It is the most crucial question in bulk drug substance management: How can product loss can be avoided or at least decreased?
A global Contract Manufacturing Organization (CMO) produces different drug substances of highly valuables mABs. At the fill & finish site, the BDS is thawed. The customer compared available solutions to reduce the breakage rates of the frozen and shipped single-use bags.
But the CMO experienced a high loss rate of 0,5% to 5% due to their sensitivity at sub-zero temperatures. Therefore, the goal was to significantly reduce the current product loss.
The case study discloses how the implementation of Single Use Support products had an impact on the risk of product loss caused by bag breakages and how the most crucial question could be answered.