572 Applications of Continuous Processing in the Manufacture of Pharmaceuticals: Drug Product II

Wednesday, November 11, 2015: 3:15 PM - 5:45 PM
Ballroom B (Salt Palace Convention Center)

As an advanced manufacturing mode, continuous manufacturing has been highlighted by the FDA’s regulatory science strategic plan (2011). Recently, the US president announced new actions to further strength US manufacturing (2014). Although the concept of continuous manufacturing has been widely used in some other processing industrial sectors, it is relatively new to the pharmaceutical sector. In this session, we invite submissions that discuss the most recent development in the following topics: (1) how classical chemical engineering concepts can be applied to process/equipment design and modeling for pharmaceutical continuous manufacturing of drug products, from unit operations to entire drug product manufacturing lines; (2) how advanced process control strategies such as innovative PAT can be applied for pharmaceutical continuous manufacturing process to ensure process consistency and drug product quality; (3) technical and regulatory challenges surrounding pharmaceutical continuous process. In addition, highly innovative applications of continuous manufacturing from other industrial sectors are welcome, too.

Pharmaceutical Discovery, Development and Manufacturing Forum
Pharmaceuticals (15B)
Kenneth J. Ford Email: keford@shire.com
Sarina Ma Email: Sarina.Ma@gilead.com

3:20 PM
(572a) Characterization and Modeling of Feeders: A Critical Component in Continuous Pharmaceutical Manufacturing
M. Sebastian Escotet-Espinoza, Eric Jayjock, Ravendra Singh, Aditya Vanarase, Fernando J. Muzzio and Marianthi Ierapetritou

3:40 PM
(572b) An Investigation of Mixing Performance of a Continuous Powder Mixing Process
William R. Ketterhagen, Daniel O. Blackwood, Jeff Moriarty, Yang Liu, Alex Bonnassieux, Steve McLellan and Stephanie Dolph

4:00 PM
(572c) Comparison of Continuous High Shear Granulation Processes with Twin-Screw Wet Granulation Process
Wei Meng, Sarang Oka, Savitha Panikar, Rohit Ramachandran and Fernando J. Muzzio

4:20 PM

4:25 PM
(572d) Experimental Investigation Linking Granulation Performance with Residence Time and Granulation Liquid Distributions in Twin-Screw Granulation
Ashish Kumar, Maija Alakarjula, Valérie Vanhoorne, Maunu Toiviainen, Mikko Juuti, Chris Vervaet, Jarkko Ketolainen, Krist V. Gernaey, Ingmar Nopens and Thomas De Beer

4:45 PM
(572e) NANEX: A Continuous Hot-Melt Extrusion (HME) Process for Nano-Based Formulations
Ramona Baumgartner, Gerold Koscher, Johannes G. Khinast and Eva Roblegg

5:05 PM
(572f) Continuous Manufacturing of Immediate-Release Tablets from Hot-Melt Extruded Pellets
Theresa R. Hörmann, Stephan Laske, Gerold Koscher and Johannes G. Khinast