478 Integrated Design for Drug Substance Processes

Wednesday, November 18, 2020: 8:00 AM - 9:00 AM
Pharmaceutical Discovery, Development and Manufacturing Forum (26) (PreRecorded+)

Description:
This session is one of the four sister sessions that encourages oral submissions to illustrate the advantages of integrating fundamental experimental designs and simulation tools to support development at laboratory and manufacturing scales for drug substance processes and applications. Topics related to fundamental process design and reaction kinetics leading to process optimization, integrated approach to understand various drug substance unit operations, and use of modeling tools for end-to-end continuous manufacturing are welcome in this session.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Chair:
Shujauddin M. Changi Email: shujauddin_changi@vrtx.com
Co-Chair:
Brian C. Anderson Email: Brian.C.Anderson@abbvie.com


(478b) Data-Driven Process Development and Scale-up of an Acetal Protection Reaction and Crystallization
Karthik Narsimhan, Joshua Lee, Jonathan McMullen, Eric Sirota and Anne Mohan


(478c) Model Development for Enzymatic Reactive Crystallization of β-Lactam Antibiotics: A Reaction-Diffusion-Crystallization Approach.
Hossein Salami, Matthew A. McDonald, Patrick R. Harris, Colton Lagerman, Martha A. Grover, Ronald W. Rousseau and Andreas S. Bommarius


(478e) Optimization of Process Risk, Cost, and Environmental Sustainability during Late Stage Drug Substance Control Strategy Development
Patrick Sipple, Matthew Hickey, Nathaniel D. Kopp, Jia Zang, Kenneth Fraunhoffer, Michaël Fenster and Jose E. Tabora


(478f) Digital Design of an Intensified Filtration-Drying Unit for Continuous Manufacturing
Francesco Destro, Inyoung Hur, Daniel M. Casas-Orozco, Su-Lin Lee, Mesfin Abdi, Xin Feng, Erin Wood, Massimiliano Barolo and Zoltan K. Nagy


(478g) Integrated Filtration and Washing Modelling to Predict Continuous Isolation Performance
Sara Ottoboni, Cameron Brown, Ekaterina Gramadnikova, Jan Sefcik and Chris Price