Luina Bio offers significant expertise in establishing and maintaining cGMP cell banks with our cell bank manufacturing services.
A suitable and stable master cell bank is crucial to product development and supports all phases of the product life cycle from clinical testing to manufacturing.
We operate and maintain a self-contained cell banking suite for the manufacture of microbial master cell banks and working cell banks. For optimal drug production, cells must be passaged as few times as possible. Additionally, the original clone cannot be lost or altered. The master cell banks at Luina Bio are cryopreserved to prevent genetic variation and contamination. Working cell banks are produced from the master cell bank to support the later stages of therapeutic development and manufacturing or cell-based assays.
Our facilities operate according to TGA guidelines and offer both aerobic and anaerobic conditions. We offer in-house release and cell bank stability testing of cell banks and short- and long-term storage in qualified freezers under continuous temperature monitoring. Luina Bio manages automated monitoring of ambient conditions and facilities with a secure quarantine area, 2-8° C cool room, and qualified freezers at -20° C and -80° C for cell bank storage.