645 Application of Process Modelling to Pharmaceutical Process Design and Scale-up


Description:
These sessions illustrate the advantages of integrating fundamental design concepts into process development to support pharmaceutical manufacturing, with an emphasis on scale-up considerations and case studies. Drug substance and drug product applications are both considered for this session track. Contributions that incorporate process modeling with experimental designs to optimize product performance in drug substance and/or drug product are encouraged for submission. Modeling approaches including CFD, DEM, FEM, PBM, Monte Carlo and other methods, or a focus on thermodynamic, kinetic and transport parameter estimation, are welcomed.

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


Chair:
Mary T. am Ende
Research Fellow
Worldwide Research and Development, Pfizer Inc.
445 Eastern Point Road
Groton, CT
06340
Email: mary.t.am.ende@pfizer.com

Co-chairs:
Michael L. Hoffman
Abbvie Laboratories
100 Abbott Park Road
Abbott Park, IL
60064-3500
Email: Michael.Hoffman@abbvie.com

Mehrdad Kheiripour
Manager
Neurocrine Biosciences Inc
Process Design & Engineering
160 Convent Avenue

10031
Email: mkheiripour@neurocrine.com


Papers:
Importance of the Rheological Characterization on the Spray Performance of Pharmaceutical Formulations
Tiago Porfirio, Hovione; Rui C. Silva, Hovione; João Vicente, Hovione; Viriato Semião, Instituto Superior Tecnico, University of Lisbon
Scaling up and Optimization of Process Parameters for a Spray Drying Plant Using Mechanistic Modelling
Sridevi Challa, Dr. Reddy's Laboratories Ltd.; Yakoob Sardar Mohammed, Dr. Reddy's Laboratories Ltd.; Veera Pratap Reddy Kasina, Dr. Reddy's Laboratories Ltd.; RaviChandra Palaparthi, Dr. Reddy's Laboratories Ltd.; Srividya Ramakrishnan, Dr. Reddy's Laboratories Ltd.; Ravi Kumar Gorle, Dr. Reddy's Laboratories Ltd.
Industrial Application of Mechanistic Model for Fluid-Bed Granulation for Technology Transfer and Design Space Exploration
David R. Ochsenbein, Janssen; Matthew W. Billups, Rutgers University; Bingbing Hong, Janssen; Elisabeth Schäfer, Janssen; Alexander J. Marchut, Janssen; Olav Lyngberg, Janssen
Practical Application of a Mechanistic Model for Twin Screw Granulation for Pharmaceutical Process Development
Dana Barrasso, Process Systems Enterprise; Leonor Rosa, Process Systems Enterprise; Sean K. Bermingham, Process Systems Enterprise; Gavin Reynolds, AstraZeneca
Ibrance® Capsule Commercial Process: Designed for Robustness
Mary T. am Ende, Worldwide Research and Development, Pfizer Inc.; John Kresevic, Pfizer, Inc.; Matthew P. Mullarney, Pfizer Inc.; Holger Schlack, Pfizer; William R. Ketterhagen, AbbVie
Application of Integrated Modeling Approach for Quality-By-Design (QbD) Process Development of Lyophilization
Kushal Sinha, AbbVie Inc.; Tong Zhu, Purdue University; Ehab Moussa, AbbVie Inc.; Deliang Zhou, AbbVie Inc.; Madeleine Witting, AbbVie Inc.; Nandkishor Nere, AbbVie; Sherwin Shang, AbbVie Inc.; Mario Hirth, AbbVie Inc.; Martin Bultmann, AbbVie Inc.; Nupur Dutta, AbbVie Inc.; Ted Tharp, AbbVie Inc.; Feroz Jameel, AbbVie Inc.; Martin Gastens, AbbVie Inc.; Alina Alexeenko, Purdue University
Drug Product Process Modeling
Mary T. am Ende, Worldwide Research and Development, Pfizer Inc.; William R. Ketterhagen, AbbVie; Andrew Prpich, Pfizer; Salvador García-Muñoz, D; Pankaj Doshi, Worldwide Research and Development, Pfizer Inc.; Rahul Bharadwaj, ESSS North America
Abstract Submissions Closed