418 Continuous Processing Technologies Applied in Drug Substance Development Chemistry


Description:
Continuous manufacturing is a new paradigm in the pharmaceutical industry. In recent years, a number of pharmaceutical companies, academic institutions and equipment/technology providers have been highly involved in the development of continuous processes for pharmaceutical manufacturing. This session is focused on the applications of continuous manufacturing as applied during drug product discovery and process development. In this session we invite submissions related to the most recent developments in the following areas: (1) Case studies on process development, mathematical modeling of continuous manufacturing unit operations as well as full manufacturing lines, (2) Development of innovative PAT and advanced process control methodologies, (3) Other technical, manufacturing and regulatory challenges involved in continuous manufacturing.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B), Next-Gen Manufacturing (T6A)


Chair:
Mark Barrett
APC Ltd
Dublin 4
4
Email: mark.barrett@approcess.com

Co-Chair:
Joe Hannon
DynoChem Inc
Wilmington, DE
19803
Email: joe.hannon@scale-up.com


Papers:
Overcoming Challenges for Scale-up of Continuous Pharmaceutical Drug Substance Processes
Shujauddin M. Changi, Eli Lilly and Company; Donal Harrold, Eli Lilly and Company; Harold Moloney, Eli Lilly and Company; Martin Johnson, Eli Lilly and Company; Scott A. May, Eli Lilly and Company; Timothy M. Braden, Eli Lilly and Company; Luke Webster, Eli Lilly and Company; Joel Calvin, Eli Lilly and Company; Carla Luciani, Eli Lilly and Company
Preparation of Hazardous “on-Demand” Reagents Using Continuous Processing
Sarah Rothstein, Nalas Engineering Services Inc.; Jerry S. Salan, Nalas Engineering Services Inc.; David am Ende, Nalas Engineering Services Inc.; Matthew Jorgensen, Nalas Engineering Services Inc.; Trevor Rosensohn, Nalas Engineering Services Inc.
Model-Aided Development for a Continuous Amide Bond Formation in a Drug Substance Manufacturing Process
Derek Starkey, Eli Lilly and Company; Carla Luciani, Eli Lilly and Company; Matthew C. Embry, Eli Lilly and Company; Molly Hess, Eli Lilly and Company; Justin Burt, Eli Lilly and Company; David Mitchell, Eli Lilly and Company
Effects of Catalyst and Metals Pretreatment for the Continuous Hydrogenation of a Halogenated Aromatic Nitro Compound
Christopher Lippelt, Eli Lilly and Company; Jonas Y. Buser, Eli Lilly and Company; Bradley M. Campbell, Eli Lilly and Company; Richard F. Cope, Eli Lilly and Company; Michael Laurila, Eli Lilly and Company
Large Scale Production of  Pharmaceutical Intermediates in the Flow Mode
Baoquan Sun, SynTheAll (STA); Sam Tadayon, SynTheAll (STA)
Plasmonic Metal Nanocatalysts As Platform for Continuous Synthesis of Drug Substances
Farshid Mohammadparast, Oklahoma state University; Andishaeh Dadgar, Oklahoma State University; Marimuthu Andiappan, Oklahoma State University
Developing Scale-up Approach for a Fast Reactions in Continuous Flow
Plamen Grigorov, Merck and Co. Inc.; Azzedine Lekhal, Merck and Co. Inc.; Marco Armenante, Merck and Co. Inc.; Nicholas Rogus, Merck and Co. Inc.; Glenn Spencer, Merck and Co. Inc.; David A. Thaisrivongs, Merck and Co. Inc.; John R. Naber, Merck and Co. Inc.
Abstract Submissions Closed