119 Application of Quality by Design in Drug Substance Process Development

Monday, November 9, 2015: 12:30 PM - 3:00 PM
Ballroom B (Salt Palace Convention Center)

The pharmaceutical industry is increasingly implementing Quality by Design (QbD) to ensure robust and efficient processing through novel applications of process knowledge, technology, and risk management. Speakers for this session should include topics describing their application of QbD principles with examples such as determining critical process parameters (CPPs), mapping of design spaces (DS), controlling processes in real-time, and the developing appropriate control strategies for small and large molecule drug substance processes.

Pharmaceutical Discovery, Development and Manufacturing Forum
Pharmaceuticals (15B)
Daniel Hallow Email: dhallow@ITS.JNJ.com
Haojuan Wei Email: haojuan.wei@abbvie.com
- indicates paper has an Extended Abstract file available on CD.

1:19 PM
(119c) Continuous Solid-Liquid Separation in Pharmaceutical Manufacturing
Johannes S. Gursch, Roland Hohl, Diana Dujmovic, Stephan Laske, Joerg Brozio, Markus Krumme, Norbert Rasenack and Johannes G. Khinast

1:43 PM

2:12 PM
(119e) Prediction of Feasible Operating Region for an Integrated Set of Unit Operations
Carla Luciani, Salvador García-Muñoz, Kevin Seibert, Thomas Wilson and Eric Crick