373 Model Based Integrated Design of Pharmaceutical Drug Substance Processes II


Description:
This session seeks contributions showcasing the development and implementation of first-principles as well as data-driven process modeling, simulation and optimization methods for design and development of pharmaceutical processes for the production of key intermediates and APIs. Modeling approaches including CFD, DEM, FEM, PBM, Monte Carlo and other methods, or a focus on thermodynamic, kinetic and transport parameter estimation, are welcome. Authors are encouraged to highlight Quality by Design (QbD) mapping approaches, process integration and intensification achievements, process economics and environmental impact analyses.

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


Chair:
Yuesheng Ye
Food and Drug Administration

Email: Yuesheng.Ye@fda.hhs.gov

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


Papers:
373a
Use of Model Discrimination Method in Drug Substance Process Development
Nil Tandogan, Eli Lilly and Company; Salvador García-Muñoz, Eli Lilly and Company; Maitraye Sen, Eli Lilly and Company; Thomas M. Wilson, Eli Lilly and Company; Jonas Y. Buser, Eli Lilly and Company; Stanley P. Kolis, Eli Lilly and Company; Indrakant V. Borkar, Eli Lilly Services India Pvt. Ltd.; Charles A. Alt, Eli Lilly and Company
373b
Model-Aided Development for a Mixed Anhydride Formation in a Drug Substance Manufacturing Process
Derek Starkey, Eli Lilly and Company; Carla Luciani, Eli Lilly and Company; Kevin P. Cole, Eli Lilly and Company; Justin Burt, Eli Lilly and Company; David Mitchell, Eli Lilly and Company
373c
Design of Efficient Metal Nanocatalysts for Cross Coupling Reactions Using Finite Difference Time-Domain Simulations
Andishaeh Dadgar, Oklahoma State University; Farshid Mohammadparast, Oklahoma state University; Marimuthu Andiappan, Oklahoma State University
373d
Nonlinear Optimisation of Continuous Artemisinin Crystallisation with Explicit NRTL Model-Based Solubility Prediction
Hikaru G. Jolliffe, University of Edinburgh; Dimitrios I. Gerogiorgis, University of Edinburgh
Break
373f
Multi-Layered Modelling Techniques for the Development of Continuous Manufacturing Processes
Philip Donnellan, University College Dublin; Roderick Jones, University College Dublin; Phillip Roche, Synthesis and Solid State Pharmaceutical Centre (SSPC), School of Chemical & Bioprocess Engineering, University College Dublin; Brian Glennon, University College Dublin
373g
A Refined Non-Random Two-Liquid Segment Activity Coefficient Model for Solubility Modeling
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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