Past Event

Continuous Manufacturing for the Modernization of Pharmaceutical Production: A Workshop

Workshop
July 30, 2018 - July 31, 2018

Location: National Academy of Sciences Building
2101 Constitution Ave NW Washington DC 20418



Confirmed Participants:
Janet Woodcock, Food and Drug Administration
Chris Love, Massachusetts Institute of Technology
Lindsay Arnold, MedImmune
Gintaras V. Reklaitis, Purdue University*
Charles Cooney, Massachusetts Institute of Technology*
D. Keith Roper, University of Arkansas*
Ken Lee, MedImmune*
Liuquan (Lucy) Chang, Merck*
Eva Gefroh, Just Biotherapeutics*
(*Member of Workshop Planning Committee)

The National Academies of Sciences, Engineering, and Medicine's Board on Chemical Sciences and Technology is hosting a workshop on Continuous Manufacturing for the Modernization of Pharmaceutical Production, which is sponsored by the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA).

This workshop will discuss the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics, such as enzymes, monoclonal antibodies, and vaccines. The workshop will discuss specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical, and drug product development. The workshop will address these challenges broadly across the biologics domain but to focus particularly on drug categories of greatest FDA and industrial interest, such as monoclonal antibodies.

Featuring presentations, panel discussions, and breakout sessions, this workshop will bring together experts in the production of biologically-derived pharmaceuticals and provide a rare opportunity for industry leaders and academics to have deep discussions with leadership from the FDA and BARDA. This meeting is open to the public and aims to have a variety of perspectives represented.