762 Quality by Design in Drug Substance Process Development


Description:
Modernization of regulatory processes in the pharmaceutical industry has led to several innovative approaches to risk-based implementation of Quality by Design. Speakers for this session should include topics describing their application of QbD principles with examples of determination of critical process parameters (CPPs), mapping of design spaces (DS), real time process monitoring, and the determination of appropriate control strategies for small and large molecule drug substance processes.

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


Chair:
Yang Yang
Senior Engineer
The Dow Chemical Company
Engineering & Process Science
Midland, MI
Phone Number: 989-636-3311
Email: yyang15@dow.com

Co-Chair:
Dominique Hebrault
Principal Scientist
METTLER TOLEDO AutoChem
Reaction Engineering
7075 Samuel Morse Dr.
Columbia, MA
21046
Email: Dominique.Hebrault@mt.com


Papers:
762a
Use of a Trickled Bed Reactor to Improve the Commercial Feasibility of the Hydrogenation of a Nitro-Compound
Carla Luciani, Eli Lilly and Company; Jonas Y. Buser, Eli Lilly and Company; Michael Laurila, Eli Lilly and Company; Richard Cope, Eli Lilly and Company; Kevin P. Cole, Eli Lilly and Company; Bradley M. Campbell, Eli Lilly and Company; Justin Burt, Eli Lilly and Company; Martin Johnson, Eli Lilly and Company; Joseph Martinelli, Eli Lilly and Company; David Mitchell, Eli Lilly and Company
762b
Use of Process Analytical Technology to Gain Mechanistic Insights into Spherical Agglomeration of Active Pharmaceutical Ingredients
Kanjakha Pal, PURDUE UNIVERSITY; Ramon Pena, Purdue University; Daniel Jarmer, Eli Lilly & Company; Christopher L. Burcham, Eli Lilly & Company; Zoltan K. Nagy, Purdue University
762c
Process Dynamics of Continuous Cooling Crystallization of Carbamazepine in a Mixed Suspension Mixed Product Removal (MSMPR) System
David A. Acevedo, Purdue University; Xiaochuan Yang, Food and Drug Administration; Adil Mohammad, Food and Drug Administration; Naresh Pavurala, U.S. Food and Drug Administration; Wei-Lee Wu, Food and Drug Administration; Thomas O'Connor, U.S. Food and Drug Administration; Sau Lee, Food and Drug Administration; Patrick J. Faustino, Food and Drug Administration; Zoltan K. Nagy, Purdue University; Celia N. Cruz, U.S. Food and Drug Administration
762d
Monte Carlo Stepwise Regression for More Accurate Selection of Critical Process Parameters during Process Characterization
Cary F. Opel, Gilead; Cerintha J. Hui, Gilead; Patrick Y. Yang, Gilead; Daniel J. Tien, Gilead
762e
Delivering a Design Space for a Continuous Drug Substance Manufacturing Process Using Simulation
Neil Hodnett, GlaxoSmithKline
762f
Estimating NRTL-SAC Conceptual Segments of Molecules Using Sigma Profile
Yifan Hao, Texas Tech University; M. R. Islam, Texas Tech University; Meng Wang, Texas Tech University; Chau-Chyun Chen, Texas Tech University
Abstract Submissions Closed
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