How To Achieve Scalable Freezing & Thawing Of Biopharmaceuticals

What’s Scalability?

Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios. Single Use Support fulfils this requirement by standardizing the IFGS – icefront growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether LabScale, MidScale or LargeScale.

Setup for controlled icefront growth speed

RoSS.pFTU is a plate-based freeze-thaw platform and specially designed for RoSS. RoSS is a secondary packaging to protect single use bags of any sizes and any manufacturers, such as PALL, Thermo Fisher, Cytiva, Sartorius, etc.

In this application note the aim is to adjust the characteristics of the machines via settings, parameterizations, etc. to achieve reproducible, controlled and scalable freeze runs.