641 Model Based Integrated Design of Pharmaceutical Drug Substance and Drug Product and Processes

Thursday, November 20, 2014: 8:30 AM
202 (Hilton Atlanta)
Description:
This session focuses on work in which a mathematical modeling approach is taken for a combined pharmaceutical drug substance synthesis and drug product process with emphasis on impact on drug product performance and CQAs. The integrated modeling approach can be used for process understanding, design and/or optimization. Authors from both drug substance and drug product sides of the business are encouraged to submit an abstract.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum

Chair:
Daniel Patience
Email: daniel.b.patience@gsk.com

Co-chairs:
Dimitri Skliar
Email: dimitri.skliar@bms.com

Jeremy Merritt
Email: MERRITT_JEREMY_MILES@LILLY.COM

Bodhisattwa Chaudhuri
Email: Bodhi.Chaudhuri@uconn.edu

- indicates paper has an Extended Abstract file available on CD.

File available
8:30 AM
(641a) Simulation of Stirred Tank Hydrodynamics Using Mesh and Meshless Methods
P.J. Frawley, Dragan Nikolic, Brian de Souza, Giuseppe Cogoni and Brian Hogan

8:50 AM
(641b) Understanding of Pmdi-Spacer Interactions through CFD Simulations
Saurabh Sarkar, Maziar Kakhi, Prasad Peri and Bodhisattwa Chaudhuri

9:10 AM
(641c) Applying Poisson-Boltzmann Theory to Predict Excipient Concentration in Ultrafiltered Therapeutic Protein Formulations
John Robinson and Roger A. Hart

9:30 AM
(641d) Fluid Bed Granulation: Towards a Comprehensive Process Model
Robert Claudius Schardmüller, Markus Pieber, Gregor Toschkoff, Simon D. Fraser, Daniela Steigmiller, Bruno Chilian, Alfred Fetscher, Martin Maus, Michael Braun, Sean Bermingham, Johannes G. Khinast and Pavol Rajniak
File available
9:50 AM
(641e) The Simulation of Mixing and Free Surface Flows in Co-Rotating Twin-Screw Extruders
Andreas Eitzlmayr, István Kondor, Josip Matic, Gerold Koscher and Johannes G. Khinast

10:10 AM
(641f) Case Study: Simulation-Based Process Optimization for a Monoclonal Antibody Cation Exchange Step
Trent Larsen, Stephen Hunt, Ashish Sharma and Robert Todd

10:30 AM
(641g) Optimization of the Protein Pegylation Process
Xiaojiao Shang, Brandon Corbett, Prashant Mhaskar and Raja Ghosh
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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