Session: Application of Quality by Design in API Process Development (2012 Annual Meeting)

Description:

Modernization of regulatory processes in the pharmaceutical industry has led to several innovative approaches to risk-based implementation of Quality by Design. Speakers for this session should include topics describing their application of QbD principles with examples of determination of critical process parameters (CPPs), mapping of design spaces (DS), real time process monitoring, and the determination of appropriate control strategies for small and large molecule drug substance processes.

Sponsor:

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Co-Sponsor(s):

Process Development Division (12)

Chair:

Partha Mudipalli
Associate Director
Cephalon, Inc.
API Technologies
145 Brandywine Parkway
West Chester, PA 19380
Fax Number: 610-883-5751
Email: pmudipal@cephalon.com

Co-Chair:

Joe Hannon
DynoChem Inc
Wilmington, DE 19803
Email: joe.hannon@scale-up.com

Papers:

Welcoming Remarks

466a

Application of Quality by Design Principles for An Existing Product for the Control of the Dimer Impurity in the Manufacturing Process
Gautam Samanta, Dr. Reddy's Laboratories Ltd.; Praveen K Sharma, Dr. Reddy's Lab; S Srividhya, Dr. Reddy's Lab; Kamlesh Pai Fondekar, Dr. Reddy's Lab; K R Janardan Sarma, Dr. Reddy's Lab; Saurabh Gupta, Dr. Reddy's Lab; Grb Ravish, Dr. Reddy's Lab; Y Raghuram, DR. Reddy's Lab

466b

Investigation of the Impact of Mode of Operation (Batch vs Flow) On Design Space Map
Shankar Vaidyaraman, Eli Lilly and Company; Sze Wing Wong, Eli Lilly and Company; Shekhar K. Viswanath, Eli Lilly and Company

466c

A QbD Approach to the Process Development of Tofacitinib
Bob Dugger, Pfizer Inc

Break

466d

Design of a Pharmaceutical Manufacturing Process Using QbD Principles: The Challenge of Technical Transfer to Manufacturing and Lifecycle Development
Conor Collins, GlaxoSmithKline; Steve Ball, GlaxoSmithKline

466e

Strategy and Process for Effective Scale-up On the Removal of Pd During the Synthesis of A Drug Substance
Alexander Chu-Kung, Abbott Laboratories; Hsien-Hsin Tung, Abbott Laboratories

466f

Implementation of Reaction Modeling and Process Analytical Technology in Design Space Development
Daniel Hallow, Bristol-Myers Squibb Company; Michael Fenster, Bristol-Myers Squibb Company; Antonio Ramirez, Bristol-Myers Squibb Company; Robert Wethman, Bristol-Myers Squibb Company; Nathan Domagalski, Bristol-Myers Squibb Company

466g

Application of Quality by Design in API Process Development
Nirav Shah, Umetrics; Conny Vikstrom, Umetrics; Erik Johansson, Umetrics

Concluding Remarks

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

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