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European Pharmaceutical Contractor
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| With big reputations at stake, Jeff Clark of BioStorage Technologies, Inc and Rolf Lucht of Globex24 reiterate the importance of building biomaterial integrity into the global biopharmaceutical cold chain
The biopharmaceutical cold chain has begun to play an increasingly critical role in global pharmaceutical and biotherapeutic development processes. It defines how temperature-sensitive biological assets are packaged, transported and stored throughout the R&D cycle. When building or evaluating their cold chain processes, drug developers must remain aware of one basic, yet oftenoverlooked principle: the cold chain is the same as any other chain in one key area – it is only as strong as its weakest link.
THE ROLE OF THE COLD CHAIN IN BIOPHARMA DEVELOPMENT
Temperature-sensitive biomaterials (clinical trial samples, cell banks, tissue samples, active pharmaceutical ingredients, and microbiological and viral samples) play a vital role in bringing new drugs to market. At various phases in development these materials must be transported between collection sites, analytical laboratories and biobanking facilities. They must be managed carefully at all times during transit and storage in order to maintain their cold or frozen state and meet regulatory guidelines.
Weakness or failure at any point in the chain can compromise product integrity, breach security, delay shipments and, ultimately, result in financial loss or liability. For example, if clinical trial samples thaw during shipment from collection site to testing lab, the samples might need to be discarded. This could cause financial loss in situations where the sponsor must then rerun the trial. Or, if samples don’t reach their intended destinations on time, testing could be delayed causing a ripple effect throughout the development schedule.
Because one day on the market can generate millions of dollars in revenue, it is in the best interests of the drug developer to build a reliable, efficient cold chain that protects the company’s biological assets and helps bring products to market faster. Additionally, from a regulatory perspective, lack of compliance can delay biologic shipments at inspection points or subject drug developers to financial penalties ranging from hundreds to thousands of dollars. |
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As Executive Director of Operations, Jeff Clark oversees BioStorage Technologies’ day-to-day biomaterials storage, cold chain logistics and sample management functions. He is responsible for ensuring the integrity of clients’ biological materials throughout all phases of shipping, handling, tracking and storage. An expert in international logistics, Jeff has more than two decades of senior-level management experience with leading worldwide transportation and logistics service providers. His expertise has been recognised by both the US Department of Commerce International Division and the Indiana Credit Management Association, who recruited him to teach seminars on US export regulations and compliance, Incoterms 2000 and letter of credit practices. Jeff holds a diploma from the International Air Transport Association (IATA) and International Federation of Freight Forwarders Association (FIATA). He also earned certifications in international rates and tariffs, advanced cargo agent 803-53/01 and IATA hazmat training. Additionally, he is a member of the American Chemical Council – Responsible Care Provider.
Rolf Lucht is Manager of Logistics and Projects for Globex24, a provider of global, integrated cold chain logistic solutions for the pharmaceutical, biotechnology and life science industries. In this role, he is responsible for worldwide logistics, project management and procurement for the company’s client base. Prior to Globex24, Rolf spent 13 years with DHL where he held several positions, most recently managing nationwide key accounts and customer service. At DHL he was also responsible for developing the company’s first client-specific logistics project for the healthcare industry. Earlier in his career, Rolf also held logistics positions in the Formula E racing circuit. |
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