344 Application of Quality By Design in Drug Product Process Development I

Description:
Quality by Design (QbD) as applied to the process development of pharmaceutical drug products.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum

Chair:
Sarina G. Harris Ma
Email: sarina.ma@xenoport.com

Co-Chair:
Lauren Wiser
Email: lauren.wiser@gilead.com


Papers:

3:15 PM
(344a) Manufacturing of Low Fill Weight Capsules Using a Nozzle Dosator Capsule Filling Machine
Marcos Llusá, Eva Faulhammer, Marlies Fink, Georg Scharrer, Vittorio Calzolari, Stefano Biserni, Simon Lawrence, Massimo Bresciani and Johannes G. Khinast

3:40 PM
(344b) Drug-On-Demand: A Mini-Manufacturing Method Using Drop-On-Demand Technology
Laura Hirshfield, Gintaras V. Reklaitis, Arun Giridhar and Michael T. Harris

4:55 PM
(344e) Parametric Analysis of Fluidized Bed Drying of Pharmaceutical Materials
Xue Liu, Fernando Muzzio, Johannes G. Khinast and Benjamin Glasser

5:20 PM
(344f) Linking Powder Bed Heterogeneities to Tableting Performance
Ilgaz Akseli, Nadia Ladyzhynsky, Xiaorong He and Rich Deanne