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New treatments for the cold chain [Integrator]


To deal with a business environment that is changing at a feverish pace, the life sciences and healthcare sector is looking at new opportunities for temperature control.

When German drug manufacturer Bayer patented Aspirin in 1900, it would have struggled to comprehend the reach of the drug in the 21st century. Shelved early in production due to fears of side effects, then dogged by patent disputes, Aspirin has emerged as a global superdrug. Today, consumption of Aspirin and its generics amounts to more than 120 billion tablets a year, distributed by global supply chains under strict regulatory controls.

And Aspirin is, of course, only one of many products in the life sciences and healthcare (LSH) sector, which today is continually facing significant and specific challenges to its business and therefore also its supply chain. The patent cliff, where big pharma companies are seeing patents expire on some of their best-selling drugs, will open up new generic drug manufacture. This will have a major impact on the industry. As Maura Musciacco, Senior Analyst at Datamonitor Healthcare reports, these changes have sparked "a high degree of concern for branded pharma, given that this loss in sales will almost offset the net positive growth."

In addition, changing demographics and the global economy are both affecting the demand for drugs and LSH products. For example, an emerging middle class means India is growing as a consumer of LSH goods, and is now in the top ten countries of healthcare spend per capita. Research and development of new drugs for conditions such as diabetes, cancer, and Alzheimer's are fueling change, too, since an aging global population is susceptible to such illnesses.

Regulating temperature
Just as significant as these changes in the LSH sector is the challenge of a growing reliance on the cold chain and on managing temperatures throughout the logistics cycle. Changes in drug composition - products having larger molecular structures or being biotech-engineered - make them more susceptible to temperature and humidity. Regulatory requirements worldwide put more and more emphasis on temperature control compliance and monitoring. Pressure is increasing to ensure "ship to label", where regulatory authorities require proof that products have not only been stored at the temperature stated on the label, but also kept within a temperature range during transportation.

It is more and more challenging for pharmaceutical companies to transport such products economically. Products that now require "controlled room temperature" (CRT), or the broad range control, may formerly have shipped as general cargo, since the products were deemed to be very stable. New regulation is demanding new handling practices.

Meeting end-to-end cold chain demands
Establishing temperature control and compliance at every stage of the transportation cycle beyond the warehouse is vital. In a recent report, Steve Todd, Senior Good Distribution Practice (GDP) Inspector for the U.K.'s medical regulatory body MHRA, outlined the importance of complete awareness during the whole journey of a product. "The transportation arrangements from one location to another should be regarded as an extension of the storage activities, and distributors are expected to treat each journey as unique, with the length and complexity, as well as any seasonal variations, being considered when choosing the packing method and mode of distribution."

The new trend of temperature mapping
Fulfilling this requirement involves a thorough analysis of all transportation modes, and an assessment of whether further temperature control management is necessary. Temperature profiling or mapping is a growing trend whereby companies assess each link of the supply chain journey for temperature control. The data amassed en route during the research, carried out over a year to allow for seasonal variations, can be used for solutions such as developing unique thermal packaging, or learning the specific location in an aircraft's hold that will maintain the required temperature during flight.

This process can inform how to handle the shipment. But there is also an increasing demand to track the shipment at every stage with built-in temperature monitoring. This can be achieved by RFID sensors embedded in packaging that upload information to a web portal at checkpoints along the way. The information can let logistics providers and manufacturers identify changes in temperature, light exposure, and vibration.

For an even sharper picture, some logistics providers, such as DHL, are looking at real-time tracking via cellular mobile and GPS communications. This, however, involves a complicated approval process. Laura Ackermann, VP, Global Head Life Sciences Network & Operations Air Freight, who is supervising the operational launch of DHL's new temperature-control product THERMONET, has ambitions to acquire this holy grail of cold chain management. "We are looking at various options for real-time tracking," she says. "But the biggest challenge is that, just like cellphones, this type of device does need to be turned off during flight. The challenge is that we need approvals airline by airline. There are a few devices that do have approvals for various airlines, but it's not an across-the-board product offering at the moment. But it's certainly where I see the industry going."

Whether the data is relayed in real time or uploaded at regular intervals, temperature checks can be performed at two levels. Ambient temperature - a reading of the environment outside the packaging - is taken by conventional sensors, while near-product temperatures can be established by inserting a probe into the outer packaging.

All this requires a logistics services provider with a powerful network and both the finances and the will to make a strategic investment in LSH supply chains. Logistics companies are striving to offer the perfect delivery conditions for LSH producers in a rapidly changing environment. Only a few, however, are able to comprehensively deliver what is required.

Building an lsh-specific infrastructure
In making sure its warehouses and supply chain were set to comply with LSH Good Distribution Practice, DHL has led the way. Angelos Orfanos, DHL Global Head Life Sciences & Healthcare, emphasizes how the company built its future LSH plan on globalization. "We took globalization as a key element of how we prepare ourselves for the future. That means resources, infrastructure, processes, and of course highly trained and sector-competent people. We need to be ahead of the curve, anticipating changes in the market. So if a customer says, I want to sell into Korea and I need to move my pharmaceuticals under specialized handling conditions, we need to have that in place."

DHL has built an LSH-specific infrastructure that is scalable to evolving global demands. Its LSH network includes 102 life sciences grade warehouses and 24 clinical depots, four regional hubs, and more than 30 life sciences competence centers strategically positioned around the world and specifically designed to meet cold chain requirements. It recently added a $46-million, 19,000-square-meter, custom-built facility to its portfolio in Sydney. The new depot has over 3,000 square meters of dedicated temperature-controlled space.

To cope with the end-to-end requirements, the company is this year making a bigger investment in launching its new product THERMONET. This will create a new standard in the handling of air-freight transportation of temperature-controlled goods, says Orfanos.

Integral to the development of THERMONET was DHL Global Forwarding's acquisition of LifeConEx, which became an additional key component in its temperature-control capability. LifeConEx was formerly a joint venture between the logistics company and Lufthansa, and focused exclusively on temperature-controlled pharmaceutical and LSH products. Now aspects of the LifeConEx IT system named LifeTrack, designed specifically for LSH use and with compliance firmly in mind, are being integrated into DHL's network. This has afforded a whole new level of visibility specific to LSH and temperature-control management of air-freight shipments.

Wherever the shipment is going, visibility, compliance, care, and control are vital. The emerging importance of cold chain and temperature management shows how much has changed in the distribution of medical products - even for a drug as commonplace as Aspirin.

Posted at 23:31

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