Session: Application of Quality by Design In API Process Development (2011 Annual Meeting)

Tuesday, October 18, 2011: 8:30 AM

Symphony III (Hilton Minneapolis)

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):

Pharmaceuticals (15b)

Chair:

Kevin D. Seibert
Email: seibertkd@lilly.com

Co-Chair:

Sanjeev Katti
Email: sanjeev.katti@genzyme.com

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

8:30 AM

(202a) Application of Design Space Mapping Accounting for Model Uncertainty and Common Cause Variability In Drug Substance Development
Shankar Vaidyaraman, Isabel Figueroa, Sze Wing Wong and Shekhar Viswanath

8:55 AM

(202b) Design Space Development for the Final Recrystallization Process for Axitinib, a Complex Solvating API
Steven M. Guinness, Brian P. Chekal and Gregory S. Steeno

9:20 AM

(202c) Impurity Fate Mapping In the Development of Pazopanib
Michael A. McGuire

9:45 AM

(202d) A Model-Centric Solution to Link Content Uniformity Targets with API Particle Size Specifications and Process for a QbD Excercise
Salvador García-Muñoz, Weili Yu, Mark A. Pinto and Sean K. Bermingham

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
Huiquan Wu and Mansoor A Khan

10:35 AM

(202f) A QbD Approach to Improve Tablet Coating Uniformity
Atul Dubey, Fani Boukouvala, Golshid Keyvan, Richard Hsia, Kostas Saranteas, Dean Brone, Tushar Misra, Marianthi Ierapetritou and Fernando. J Muzzio

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

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