542 Integrated Design for Small and Large Molecule Process Development

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 highlights recent advances made in integrating fundamental and applied studies for small and large molecule process development. Topics related to various technologies, work streams, and scientific tools will be covered (e.g. hot melt extrusion, coating processes, bio-pharmaceutical platforms, etc.). Use of computational approaches or other process system tools to drive scale-up understanding, manufacturing decisions, improve process safety, and enhance understanding of process uncertainties/risks across API and bio-pharmaceutical (proteins, monoclonal antibodies, etc.) are sought for herein.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Chair:
Tim Boung-Wook Lee Email: boung-wook.x.lee@gsk.com
Co-Chair:
Pallavi Pawar Email: pallavi.x.pawar@gsk.com


(542a) Continuous Mixing Technology: Development of Digital Twin
Peter Toson, Pankaj Doshi, Eva Siegmann, Daniel O. Blackwood, Kai Lee, James Kimber, Jenna Brandon, David Wilsdon, Ashwinkumar Jain, Johannes G. Khinast and Dalibor Jajcevic



(542d) Developing HME-Based Drug Products Using QbD and Emerging Science
Josip Matić, Hannes Bauer, Amrit Paudel and Johannes G. Khinast


(542e) First-Principles Dynamic Simulation of an Integrated Continuous Biomanufacturing Platform
Moo Sun Hong, Amos E. Lu, Andrew J. Maloney, Elizabeth M. Cummings Bende, Dragana Bozinovski, Jose Sangerman, Anastasia Artamonova, Rui Wen Ou, Paul W. Barone, Jacqueline Wolfrum, Stacy Springs, Anthony J Sinskey and Richard Braatz


(542f) A Comprehensive Investigation of Process Design and Parameters of Spray Dried Proteins
Daniela Fiedler, Sonja Hartl, Tanja Gerlza, Christina Trojacher, Andreas Kungl, Eva Roblegg and Johannes G. Khinast