594 Continuous Processing Technologies Applied in Drug Substance Manufacturing


Description:
Enabled by new technology, continuous processing offers new methods of increasing safety, selectivity, quality, consistency, agility and yield for chemical and biochemical processes. Improved control over process streams enables operation at optimum conditions with reduced sensitivity to scale-up effects. This session will focus on applications of continuous processing to the production of drug substances and products or their intermediates. The session is keen to attract papers which provide an insight to continuous processing state of the art and its association to industrial application in the manufacturing environment.

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:
594a
Advanced Control Strategy Approaches for Continuous Pharmaceutical Manufacturing: The Regulatory Landscape
Thomas O'Connor, U.S. Food and Drug Administration
594b
Pharmacy-on-Demand: A Continuous Revolution in Pharmaceutical Manufacturing?
Luke Rogers, Massachusetts Institute of Technology; Ramona Achermann, ETH; Andrea Adamo, Massachusetts Institute of Technology; Mohsen Behnam, Worcester Polytechnic Institute; Rachel Beingessner, Massachusetts Institute of Technology; Dave Brancazio, MIT; Naomi Briggs, MIT; Jie Chen, Massachusetts Institute of Technology; Gregory Hammersmith, MIT; Timothy Jamison, Massachusetts Institute of Technology; Klavs F. Jensen, Massachusetts Institute of Technology; Guahua Liang, MIT; Hongkun Lin, Massachusetts Institute of Technology; Allan S. Myerson, Massachusetts Institute of Technology; Clemence Neurohr, MIT; Carter Salz, MIT; Ridade Sayin, Purdue University; David Snead, Georgia Pacific; Dale Thomas, MIT; Nopphon Weeranoppanant, Massachusetts Institute of Technology; Lukas Weimann, ETH; Shin Yee Wong, Massachusetts Institute of Technology; Ping Zhang, Novartis
594c
Platforms for Integrated Continuous Drug Subtance Design and Manufacture
Anna Przybyl, APC Ltd; Gary Morris, APC Ltd; Richard Wareham, APC Ltd; Brian Glennon, APC; Mark Barrett, APC Ltd
594d
Residence Time Distribution and Material Traceability for Continuous Drug Substance Processes
Christopher S. Polster, Eli Lilly and Company; Venkata Ramana Reddy, Eli Lilly & Co; Carla Luciani, Eli Lilly and Company; Stephen B. Jeffery, Eli Lilly and Company; Martin Johnson, Eli Lilly and Company; Kevin Chinn, TruTag Technologies Inc; Hod Finkelstein, TruTag Technologies Inc
594e
A Miniature CSTR Platform for Continuous Processing of Multiphase Systems
Yiming Mo, MIT; Klavs F. Jensen, Massachusetts Institute of Technology
594f
From Grams of Drug Substance to Commercial Scale Clinical Supply Manufacture in Less Than a Year
Carl Hartmann III, Eli Lilly
594g
A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses
Thomas De Beer, Ghent University
Abstract Submissions Closed
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