551 Predictive Scale-Up/Scale-Down for Production of Pharmaceuticals and Biopharmaceuticals

Wednesday, November 16, 2016: 12:30 PM - 3:00 PM
Continental 5 (Hilton San Francisco Union Square)
Description:
Batch processing in the pharmaceutical industry involves a series of unit operations where the synthesis and downstream processing of the chemical or biological product takes place in conjunction with mass, heat and momentum transfers. All of these processes are scale dependent and typically involve scaling-up from lab equipment to pilot scale and eventually to commercial scale operation. Similarly, operational issues experienced at commercial scale manufacturing (out of specification investigation, new impurity, raw material vendor change etc.) require a systematic scale-down approach to the lab scale in order to reproduce and investigate manufacturing problems before implementing solutions. Using predictive, first-principle based modeling as a guide during scale-up/scale down not only reduce the experiment cost with improved efficiency but also tremendously improve the process understanding which leads to better process control and improved product quality. This session invites papers that cover both theoretical and applicable aspects of scale-up/scale-down analysis across drug substance and drug product processes for small molecules as well as biological products.

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

Chair:
Mehrdad Kheiripour
Email: mehrdad.kheiripour@merck.com

Co-chairs:
Lin Zhu
Email: lin.zhu@abbvie.com

Niharika Chauhan
Email: niharika.chauhan@abbvie.com


12:30 PM
(551a) A Rapid, Materials-Sparing Approach to the Exploration of a Roller Compaction Process Design Space
Catherine Metzler, Pongpumin Bunchatheeravate, Gregory Buonocore, Hanlin Li, Hailey MacDonald, Ryan Peterson, Noreen Zaman and Joseph Bullard

12:52 PM
(551b) Advances in Discrete Element Modeling of High-Shear Wet Granulation Process Using Rocky-DEM
Preetanshu Pandey, Brenda Remy, Rahul Bharadwaj and Lucilla Almeida

1:14 PM
(551c) Scale-up of HME Process from a Trilobed 16mm to a Bilobed 27mm Extruder; SPH Simulations and 1D Mechanistic Modelling
Josip Matić, Stephan Laske, Amrit Paudel, François Pfefferlé, Jessica Lovey Martinetti, Sophie Martel and Johannes G. Khinast

1:58 PM
(551e) Scaling Intra-Tablet Coating Variability
Siddhartha Agarwal and Carl Wassgren

2:42 PM
(551g) Characterizing Mixing Time Scales in an Exothermic Mixing-Limited Reaction
Anuj A. Verma, Niharika Chauhan and Samrat Mukherjee