Tina Kiang, director of the Division of Regulations and Guidance in the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality, emphasized that although artificial intelligence (AI) is a useful tool in many areas of pharmaceutical manufacturing, humans are ultimately responsible for making decisions based on its outputs.
 
In her presentation at the recent CASSS Well-Characterized Biotechnology Products (WCBP) conference in Washington, DC, Kiang discussed how AI can be integrated into the manufacturing process and its application throughout the entire product lifecycle...[RAPS]