Spotlight on CDER Science! Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing- Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

A new CDER Spotlight has been posed. The topic is: “Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing.”

“Spotlight on CDER Science,” is the Center for Drug Evaluation and Research’s new on-line series. FDA scientists carry out laboratory, clinical and analytical research to address knowledge gaps in drug development, healthcare technologies and post-market drug monitoring. “Spotlight on CDER Science” features noteworthy scientific and research-oriented activities conducted within CDER.

The latest Spotlight is written by Sau (Larry) Lee, Ph.D., Deputy Director of the Office of Testing and Research, and Chair of the Emerging Technology Team, Office of Pharmaceutical Quality. For more than 50 years, pharmaceuticals have been produced using a method known as “batch manufacturing,” a multi-step, lengthy process that involves the use of ungainly, large-scale equipment. However, recent advances in manufacturing technology have prompted the pharmaceutical industry to consider moving away from batch manufacturing to a faster, more efficient process known as continuous manufacturing. The article presents an overview of the changes.

We hope you continue to enjoy this new series!

For more information, please visit: Continuous Manufacturing.