The Growing Importance of Cold Chain Management in Biopharmaceutical Development

By Russ Hager

Volume 10, Issue 2 (Winter 2011/2012)

As clinical trials become progressively more complex, pharmaceutical and biotech companies face a multitude of logistical challenges. The age of personalized medicine and small-molecule drug development has made it imperative that clinical trial samples reach their destinations safely, securely, and at the right temperatures. The heightened demand is reflected by the fact that transportation and logistics services that can account for as much as 30% of a study budget. This has made managing the biomaterial cold chain a critical component in the research and development of biopharmaceutical products. Cold chain management defines how temperature-sensitive products and biomaterials such as clinical trial samples, cell banks, and active pharmaceutical ingredients are packaged, transported, and stored throughout the research and development process. Any weak link in this chain can compromise sample or product integrity, breach security, delay shipments, and ultimately result in financial loss or liability…

Citation: Hager R. The Growing Importance of Cold Chain Management in Biopharmaceutical Development. BioProcess J, 2011; 10(2): 17-20. https://dx.doi.org/10.12665/J102.Hager

Posted online December 22, 2011