Cell Lines Vendors Selection for Biological products

The performance of bioprocesses and the quality of the biologic drug substances they produce is determined by the cell lines. An obvious choice that most sponsors of biosimilar programs make is to choose the same host as the one used by the manufacturer of the reference product. Many factors influence the selection of a quality cell line for a given biologic drug substance. The capacity of the cell line to cope with the secretory stresses associated with the high level of protein production, particularly with many of the newer, non-natural proteins such as bi-specifics or multi-specifics, is also important. It is worth considering that biologically derived products are more complex in magnitude as compared to the traditional drugs. Genetic stability testing should also be performed using methods such as good manufacturing practices (GMP) sequencing, Northern and Southern blotting, and copy number by quantitative polymerase chain reaction (qPCR).