[Abstract]

Biologics has occupied a significant portion of the overall pharmaceutical industry in the last two decades. Currently, dozens of blockbuster therapeutic biologics are on the market and many more will be approved in the coming years. In addition, remarkable candidate molecules are being developed worldwide as novel therapies for autoimmune diseases, cancers, infectious diseases and rare diseases. When considering IND or BLA approval during drug development, it is now well known that CMC preparation should be carefully managed due to the complexity and uncertainty of biological drugs. In the first stage of development, the strategy and manufacturing plan should be designed according to the target product profile. Subsequently, the CMC activities are performed from CLD (cell line development) to higher scale manufacturing. Herein, I will review the procedures to prepare a CMC plan for biologics.