Although FMEA and DOE are not new concepts for the development of biotech processes, linking the establishment of design space to the relevant CQA is novel. For example, a chromatography step that ...

When 3D printing was first introduced in 1985, it marked a major turning point for the manufacturing industry. In addition to ...

Biotechnology has enormous potential to solve some of the world’s most pressing challenges in health, food security, and the environment. Yet conventional methods for developing biotechnology ...