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OFFICE OF NEW DRUGS MODULE

Unique Characteristics

A distinguishing characteristic of biotechnology products is the diverse sources of expression systems and raw materials used in their manufacture. There are transgenic animals, and eukaryotic and prokaryotic expression systems. Products are made in the cells of mice. There are human cells or human cell-derived cell lines that can be used in culture, and there are serum-derived products developed in human cells and used for biologics.

There are hundreds of pre-license files for products in clinical development for a wide range of uses. In addition, FDA regulates products already on the market, including biologics license applications (BLAs), new drug applications (NDAs) and antibodies used for cell selection devices.

a scientist holding a petri dish
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Topic: page 1 of 3 (Lesson: page 8 of 24)