Innovations in Scale-Up/Scale-Down of Pharmaceutical Unit Operations


Description:
Scale-up of pharmaceutical unit operations can be challenging as process performance may be scale dependent. The lack of fundamental understanding of the mechanisms governing process performance can lead to broad assumptions during process design, poor identification of critical process parameters, and scale-up complications which are not easily explained. Development of lab scale platforms that serve as scale-down models for pharmaceutical unit operations can provide insights into key mechanisms, streamline process development and drive efficiency. This session seeks papers highlighting innovations in scale-up/scale-down of pharmaceutical unit operations or case studies highlighting common challenges which were overcome by employing particle technology principles.

Sponsor:
Applications of Particle Technology for Pharmaceuticals


Chair:
Preetanshu Pandey
Bristol-Myers Squibb
Pharmaceutical Development
453 Engineering Science Building, PO Box 6102
New Brunswick, NJ
26506
Email: preetanshu.pandey@bms.com

Co-Chair:
Julianna Magnus
Merck and Co.
Pharmaceutical Commercialization Technology
West Point, PA
Email: julianna.magnus@merck.com


Papers:
Spray Drying Scale-up Based on a Development By Design Approach
Rui C. Silva, Hovione; Cláudia Moura, Hovione FarmaCiência SA; João Vicente, Hovione FarmaCiência SA; Márcio Temtem, Hovione FarmaCiência SA
Large Scale Discrete Element Modeling (DEM) Using Rocky Multi-GPU Solver for Various Process Equipment
Rahul Bharadwaj, ESSS North America; Lucilla Almeida, ESSS NA Inc; Brenda Remy, Bristol-Myers Squibb Co.; Preetanshu Pandey, Bristol-Myers Squibb
Scale up of Dry Granulation from Pilot Scale to Commercial Manufacturing
John Gawel, Bristol-Myers Squibb; Admassu Abebe, Bristol-Myers Squibb; Preetanshu Pandey, Bristol-Myers Squibb; Steve Pafiakis, Bristol-Myers Squibb; Jing Tao, Bristol-Myers Squibb
Role of the Ejection Process in the Capping of Pharmaceutical Biconvex Tablet after Compaction: A FEM Study
Vincent Mazel, Univ. Bordeaux; Harona Diarra, Univ. Bordeaux; Virginie Busignies, Univ. Bordeaux; Pierre Tchoreloff, Univ. Bordeaux
Abstract Submissions Closed