2017 Annual Meeting

Session: Quality by Design in Drug Substance Process Development

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.

Chair

Yang Yang, The Dow Chemical Company

Co-Chair

Presentations

03:15 PM

(762a) Use of a Trickled Bed Reactor to Improve the Commercial Feasibility of the Hydrogenation of a Nitro-Compound
Carla Luciani, Jonas Y. Buser, Michael Laurila, Richard Cope, Kevin P. Cole, Bradley M. Campbell, Justin Burt, Martin Johnson, Joseph Martinelli, David Mitchell

03:40 PM

(762b) Use of Process Analytical Technology to Gain Mechanistic Insights into Spherical Agglomeration of Active Pharmaceutical Ingredients
Ramon Pena, Kanjakha Pal, Daniel Jarmer, Christopher L. Burcham, Zoltan K. Nagy

04:05 PM

(762c) Process Dynamics of Continuous Cooling Crystallization of Carbamazepine in a Mixed Suspension Mixed Product Removal (MSMPR) System
Xiaochuan Yang, David A. Acevedo, Adil Mohammad, Thomas O'Connor, Sau Lee, Patrick J. Faustino, Zoltan K. Nagy, Celia Cruz, Naresh Pavurala, Wei-Lee Wu

04:30 PM

(762d) Monte Carlo Stepwise Regression for More Accurate Selection of Critical Process Parameters during Process Characterization
Cary F. Opel, Cerintha J. Hui, Patrick Y. Yang, Daniel J. Tien

04:55 PM

(762e) Delivering a Design Space for a Continuous Drug Substance Manufacturing Process Using Simulation
Neil Hodnett

05:20 PM

(762f) Estimating NRTL-SAC Conceptual Segments of Molecules Using Sigma Profile
Yifan Hao, M. R. Islam, Meng Wang, Chau-Chyun Chen