Symposium: (2010 Annual Meeting)

This preliminary program is subject to change.

Pharmaceuticals

The below sessions are either SPONSORED or CO-SPONSORED by this Area.

- indicates session contains Extended Abstract(s) available on CD.

Monday, November 8, 2010

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8:30 AM-11:00 AM

TI010 Scale-up of Pharmaceutical Manufacturing Processes: Toward a QbD Approach
Ecevit Bilgili and Mary T. Am Ende

15B06 Crystallization of Pharmaceutical and Biological Molecules 1: In Honour of the Late Dr. Jeff Wei of Eli Lilly
Ryan C. Snyder and Derek Griffin

12:30 PM-3:00 PM

TI000 Model Based Integrated Design of Pharmaceutical Drug Product and Process
Salvador Garcia-Munoz and Nick Sahinidis

02B00 Particle Formation and Crystallization Processes From Liquids, Slurries, and Emulsions I
Fang Wang and Ranjit Thakur

15B05 Reaction Engineering in API Synthesis
David J. am Ende and Adam S. Butterbaugh

3:15 PM-5:45 PM

15B01 Integrated API and Drug Product Development
Marylee Z. Southard and Hector Guzman

06004 Mixing in Multi-Phase Systems II
Piero Armenante and Terry Hudson

02B06 Particle Formation and Crystallization Processes From Liquids, Slurries, and Emulsions II
Bing-Shiou Yang and Guangwen He

TI003 Quality by Design in Generic Drug Development
Zhigang Sun and Yatindra Joshi

Tuesday, November 9, 2010

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8:30 AM-11:00 AM

15B10 Bioseparations / Downstream Processing of Biopharmaceuticals 2
Gregory Frank, Sydney D. Hoeltzli and Jessica R. Molek

TI002 Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment
Shailendra V. Bordawekar and Peter Clark

12:30 PM-3:00 PM

03A07 Characterization of Engineered Particulate Systems for Pharmaceutical Active Ingredient Delivery
Stephen P. Beaudoin and Ranjit Thakur

15B07 Bioseparations / Downstream Processing of Biopharmaceuticals 1
Gregory Frank, Sydney D. Hoeltzli and Jessica R. Molek

TI001 Quality-by-Design (QbD) Round Table Discussion Session: An Integrated and Science-Based Approach for Quality by Design (QbD) Implementation in Pharmaceutical Industry
Huiquan Wu and Christine Seymour

3:15 PM-5:45 PM

03A08 Engineered Composite Particulate Systems for Pharmaceutical Active Ingredient Delivery
Rajesh Dave and Christopher L. Burcham

15B11 Characterization and Processing Solutions for API and Drug Product
Marylee Z. Southard and Hector Guzman

15000 Food, Pharmaceutical and Bioengineering Plenary Session
Shang-Tian Yang and John A. Morgan

02B04 PAT for Crystallization Development and Manufacturing
Levente L. Simon and Jean Tom

TI008 QbD Topical Plenary Session
Paul C. Collins and Shekhar K. Viswanath

Wednesday, November 10, 2010

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8:30 AM-11:00 AM

15B12 Applications of Continuous Processing In the Pharmaceutical Industry
Paul Collins and Brian C. Anderson

TI004 Quality-by-Design (QbD): Techniques for Quality Risk Analysis and Management Over the Product Life Cycle
Huiquan Wu and Luke R. Schenck

20012 Reaction Engineering in Pharmaceuticals and Fine Chemicals
Sanjeev Katti and Yi Jiang

12:30 PM-3:00 PM

15B02 Applications of Continuous Processing in Manufacture of Drug Product
Nancy E. Sever and Ecevit Bilgili

TI009 Applications of Multivariate Data Analysis in Pharmaceutical Process Development
Sze Wing Wong and Jose E. Tabora

10A06 Bio and Pharmaceutical Process Design
Kyle V. Camarda and Laurence R. Weatherley

06012 Mixing and Scale-up/Scale-Down Strategies for the Production of Biopharmaceuticals
Alvin W. Nienow and Ashraf Amanullah

03C02 Mixing and Segregation of Particulates I
Steven W. Meier and Nestor A. Vasquez

3:15 PM-5:45 PM

15B08 Applications of Continuous Processing in Manufacture of Drug Substance / API
Ecevit Bilgili and Nancy E. Sever

TI011 Applications of PAT in a Manufacturing Setting
David Unger and Simon D. Fraser

6:00 PM-8:00 PM

15B03 Poster Session: Pharmaceutical Engineering
Joe Hannon and Partha Mudipalli

Thursday, November 11, 2010

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8:30 AM-11:00 AM

15B09 Crystallization of Pharmaceutical and Biological Molecules 2: In Honor of the Late Dr. Jeff Wei of Eli Lilly
Derek Griffin and Ryan C. Snyder

TI006 TI Application of Quality by Design in Drug Product Process Development
Kevin J. Bittorf and John C. Strong

12:30 PM-3:00 PM

15B04 Quantitative Use of Particle Characterization Data for Process Modelling
Pavol Rajniak and James Wertman

TI005 TI Application of Quality by Design In API Process Development
Kevin D. Seibert and Christine Seymour

3:15 PM-5:45 PM

15B00 Application of Green Chemical Engineering Approaches to Improve Sustainability in Pharmaceutical Manufacturing
James C. Marek and David J. am Ende

TI007 Model Based QbD in Drug Substance or Drug Product
Richard Schild and Nandkishor K. Nere