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Case Study: Transporting critical bulk drug substance from China under Controlled Room Temperature

A biopharmaceutical company specializing in gene knockout technology for drug discovery needed to transport a bulk drug substance under Controlled Room Temperature (CRT) conditions from their shipper in Shanghai, China to a clinical packaging company in Pennsylvania, USA. There were to be a number of shipments over time, and each shipment was for a different quantity of the drug substance. 

While the shipper in Shanghai had the facility to manage the shipments, they did not have the resources to assist our client with securing the appropriate packaging. The ideal configuration would transport drums of biopharmaceuticals and have proper controls in place to monitor the tight 15
° to 25°C temperature requirements. Beyond the physical packaging, the client also needed a transportation partner with experience in managing global export and import requirements (especially in China), as well as the knowledge to recommend the best route for the fastest possible delivery with minimal delays.

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Challenge


To secure appropriate packaging and transport a bulk drug substance of a critical nature and value from Shanghai, China to Pennsylvania, USA maintaining Controlled Temperature conditions.

QuickSTAT's Solution


1. Procured pre-qualified packaging systems 

With a team of experts, QuickSTAT began sourcing the packaging system only to discover there were no suitable solutions in China. Using its global network, QuickSTAT quickly found three pre-qualified 120-hour CRT pallet shippers in the US that could accommodate the various payload sizes anticipated and maintain temperature within normal clearing times. In addition, the manufacturer provided 3D drawings to illustrate how the drums should fit into the packaging configuration, an extra step that saved valuable time on the front end for the client.

2. Planned end-to-end logistics details

After the pallet shippers were sent to QuickSTAT's Shanghai facility, where they were stored until needed by the shipper, QuickSTAT worked closely with the client and shipper to set shipping dates, allowing for pre-conditioning of the packaging systems per manufacturer specifications to establish CRT before delivering the pallets. This advance planning allowed for the shipment to be loaded into the packaging system immediately and have it ready for transport quickly. 

3. Ensured proper temperature throughout transit

To monitor temperatures throughout transit, four Sensitech TT4 TMDs were positioned in various areas with the payload for maximum accuracy.

4. Selected strategic routing

There were two potential choices for airline and routing. The first was a standard carrier that would fly into Newark, NJ. The second flew to Philadelphia, PA (closer to the ultimate destination) and had CRT storage facilities available at the airport in case of customs or FDA delays. While the second was a more expensive option, our client chose quality assurances over cost.

5. Managed global export and import requirements

Regulations in China change quickly and companies need transportation partners that are well versed in the global regulatory landscape. Prior to pick up from the shipper, QuickSTAT worked with the client's designated customs broker in the US to ensure that all export and import documentation was in place and accurate. 

6. Established communication protocols

Communications protocols were established between the customs broker and QuickSTAT's team in New York to ensure there were no disruptions during the shipping process. Using QuickOnlineRx, QuickSTAT's online shipping portal, our client was able to transmit all customs documentation electronically, track the status of each shipment and receive proof of delivery notifications in real-time.

Results


This customized solution delivered great results for the client. All shipments stayed in temperature range, even during a few customs delays, and the integrity of the product was maintained.

Summary


What made the difference in this particular case was QuickSTAT's personalized attention and willingness to act as a liaison between all parties. Shipments went smoothly in large part because of the significant amount of communication that took place between QuickSTAT, the client, the shipper and the customs broker. This was combined with diligent attention to detail where export documentation was concerned. While important in all clinical trial logistics situations, it's especially critical when shipping from China where regulations are fluid and often amended.




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