Session: QbD in Solid-Liquid Processes (2009 Annual Meeting)

Description:

This session covers QbD consideration for processes involving a solid suspended in a liquid phase. Crystallization and parenteral products are the main focus of this session. Contributions of interest are those involving process considerations and modeling, in-situ characterization of the product or incoming material selection.

Sponsor:

Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products

Chair:

Kostas Saranteas
Senior Director, Process Engineering
Sepracor Inc.
Chemical Process Research and Development
84 Waterford Drive
Marlborough, MA 01752
Phone Number: 508-357-7655
Email: kostas.saranteas@sepracor.com

Co-Chair:

Michael Pikal

Papers:

585a

A QbD Approach to Selection of Materials for Drug Product Packaging and Medical Devices
Arthur J. Shaw III, Pfizer Inc.

585b

Application of Modeling to Scale-up Liquid Mixing Processes
Venkat R. Koganti, Pfizer Global Research and Development; Fred Carroll, Pfizer Global Research and Development; Richard Ferraina, Pfizer Global Research and Development; Mark Berry, Pfizer Global Research and Development; Robert Leasure, Pfizer Global Research and Development; Jeffrey Gaudio, Pfizer Global Research and Development; Yang Liu, Pfizer Global Research and Development; Kenneth Norris, Pfizer Global Research and Development; Bryan Braxton, Pfizer Global Research and Development; WIlliam Petre, Pfizer Global Research and Development; Yogesh Waghmare, Bend Research Inc; Rick Falk, Bend Research Inc

585c

Application of Quality by Design Principles to Development of Freeze-Dried Parenteral Dosage Forms
Linas Mockus, Discovery Park; Michael Pikal, University of Connecticut; Nancy Harper, Pfizer Global R&D; Prabir K. Basu, Purdue University; Steven Nail, Baxter Pharmaceutical Solutions LLC; Nathan Pease, Baxter Pharmaceutical Solutions LLC; Mansoor A. Khan, Food and Drug Administratin; Tim Paul, Baxter Pharmaceutical Solutions LLC

585d

On the Optimization of the Cooling Profile in Crystallization Using the Design of Dynamic Experiments Approach
Andrew Hagger, Tufts University; Andrew Fiodalis, Tufts University; Christos Georgakis, Tufts University

585e

Quality-by-Design (QbD): Examining the Impact of Process Variables On Particle Size Distribution for a Pharmaceutical Co-Precipitation Process Using Real-Time Lasentec FBRM and PVM Process Monitoring and Design of Experiments (DoE) Approach
Huiquan Wu, FDA; Maury White, FDA; Mansoor A. Khan, Food and Drug Administratin

585f

The in Situ Analysis and Characterization of the Coprecipitation of a Model Drug and Polymer
Juandria V. Williams, Food and Drug Administration; Rakhi B. Shah, Food and Drug Administration; Huiquan Wu, Food and Drug Administration; Mansoor A. Khan, Food and Drug Administration

See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

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