Session: Scale-up Issues in Bio/Pharmaceutical Process Development (2009 Annual Meeting)

Wednesday, November 11, 2009: 12:30 PM

Jackson B (Gaylord Opryland Hotel)

Description:

Scale-up issues in bio/pharmaceutical process development. We invite talks from scale-up case examples from unit operations labs to small pilot plants to manufacturing scale, or other scale leaps which encountered engineering-related issues. Scale-down examples that capture the manufacturing-scale issues for troubleshooting and exploring design space are also welcome.

Sponsor:

Pharmaceuticals

Co-Sponsor(s):

Pilot Plants (12b)

Chair:

Elizabeth Spiteri
Email: elizabeth.spiteri@bms.com

Co-chairs:

12:30 PM

(430a) Optimization of Monoclonal Antibody Production Using Process Simulation and Production Scheduling Tools
Charles Siletti and Demetri Petrides

12:50 PM

(430b) Safe Practices for Azide Chemistry Scale-up: A Case Study On a Pharmaceutical Intermediate
Nathaniel Kopp, Francisco González-Bobes, Joerg Deerberg, Michael Hrytsak, Simon Leung and Praveen Sharma

1:10 PM

(430c) Modeling of Cake Filtration – Applications in Predicting the On-Scale Filtration Performance of Various Pharmaceutical Intermediates
Saravanababu Murugesan, Jose Tabora, Daniel Hallow, James Vernille, Jean Tom and Peter Clark

1:30 PM

(430d) Control of Deamidation of Monoclonal Antibodies in Mammalian Cell Culture Processes
John C. Chen, Thoa Bui, Vaibhav Hegde, Saravanamoorthy Rajendran, Dhara Mandavia and Methal Albarghouti

1:50 PM

Break

2:00 PM

(430e) Impact of Scale On Wet Mill Performance
Josh D. Engstrom, Deniz Erdemir, Aghogho Pedro, Kavita Vemishetti, Chiajen Lai and Jason Sweeney

2:20 PM

(430f) Qualification of a Scale Down Cell Culture Model for Process Characterization Studies
Lia Tescione, James Lambropoulos, Kyle McElearney, Ram Paranandi, Rashmi Kshirsagar, Helena Yusuf-Makagiansar and Thomas Ryll

See more of this Group/Topical: Food, Pharmaceutical & Bioengineering Division