APP NOTE: "BESTCELLERS": CONTROLLED FILLING & FREEZING OF CELLS

SCHOTT Pharma AG & Co. KGaA and Single Use Support GmbH are joining forces to extensively test SCHOTT Pharma’s innovative solutions for the safe and efficient handling of small volumes of pharmaceuticals at ultra-low temperatures.

Automated filling systems are recommended by many market experts to reach the next level in drug substance management.

Being able to control the freezing behavior of bulk drug substance is the ultimate goal in Biopharma manufacturing.

As one of the most essential parameters in terms of achieving control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. The leverage of the ice front growth speed had a significant impact on controllability and, as a result, on the protein quality.

A global biotechnology company produces different drug substances of highly valuables monoclonal antibodies (mABs). The company experienced a product loss rate between 0,5% and 5% due to the sensitivity of single-use bioprocess containers at sub-zero temperatures. Therefore, the goal was to reduce the current product loss below 0.5%.

This case study discloses how the implementation of RoSS® technologies from Single Use Support had an impact on the product loss during trials of hundreds of single-use bags. 

You will be surprised of the cost savings due to reduced product loss.