 2010 system (QMS) that includes a storage management system (SMS) and transportation management system (TMS). Together, the QMS and its component SMS and TMS help ensure that proper storage and transportation practices are in place from the point of manufacture to the point of end use or administration.” All these “systems” will require additional manpower, data collection and reporting, both from manufacturers and from their shipping and logistics service providers. Logistics service market The Sourcebook estimates total biopharma logistics costs of $43 billion in 2008, of which $5.2 billion, or 12.1%, is devoted to temperature-controlled shipping (Fig. 2). This temperature-controlled segment splits between $3.2 billion for logistics and transport, and $2.0 billion for packaging materials and instrumentation. Cold-chain shipping started out simply with ice-cooler-type containers packed with dry ice, ice or gel packs. Now there are purpose-built superinsulated containers (at roughly $100 per container) that include gel packs with specific temperature ranges that can be “dialed in” by selecting the appropriate freeze-melt points. Package design and component technology has advanced to where a shipment can be kept at temperature (usually, 2-8°C) for two or even three days, in some cases making overnight delivery unnecessary. A comparable evolution is occurring with instrumentation, which is migrating from simple color-coded indicators attached to a container to radio-enabled sensors that can be read remotely. Whereas temperature profile data in the past had simply been a record of high and low temperatures experienced during a shipment, to timestamped measurments along an entire shipment route, with accumulated data being downloaded for recordkeeping procedures to be satisfied. Nearly all insulated containers with refrigerants are defined as “passive” temperature protection; “active” protection, particularly for air cargo, involves batterypowered or plug-in ULDs, heating as well as cooling machinery, and the ability to report data not just at the end of a shipment transit, but even at intermediate points along the way. The active ULDs are equipment that is inherently reusable; reuse or recyclability is now coming to the fore with the passive cartons and gel packs. Some packaging makers have set up automatic-return processes so that the package can be reconditioned and reused; others have made arrangements for recycling through, for example, collecting expanded polystyrene foam and sending it to recycling firms for that material; others have gone the “green” route of using renewable materials. All of these efforts can be claimed by pharrma manufacturers as a way to shrink their carbon footprint. Global movement In line with industry projections of faster growth rates in emerging markets, cold chain activity is rising faster in those markets as well. While North America and Europe will grow by about 19%, Asia is heading for 50% growth, and the rest of the world by 33% (Fig. 3). While much of this represents the same biological products coming into US and European markets, a significant part of the Asia and ROW market will come from vaccination programs which have expanded significantly through philanthropic efforts like the Bill and Melinda Gates Foundation, which announced a $10-billion grant for vaccine development and application over the next decade. While vaccine development and use will expand in coming years, the growth in cold-chain activity will not necessarily be linear with the number of dosages produced; there are efforts to package vaccines more efficiently to expedite their transportation, and to develop roomtemperature versions of some (which could still require temperature control, if not refrigeration). That room-temperature vaccine development raises another factor that could have tremendous influence on the overall temperature-control services market. Some of the latest regulations require temperature management of “controlled room-temperature” (CRT) products—into which a vastly larger cross-section of the pharma industry fits. As study of cold-chain shipping practices has advanced, the realization that CRT products can be subjected to extremely high temperatures (in the trunk of a car or truck, for example) as well as extremely low (in an air shipment traveling without heated storage compartments). While CRT products will not require the elaborate safeguards applied to refrigerated products, they will require some level of insulation, and some level of temperature monitoring, according to the Sourcebook. “Biopharma Cold Chain Sourcebook 2010” is available from Pharmaceutical Commerce at, or by calling 516 869 0334. PC

Table of Contents for the Digital Edition of Pharmaceutical Commerce - April 2010

Pharmaceutical Commerce - April 2010
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Information Technology
Packaging & Drug Delivery
Legal | Regulatory
Executive Training & Development
Editorial Index & Meetings

Pharmaceutical Commerce - April 2010