FDA Grand Rounds

Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology

Thursday, March 12, 2020

12:00 p.m. - 1:00 p.m. EST

WO Building 2, Room 2047 (or via webcast)

Register here for webcast (public attendees and FDA staff)

CE Credit Available

Presented by:

Thomas O’Connor, Ph.D.

Senior Chemical Engineer

Office of Testing Research, Office of Pharmaceutical Quality

CDER

About the Presentation:

Drug makers have used cutting-edge science to discover medicines, but they have generally manufactured these medicines using techniques that have not progressed much over the past decades. Accelerating the development and adoption of pharmaceutical manufacturing innovations is needed to keep pace with advances and evolution in drug clinical research and development. It is also a key component of long-term strategies aimed at addressing the underlying causes of product recalls and shortages.

One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing (CM). This approach transforms the traditional, step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. It enables a steady output of finished drug products as raw materials are continuously added to the closed system.

3D printing is another approach to advanced manufacturing. These methods are capable of manufacturing pre-determined 3D geometric structures of solid drug products in various shapes, strengths and distributions of active and inactive ingredients. This approach provides a unique opportunity to produce medicines that are tailored for individual needs of patients.

This presentation will provide an overview of these advanced manufacturing technologies methodologies, discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.

What you’ll learn from this FDA Chemical Engineer:

Ways in which the FDA supports the adoption of innovation in pharmaceutical manufacturing
Examples of advanced manufacturing for pharmaceutical and ways in which these innovations can increase the quality assurance of drugs taken by patients
Why research is needed to support CDER’s Emerging Technology Program

www.FDA.gov/GrandRounds

https://collaboration.fda.gov/grand/ (adobe link for webcast)