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Lori A Ball of BioStorage Technologies sets out the rules for exporting clinical trial samples

As clinical trials become increasingly complex, pharmaceutical and biotech companies face a multitude of logistical challenges. The age of personalised medicine and large-molecule drug development has made it imperative that clinical trial samples reach their destination safely, securely, and at the right temperature. In addition, while blood, urine, microbiological and viral sampling have always been common, samples are increasingly being collected for biomarker research, which also demands strict temperature control to ensure sample stability.

This has made managing the biomaterial cold chain a critical component in the research and development process. Cold chain management defines how temperaturesensitive products and biomaterials, such as clinical trial samples, cell banks and active pharmaceutical ingredients, are packaged, transported and stored throughout the research and development process. Any weak link in this chain can compromise sample or product integrity, breach security, delay shipments and ultimately result in financial loss or liability.

According to industry estimates, logistics can account for 50 per cent of study budgets, especially for trials involving infectious diseases and anti-infectives (1). Therefore, a lack of forward-thinking and comprehensive planning for cold chain management can potentially cost a sponsor millions of dollars. When developing a cold chain strategy, sponsors should consider a few basic rules to help ensure efficiency and compliance.

CHOOSING THE RIGHT COLD CHAIN PARTNERS

With the globalisation of clinical research, the safe, punctual and compliant transport of biomaterials, study drugs and other sensitive materials is becoming increasingly intricate. As a result, many pharma and biotech companies partner with specialised providers who manage the full scope of clinical trial logistics, including aggregating and coordinating the services of multiple couriers and packaging partners. It is essential that logistics personnel are involved early in the drug discovery process to coordinate lines of communication throughout the cold chain. This will ensure that all personnel have upto- date information on the progress of any given clinical trial sample.

Choosing a partner who can reduce product development time cycles, eliminate bottlenecks and provide immediate access to advanced technologies and expertise is a valuable asset. Thus, companies should view the task of establishing cold chain partnerships as a key strategy for a competitive advantage, rather than simply reducing the burden of non-core activities.

By staying ahead of regulations and providing cost-saving measures, such as bundling shipments from multiple incountry sites, logistics providers can help clinical trials run more smoothly, thereby saving the sponsor time and money.

KNOWLEDGE OF INTERNATIONAL REGULATIONS

Each country has its own regulations, codes, policies, procedures and customs that affect international shipments. Therefore, when exporting clinical trial samples, logistics personnel must be cognizant of regulations imposed by government agencies in both the originator and destination countries. Although each country may have different laws, the International Air Transport Association (IATA) publishes industry standards for shipping hazardous materials via air in its annual Dangerous Goods Regulations manual (2). Adhering to these regulations ensures that all dangerous goods are shipped in the safest and fastest method.

For example, shipments from the US to Europe can be made to one country within the EU and can then be freely circulated within the EU, subject to some minor exceptions. Furthermore, all investigational supplies manufactured outside of the EU must be released by a registered Qualified Person (QP) for use in European clinical trials (3).

In the US, the US Customs and Border Protection (CBP) agency has dictated that it is the responsibility of the importing company to ensure that inbound materials meet admissibility requirements and that proper permits are obtained in advance of the goods’ arrival in the US (4).

Additional regulations that must be followed to ensure that temperature-sensitive clinical trial shipments are not delayed at customs, include:

Harmonised Tariff Schedule
All goods that enter the US are categorised according to the harmonised tariff schedule (HTS) issued by the US International Trade Commission, which prescribes the classification of merchandise by type of product and determines how much duty will be collected (5). The importer is responsible for properly classifying the merchandise before it enters the US and ensuring that the HTS number is noted accurately on import documents.

FDA Product Code
Certain shipments also require an FDA product code on import documents. This code represents industry, class, subclass, product and other important details. The Office of Regulatory Affairs offers an online tool for building valid FDA product codes (6).

