342 Continuous Processing in the Manufacture of Pharmaceuticals: Drug Product I

Tuesday, November 15, 2016: 12:30 PM - 3:00 PM
Continental 4 (Hilton San Francisco Union Square)
Description:
Continuous Processing in the Manufacture of Pharmaceuticals: Drug Product Continuous manufacturing is a new paradigm in the pharmaceutical industry. In the recent years, a number of pharmaceutical companies, academic institutions and the equipment/technology providers have been highly involved in the development of continuous processes for pharmaceutical manufacturing. This session is focused on the applications of continuous manufacturing for drug product. In this session we invite submissions related to the most recent developments in the following areas: (1) Case studies on process development, mathematical modeling of continuous manufacturing unit operations as well as full manufacturing lines, (2) Development of innovative PAT and advanced process control methodologies, (3) Other technical, manufacturing and regulatory challenges involved in continuous manufacturing.

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

Chair:
Aditya Vanarase
Email: Aditya.Vanarase@bms.com

Co-chairs:
Robert F. Meyer
Email: robert_meyer2@merck.com

Sarina Ma
Email: Sarina.Ma@gilead.com


12:30 PM
(342a) Streamlined Design for Continuous Production of a Pharmaceutical Drug Product
Stephen L. Conway, Robert F. Meyer, Frank D. Witulski, Manoharan Ramasamy, Oliver Clarke, Palmerly Tom, Mason Gibbs, Mark Purcell, Lalloo Anita, Julie Pentz, Ken Thompson, Brendon G. Ricart, Jon Hoza, Donghui Hong, Gina Thompson, Philip Cryan and Andrew Owen

12:49 PM
(342b) Flowsheet Modeling of a Continuous Direct Compression Process at Production Scale
Shaun Galbraith, Bumjoon Cha, Zhuangrong Huang, Seongkyu Yoon, Robert F. Meyer, Samantha Hurley and Matthew H. Flamm

1:27 PM
(342d) Establishing a Procedure for Transferring HME Processes Using Physical Similarities
Theresa R. Hörmann, Ândreas Witschnigg, Michaela Zagler, Gerold Koscher, Stephan Laske and Johannes G. Khinast

2:24 PM
(342g) A Novel Analysis of Residence Time Distributions for Continuous Powder Mixing
Geng Tian, Xiaochuan Yang, Sau Lee, Robert Fisher, Shuaili Li, Moo Sun Hong, Zongyu Gu and Thomas O'Connor

2:43 PM
(342h) Model Based Loss-in-Weight Feeder Design and Optimization
Eric Jayjock and M. Sebastian Escotet-Espinoza