Patient safety and regulatory compliance are the key drivers within cold chain logistical systems. Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.
Preventing patients from receiving “counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the U.S. Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than that for traditional pharmaceuticals, and the requirements for documentation vary as well.
Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. This article reviews two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.
This infographic offers insight into the 10 most important things to consider when shipping high-value biologics in dry shippers. Learn about data loggers, temperature holds, orientation, shipping racks, and much more.