Low Risk Frozen Distribution of Single-Use Bags for Bioprocessing

COLD CHAIN BIOPROCESSING

As global clinical pipelines expand with more complex and temperature-sensitive products, the distribution of high value active pharmaceutical ingredients (API’s) between development sites, clinical sites, and drug manufacturers for further processing will become a more relied upon paradigm. This is the case in the ongoing race to develop treatments for COVID-19, which requires a temperature-controlled distribution network that can quickly scale-up to meet huge demands.

This paper provides guidelines:

  • to employ sensors for monitoring critical shipment parameters
  • on utilization of more suitable low-temperature materials and packaging
  • for qualification and evaluation through simulated standards and testing real-world transit lanes

Implementing these guidelines increases visibility in your distribution lane, incorporates robust materials, and qualifies them against relevant metrics to ensure consistent product quality in cold chain.