The customer, a global Contract Manufacturing Organization (CMO) with a global total turnover of > 5 billion USD, produces different drug substances (BDS) of highly valuables mABs in batch sizes from 10l to 700l for clinical phases up to commercialized products. The BDS is frozen < -85°C (-121°F) and shipped within Europe or transatlantic for max. 200 hours with dry ice and stored. At the fill & finish site, the BDS is thawed for producing the drug product.
Due to several advantages of single-use bags like filling in closed system, higher volumes, scalability and high storage density more and more customers of the CMO wants to bulk fill into bags. But the biggest challenge of single use bags was the high loss rate of 0,5% to 5% due to their sensitivity at sub-zero temperatures. The product loss rate depends on the bag used, the clam shell of the product, the process and the shipper/shipping route. Therefore, the goal was to significantly reduce the current product loss
Continue reading to learn how they set up a cold chain process and implemented robust technologies around the brittle single use bag and to consequentially reduce product loss.