GMP Cell Banking
LuinaBio offers significant expertise and experience in establishing and maintaining cGMP cell banks. A suitable and stable master cell bank is crucial to product development and supports all phases of the product lifecycle 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 LuinaBio 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 offers both aerobic and anaerobic conditions. We offer in-house release and stability testing of cell banks and short and long-term storage in qualified freezers under continuous temperature monitoring. LuinaBio 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.