Application of Quality by Design In API Process Development

Co-chair(s):
Katti, S., Genzyme Corporation

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.

Papers:
8:30 AM
(202a) Application of Design Space Mapping Accounting for Model Uncertainty and Common Cause Variability In Drug Substance Development
8:55 AM
(202b) Design Space Development for the Final Recrystallization Process for Axitinib, a Complex Solvating API
9:20 AM
(202c) Impurity Fate Mapping In the Development of Pazopanib
9:45 AM
(202d) A Model-Centric Solution to Link Content Uniformity Targets with API Particle Size Specifications and Process for a QbD Excercise
10:10 AM
(202e) Process QbD Case Study: An Integrated PAT Approach for a Dynamic Pharmaceutical Co-Precipitation Process Characterization and Process Design Space Development
10:35 AM
(202f) A QbD Approach to Improve Tablet Coating Uniformity

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Individuals

2011 Annual Meeting
AIChE Members $150.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $225.00
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only
AIChE Members $100.00
AIChE Food, Pharmaceutical & Bioengineering Division Members Free
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $150.00