328 Continuous Processing Technologies Applied in Drug Substance Manufacturing I


Description:
Continuous manufacturing is an emerging 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 technologies on the drug substance/API discovery and process development. The accepted talks in this session includes the most recent developments in the following areas: (1) Dynamic experiment in flow process for the optimization and kinetic investigations, (2) Development of integrated autonomous continuous flow chemistry platform capable of multi-step syntheses, and robotic reconfigurability, (3) Design and characterization of 3D-printed production scale static mixers mixing in lab and production scale, (4) Development of Trickle bed reactor for hydrogenation, (5) Multiscale Modeling of a Plug Flow Reactor, (6) Integrated Quality by Design by incorporating dynamic and feedback control, and (7) residence time distribution (RTD) model.

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


Chair:
Marimuthu Andiappan
Assistant Professor
Oklahoma State University
School of Chemical Engineering
Stillwater, OK
Email: mari.andiappan@okstate.edu

Co-Chair:
Cuixian Yang
Senior Scientist
Merck & Co., Inc.
Chemical Engineering Research and Development
Rahway, NJ
Email: cuixian.yang@merck.com


Papers:
Multidimensional Dynamic Experiments in Flow As a Kinetic Platform for Data Rich Experimentation in Pharmaceutical Process Development
Brian M. Wyvratt, Merck & Co., Inc.; Jonathan P. McMullen, Merck & Co. Inc.; Shane T. Grosser, Merck & Co., Inc.
Autonomous Reaction Platform for Continuous Chemical Synthesis
Dale Thomas, Massachusetts Institute of Technology; Connor W. Coley, Massachusetts Institute of Technology; Victor Schultz, Rensselaer Polytechnic Institute; Justin Lummiss, MIT; Jonathan Jaworski, MIT; Luke Rogers, Massachusetts Institute of Technology; Anastasios J. Hart, Massachusetts Institute of Technology; Klavs F. Jensen, Massachusetts Institute of Technology; Timothy Jamison, Massachusetts Institute of Technology
Advancing Flow Chemistry Portability: Approach to Crossing the Chasm
John R. Naber, Merck & Co. Inc.; Francois Levesque, Merck & Co. Inc.; Nicholas Rogus, Merck & Co. Inc.; Glenn Spencer, Merck & Co. Inc.; Plamen Grigorov, Merck & Co. Inc.; Jonathan P. McMullen, Merck & Co. Inc.; David A. Thaisrivongs, Merck & Co. Inc.; Ian W. Davies, Princeton University
Multiscale Modeling of a Plug Flow Reactor for a Continuous Drug Substance Manufacturing Process
Nima Yazdanpanah, U.S. Food and Drug Administration; Thomas O'Connor, U.S. Food and Drug Administration; Celia N. Cruz, U.S. Food and Drug Administration
Integrated Quality By Design for Continuous Pharmaceutical Manufacturing: Accounting for Dynamics and Feedback
Lucas Foguth, Massachusetts Institute of Technology; Eranda Harinath, Sanofi Genzyme; Joel Paulson, University of California - Berkeley; Richard D. Braatz, Massachusetts Institute of Technology
Material Tracking in a Fully Continuous Drug Substance Process
Carla Luciani, Eli Lilly and Company; Stephen B. Jeffery, Eli Lilly and Company; Jon Dieringer, Eli Lilly & Co; Robert Manson, Kenny-Whelan Associates Ltd; Edmond Kennedy, Eli Lilly & Co; Aoife Corrigan, Eli Lilly & Co; Martin Johnson, Eli Lilly and Company; Scott A. May, Eli Lilly and Company
Abstract Submissions Closed