34 Innovations in Pharmaceutical Discovery, Development, and Manufacturing


Description:
Innovative tools and techniques that impact pharmaceutical research and development are explored. Disruptive technologies that could greatly enhance drug discovery, process development, and manufacturing are discussed. This session will host presentations where new experimental capabilities and modeling efforts have led to impactful process improvements and fundamental information. The use of these approaches in drug substance, drug product, and biopharmaceutical are presented.

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


Chair:
Jonathan P. McMullen
Merck & Co. Inc.
Process R&D
P.O. Box 2000
Rahway, NJ
07065
Email: jonathan.mcmullen@merck.com

Co-Chair:
Christopher H. Marton
Principal Engineer
Celgene

Email: cmarton@celgene.com


Papers:
34a
Rational Design of Peptide Nucleic Acid Antibiotics Against Multidrug Resistant Bacteria
Thomas Aunins, University of Colorado Boulder; Colleen Courtney, University of Colorado Boulder; Kristen Eller, University of Colorado Boulder; Jocelyn Campos, University of Colorado Boulder; Keesha Erickson, University of Colorado Boulder; Anushree Chatterjee, University of Colorado Boulder
34b
Identifying CQAs of 3D Printed Extended-Release Tablets through the Optimization of Formulation and 3D Geometric Variables
Alaadin Alayoubi, FDA; Ahmed Zidan, FDA; Mohammad Sabir Aqueel, FDA; Celia N. Cruz, U.S. Food and Drug Administration; Muhammad Ashraf, Office of Testing and Research, U.S. Food and Drug Administration
34c
A Constrained Version of the Dynamic Response Surface Methodology for Challenging Time-Resolved Pharmaceutical Reaction Data
Yachao Dong, Tufts University; Christos Georgakis, Tufts University; Jason Mustakis, Pfizer Inc.; Joel M. Hawkins, Pfizer Inc.; Lu Han, Pfizer Inc.; Jonathan P. McMullen, Merck & Co. Inc.; Shane T. Grosser, Merck & Co., Inc.
34d
Characterizing Protein-Protein Interactions in Highly Concentrated Monoclonal Antibody Solutions Using Small Angle X-Ray Scattering and Molecular Dynamics Simulations
Amjad Chowdhury, The University of Texas at Austin; Barton J. Dear, The University of Texas at Austin; Jonathan A. Bollinger, Sandia National Laboratories; Jessica Hung, The University of Texas at Austin; P. Douglas Godfrin, Massachusetts Institute of Technology; Maria P. Nieto, The University of Texas at Austin; Tony Shay, The University of Texas at Austin; Logan Wilks, The University of Texas at Austin; Carl Karouta, The University of Texas at Austin; Thomas M. Truskett, The University of Texas at Austin; Keith P. Johnston, The University of Texas at Austin
34e
A Case Study and Design Considerations for the Robust Removal of Dissolved Hydrogen Chloride
Shujauddin M. Changi, Eli Lilly and Company; Jonas Y. Buser, Eli Lilly and Company; Matthew C. Embry, Eli Lilly and Company; Daniel Jarmer, Eli Lilly and Company; Christopher L. Burcham, Eli Lilly and Company; Radhe K. Vaid, Eli Lilly and Company; Adam D. McFarland, Eli Lilly and Company; Tim Pletcher, Eli Lilly and Company; Carla Luciani, Eli Lilly and Company; Kieran Kearney, Eli Lilly and Company; Nessa Mullane, Eli Lilly and Company; D Declan Hurley, Eli Lilly and Company
34f
Real-Time Monitoring of Drug Concentration in a Dropwise Additive Manufacturing System
Andrew J. Radcliffe, Purdue University; Zoltan K. Nagy, Purdue University; Gintaras V. Reklaitis, Purdue University
34g
Mechanistic Insights into a Process Intensification Strategy in Pharmaceutical Manufacturing
Kanjakha Pal, PURDUE UNIVERSITY; Zoltan K. Nagy, Purdue University
Abstract Submissions Closed
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