668 Application of Quality By Design in Drug Product Process Development II

Thursday, November 20, 2014: 12:30 PM
202 (Hilton Atlanta)
The importance of Quality-by-Design (QbD) for product process development has become increasingly apparent in the pharmaceutical industry, as this methodology promotes scientific and risk-based understanding during drug product development and scale-up. QbD approaches enable better product robustness and improved process control, the latter providing the potential to facilitate transition from batch to continuous manufacture. We invite submissions that demonstrate the application of QbD principles during process development of a drug product, especially when applied across multiple unit operations or to streamline drug product manufacture.

Pharmaceutical Discovery, Development and Manufacturing Forum

William R. Ketterhagen
Email: william.ketterhagen@pfizer.com

Zoltan K. Nagy
Email: zknagy@purdue.edu

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

12:30 PM
(668a) A Drop-on-Demand Manufacturing System for the Production of Melt-Based Pharmaceutical Dosage Forms
Elšin Išten, Arun V. Giridhar, Zoltan K. Nagy and Gintaras V. Reklaitis

12:55 PM
File available
1:45 PM
(668d) Determination of Design Space for Oral Pharmaceutical Drugs
Kaliopi Chatzizacharia and Dimitris Hatziavramidis

2:10 PM
(668e) Integrated Dynamic Real Time Optimization and Advanced Feedback Control of Continuous Tablet Manufacturing Process
Ravendra Singh, Maitraye Sen, Fernando Muzzio, Marianthi Ierapetritou and Rohit Ramachandran