As blockbuster patents expire, drug developers are working to decrease the risk of drug development and lower development costs which Tufts University Center for the Study of Drug Development’s estimates is around $1.3 billion. One strategy is to conduct more clinical trials internationally, which comes with new logistics challenges and strategies.
Some leading challenges and how CryoPort helps companies overcome them include:
1. Viability in transport
A paper published in the proceedings of the 6th World Congress of Biomechanics (2010) indicates that only 0.1% of the cells obtained from an established cell bank kept at 2-8°C and packaged for immediate use, actually survived after 24 hours at that temperature and after vibrations simulating transportation. As Cryoport recently heard in a meeting with top clinical trial professionals, sample and cell viability in transport is the one area that is not easy to control. It is also mission critical as it can be the difference between a drug continuing on in trials or being scrapped.
CryoPort’s innovative liquid nitrogen dry vapor shipper virtually eliminates loss of viability of samples and cells by keeping the temperature a stable -150°C for 10 days. CryoPort’s shock-absorbing package also reduces cell membrane-disruptive vibrations, delivering cells in the same condition as when they were placed in the shipper. Read more about our innovative shipper design.
2. Chain of condition
For trials, it is essentials that materials not only stay at a stable temperature but also that there is record of that stability for later reference. Similar to a chain of custody where we record who has a shipment at any given moment, Cryoport provides a chain of condition so scientists can ensure that their samples and cells were in fact maintained in a frozen state the entire cold chain from the clinic to the laboratory for testing.
There is a growing concern over the counterfeit market, especially with this week's news of Roche's Avastin having counterfeit concerns. Forbes reports, "in developing regions like Asia and Latin America, counterfeits are a growing concern, as many as 30 percent of the drugs sold there are fake and in India, that number is 20% according to the World Health Organization" (Forbes, 2012). Diverting shipments is one method counterfeiters use to get the goods regardless of the stage of development. By monitoring and documenting the temperature inside the dewar, CryoPort knows when and where a package was opened, and for how long, so shippers can detect and act on any security breaches in each shipment. Read more about temperature monitoring here.
4. Clearing Customs
For a clinical trial, it is essential that materials clear customs in a timely manner. In addition to having more “breathing room” with a 10 day holding time, CryoPort also works head of time with teams to ensure that the correct documentation and descriptions are on every package. If a package is delayed, CryoPort can work with our shipping partners to get it cleared, even walking it through customs, if necessary. For more about our logistics services, click here.
5. Resource Optimization
Clinical trials have been hamstrung with 3 or 4 day weeks because of concern over shipping on weekends with dry ice. Because CryoPort’s dry vapor shipper maintains -150°C for at least 10 days, packages can ship over weekends or holidays safely, without re-icing, and therefore maximize their investment in analytic labs and personnel as well as add days to sample collection. Now patients can be taken 5 days a week, adding 25% or more to the trial throughput and significant cost savings.
To learn more about strategies to improve your clinical trials logistics, contact CryoPort.