The Importance of Integrity

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.