A CDMO’s customers were increasingly preferring to rely on single-use bags as primary packaging for their products during fluid management and cold chain transport. This allowed for scalability, a storage density increased fourfold, easier handling, larger volumes of up to hundreds of liters, and improved options to work in a closed system without manual handling.
The CDMO’s customers had different suppliers for single-use bags and protective clam shells which were limited to only few available types of single-use bioprocess containers. The CDMO therefore had to build its manufacturing plant based on different scenarios, resulting in inconsistent performance and insufficient product loss rates during cold chain logistics, which covered aspects such as aseptic filling, freezing to -80°C, and international cold chain shipment.
After comparing available solutions to reduce the breakage rates of the frozen and shipped single-use bags the CDMO agreed to conduct trials with a possible solution. Read how the RoSS (Robust Storage and Shipping) shell allowed them to implement robust technologies around the brittle single-use bag and to consequentially reduce product loss.