299 Model Based Integrated Design of Pharmaceutical Drug Substance Processes I


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:
299a
Intensification of a Continuous Process Guided By Mechanistic Modeling
Rudi Oliveira, Hovione FarmaCiência SA; Ana Cruz, Hovione FarmaCiência SA; Filipe Ataíde, Hovione FarmaCiência SA; Nuno Matos, Hovione FarmaCiência SA
299b
Simultaneous Estimation of Kinetic Parameters and Curve Resolution of Spectral Data -  Applications and Extensions
Salvador García-Muñoz, Eli Lilly and Company; Lorenz T. Biegler, Carnegie Mellon University; Weifeng Chen, Zhejiang University of Technology
299c
Modeling and Monitoring of a Continuous Silylation Reaction
Edward Conder, Eli Lilly and Company; Carla Luciani, Eli Lilly and Company; Jonas Y. Buser, Eli Lilly and Company; Jeffrey Tan, Eli Lilly & Co; Adam D. McFarland, Eli Lilly and Company; Matthew C. Embry, Eli Lilly and Company; Scott A. May, Eli Lilly and Company; Mark S. Kerr, Eli Lilly and Company; Luke Webster, Eli Lilly and Company
299d
Estimability Analysis for Improved Parameter Estimation in Deterministic Models: Pharmaceutical Case Studies
Maitraye Sen, Eli Lilly and Company; Salvador García-Muñoz, Eli Lilly and Company; Nil Tandogan, Eli Lilly and Company; Indrakant V. Borkar, Eli Lilly Services India Pvt. Ltd.; Stanley P. Kolis, Eli Lilly and Company; Thomas M. Wilson, Eli Lilly and Company; Jonas Y. Buser, Eli Lilly and Company; Charles A. Alt, Eli Lilly and Company
299e
Solubility Data Mining and Predictive Modeling: AI+ChE
Jacob Albrecht, Bristol-Myers Squibb Company; Jun Qiu, Bristol-Myers Squibb Co.
299f
Toward Efficient Development and Reliable Scale-up of Agitated Filter Drying Protocol through DEM Modeling and Simulation
Kushal Sinha, AbbVie Inc.; Nandkishor Nere, AbbVie Inc.; John G. Gaertner, AbbVie Inc.; Laurie Mlinar, AbbVie Inc.; Raimundo Ho, AbbVie Inc.; Alessandra Mattei, AbbVie Inc.; Haojuan Wei, AbbVie Inc.; Samrat Mukherjee, AbbVie Inc.; Ahmad Sheikh, AbbVie Inc.; Shailendra Bordawekar, AbbVie Inc.
Abstract Submissions Closed
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