Application of Quality by Design In Drug Product Process Development I

Monday, October 17, 2011: 12:30 PM
Symphony III (Hilton Minneapolis)

The application of Quality by Design principles is beginning to be well established in the pharmaceutical industry. In particular, the demonstration of the science and risk-based approaches being applied to specific subsets of the drug product design or processing has been discussed intensively during the past several years. Therefore, it is now time to widen the scope of QbD across multiple unit operations, including important aspects of the drug substance. This session invites presentations in which drug products have been designed and developed demonstrating a holistic QbD approach. Papers concerning small and large molecules, including biologics, are being considered. The goal of this session is to demonstrate QbD being applied across multiple unit operations and integrating aspects of the API.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Pharmaceuticals (15b), Process Research and Innovation (12a)

Mary T. Am Ende

Johannes Khinast

- indicates paper has an Extended Abstract file available on CD.

File available
12:30 PM
(68a) Practical Applications of QbD for a Parenteral Drug Product
Nancy J. Harper, Venkat Koganti and Gautam R. Ranade

12:50 PM
(68b) Rational Design and Scale-up of Batch Lubrication Processes for Immediate Release Formulations
Joseph Kushner IV, Daniel O. Blackwood, Bruce C. MacDonald, Mark Polizzi, Francis M. Moore and Bruno C. Hancock

1:10 PM
(68c) Automation and Control of Drug-On-Demand Technology
Laura Hirshfield, Arun Giridhar, Gintaras V. Reklaitis, Venkat Venkatasubramanian and Michael T. Harris

File available
1:30 PM
(68d) Dynamic Flowsheet Modeling and Sensitivity Analysis of Continuous Pharmaceutical Manufacturing
Fani Boukouvala, Vasilis Niotis, Lukasz Mioduszewski, Aditya U. Vanarase, Rohit Ramachandran, Fernando. J Muzzio and Marianthi G. Ierapetritou

2:10 PM
(68f) Real-Time Process Management and Knowledge Management for Continuous Pharmaceutical Manufacturing
Girish Joglekar, Arun Giridhar, Gintaras V. Reklaitis and Venkat Venkatasubramanian