Customs-Trade Partnership against Terrorism
Participation in the Customs-Trade Partnership Against Terrorism (C-TPAT) offers an additional means to expedite imported cargo shipments entering the US (7). Participating businesses ensure the integrity of their security practices and verify the security guidelines of their supply chain partners. In exchange, they receive reduced inspections and priority processing for CBP inspections and are assigned a specialist who will validate and enhance security throughout the company’s international supply chain.

ADR, RID & ICAO Guidelines
The Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), and the Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID) are European agreements that outline requirements for the international carriage of dangerous goods by road and rail, respectively. The International Civil Aviation Organization (ICAO) provides technical instructions for transport of dangerous materials by air. These regulations identify packaging, labelling, classification and other requirements developed to ensure safety when shipping dangerous goods, such as biological samples and materials (8).

Infractions to these regulations can delay the delivery of time- and temperaturesensitive clinical trial samples and result in costly fines.

THE ROLE OF PROPER LABELS & DOCUMENTATION

Pharmaceutical and biotechnology companies that ship biological or hazardous materials must follow strict standards for labelling and documentation. For instance, a completed dangerous goods declaration form must be attached to Category A infectious substance (for example Bacillus anthracis and Hepatitis B cultures) shipments to avoid shipping delays and the corresponding risks to product integrity. Dry ice, for example, is classified by the Department of Transportation (DOT) and IATA as a miscellaneous hazard, class 9 material (2,10). As a result, specific procedures must be followed when packaging and shipping materials with dry ice.

In-transit storage conditions, as well as warning statements or content identifications, should be stated legibly on the label. Labels must also state clearly that the materials inside are to be transferred to a specified storage temperature immediately upon receipt.

CONCLUSION

Once a back office function, logistics now plays a critical role in the clinical research process. It requires not only an in-depth understanding of shipping and storage, but demands adherence to compliant processes and constant awareness of changing regulatory guidelines. Choosing the right logistical service partner to oversee the global transportation of clinical trial samples is becoming a necessary component to a successful research study. Such alliances also enable sponsors to have immediate access to technological innovations and cold chain expertise, thereby resulting in cost and time-savings, as well as favourable quality protection.

References

  1. Quinn FJ, Time is Money in Clinical Logistics, Pharmaceutical Commerce, 30 March 2006, http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=260, accessed 12 April 2010
  2. International Air Transport Association, Dangerous Goods Regulations, 51st Edition, 2010
  3. Frank L, Gourley D et al, Global Supply Chain Management, Applied Clinical Trials, 1 June 2009, http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Rotating+Feature+Article/Global-Supply-ChainManagement/ArticleStandard/Article/detail/602049, accessed 13 April 2010
  4. US Customs and Border Protection, US Import Requirements, http://www.cbp.gov/, 13 April 2010
  5. US Customs and Border Protection, Duty, Tariff Rates, http://www.cbp.gov/xp/cgov/trade/trade_programs/duty_rates/, accessed 13 April 2010
  6. Office of Regulatory Affairs, Product Code Builder, http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.htm, accessed 13 April 2010
  7. US Customs and Border Protection, Customs-Trade Partnership Against Terrorism (C-TPAT): Securing the Global Supply Chain, http://www.cbp.gov/xp/cgov/trade/cargo_security/ctpat/what_ctpat/, accessed 13 April 2010
  8. United Nations Economic Commission for Europe: http://www.unece.org/trans/danger/what.htm, accessed 14 April 2010
  9. Office of Environmental Health & Safety, Shipping Dangerous Goods: University Guidelines, 7 March 2010
  10. Department of Transportation, Research and Special Programs Administration, 49 CFR Chapter I. Hazardous Materials Transportation; Advisory Guidance; Offering, Accepting, and Transporting Hazardous Materials

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Lori A Ball is the Senior Vice President of Global Operations at BioStorage Technologies. Lori leads all global operations, including logistics, sample handling and processing and information technology, in addition to sales and marketing initiatives for the company. Lori earned a BA in Education from Anderson University, Indiana and an MBA from Indiana Wesleyan University. She holds Six Sigma Green Belt credentials and has completed Six Sigma Executive and Champion training.
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