Session: TI Application of Quality by Design In API Process Development (2010 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):

Pharmaceuticals (15b)

Chair:

Kevin D. Seibert
Eli Lilly & Co.
Cpr&d
DC 4813
Indianapolis, IN 46221
Phone Number: 317-651-7734
Email: seibertkd@lilly.com

Co-Chair:

Christine Seymour
Pfizer
Pfizer Global Research & Development
MS 7040-1208
Groton, CT 06340
Phone Number: 860-686-1011
Email: christine.b.seymour@pfizer.com

Papers:

673a

A Lab-Scale Investigation Into Drying of An Active Pharmaceutical Ingredient to Gain Process Understanding for Application in Full-Scale Manufacture
Holly Shearer, AstraZeneca

673b

Pragmatic Application of Crystallization Design Basics for a Pharmaceutical Compound
James Wertman, GlaxoSmithKline; Megan Ackers, GlaxoSmithKline; Philip Dell'Orco, GlaxoSmithKline

673c

A Risk-Based Approach to the Application of Biocatalysis for Manufacture of Small Molecule APIs
Stuart Goodall, Pfizer Inc; John Wong, Pfizer Inc; Gregory Finch, Pfizer Inc; Timothy J. Watson, Pfizer, Inc; Deborah Finco, Pfizer Inc; Ned Mozier, Pfizer Inc

673d

Modeling Approach for the Scale-up of a Reactive Distillation System
Isabel Figueroa, Eli Lilly and Company; Shekhar Viswanath, Eli Lilly and Company

673e

Sequential Design of Experiments for Design Space Definition of the Crystallization of An Active Pharmaceutical Ingredient
Eric Sirota, Merck & Co.; James P. Corry, Merck & Co.; Ralph Calabria, Merck & Co.; Paul James, Merck & Co.; Shane Grosser, Merck & Co.; Luke Schenck, Merck & Co.; Aaron Cote, Merck & Co.; Aaron Moment, Merck & Co.

673f

Plantwide Dynamic Simulation and Model-Based Control of a Continuous Pharmaceutical Process
Dimitrios I. Gerogiorgis, Massachusetts Institute of Technology (M.I.T.)

673g

Quality Control by QbD-Guided Optimization of Reaction and Crystallization
Evan T. Barlow, Bristol-Myers Squibb; Frederic Buono, Bristol-Myers Squibb; Thomas Laporte, Bristol-Myers Squibb; Jaan Pesti, Bristol-Myers Squibb; Lori Spangler, Bristol-Myers Squibb

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

<< Previous Session | Next Session >>