CryoPort Inc (CYRX)

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Why The Frozen Cold Chain Market is Heating Up

Posted on Wed, Mar 23, 2011 - 2nd Cryoport Blog

Globalization
This week we received the announcement from the Drug Information Association (DIA) regarding the 2011 DIA Annual Meeting to be held in Chicago in June. The first point made in their description of the 2011 meeting is:

¦Bring together industry professionals, clinicians, patient representatives, and regulatory agencies from all continents
Here we’ve added the emphasis on “all continents” because it is illustrative of the dynamic that is pervading the Life Sciences industry, especially the biotechs, CRO’s and pharmaceutical companies. In the past decade we have seen tremendous growth in the number of interational clinical studies being undertaken with multi-national components to the sample collection. Pharmaceutical Commerce Magazine recently reported cold chain growth in the US and EU at 19%, Asia at 50% and rest of world at 33%. Since the turn of the century we have seen a blossoming of the CRO industry in Southeast Asia and South America as clinical study sponsors have sought to keep trial costs in check and expand their reach to appropriate and representative populations and increase diversity. As more and more of the trials involve biological therapeutic components, the need for stringent temperature control in the clinical trials supply chain – aka cold chain shipping – has become ever more important.

In a 2009 Business Insights Report entitled Emerging Clinical Trial Locations – Eastern Europe they wrote:

The failure of the cold chain distribution process as a result of adverse temperature changes during the storage, handling, or distribution causes a number of serious problems:

¦The patient could be administered an unsafe product;
¦A lack of compliance with global regulatory and standards-based requirements can increase liability;
¦Thermal variability can lead to inconsistency of results between and within batches;
¦The shipment can be rejected by the quality department therefore leading to costly delays – increasing the complexity of trial management.
But the Biopharmaceutical frozen cold chain is not impacted just by the supply of the biologic to the patients enrolled in the clinical trial. The last decade has also brought an expansion of the kinds of testing being conducted in clinical studies for many therapeutic targets. A 2010 Nature Review article (June Vol. 9, pg. 435-450) showed that during the period of 2004 – 2008 there were 35 Voluntary Exploratory Data Submissions (VXDS) shared with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) with genomic data. These studies are geared towards identifying the potential of genetic and genomic data as possible pharmacodynamic, prognostic, or predictive biomarkers. Such testing, however, necessitates the specimens be sent to more specialized molecular laboratories. As patient populations get stratified, the value of each sample becomes more important in order to achieve the numbers needed for statistical significance in a clinical study. Clearly, the frozen cold chain market is heating up as more biomaterials are being transported around the world and more temperature sensitive critical samples are being sent to centralized labs.

Regulation
A second factor impacting the biopharmaceutical frozen cold chain is the changing regulatory environment. A quick Google search on “dry ice restrictions” shows the number of airlines, couriers and countries putting increasing restrictions on the use of dry ice as a refrigerant. Many carriers clearly document their policies of no re-icing, and one can only surmise that this is being driven by a combination of cost and liability. These pressures are also happening at a time when pharma clients report that the FDA is starting to ask them to provide certifications of who and how the sample was re-iced. Many expect this kind of scrutiny on the clinical study cold chain is only going to grow.

The need for improved supply chain management in frozen shipping within the biopharmaceutical market is clearly heating up as the use of dry ice in a global marketplace has begun to show its limitations. To improve the integrity and reduce the risk associated with global frozen shipping, new solutions must be developed such as using dry vapor liquid nitrogen shippers with highly integrated tracking and management systems.

Link

http://info.cryoport.com/biological-shipping-blog