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

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
Associate Research Scientist
Bristol-Myers Squibb Company
Pharmaceutical Research Institute
One Squibb Drive
New Brunswick, NJ 08903
Phone Number: 732-227-7838
Fax Number: 732-227-3008
Email: elizabeth.spiteri@bms.com

Co-chairs:

Pavol Rajniak and Kumar M. Dhanasekharan

Papers:

430a

Optimization of Monoclonal Antibody Production Using Process Simulation and Production Scheduling Tools
Charles Siletti, INTELLIGEN, INC.; Demetri Petrides, INTELLIGEN, INC.

430b

Safe Practices for Azide Chemistry Scale-up: A Case Study On a Pharmaceutical Intermediate
Nathaniel Kopp, Bristol-Myers Squibb Company; Francisco González-Bobes, Bristol-Myers Squibb Company; Joerg Deerberg, Bristol-Myers Squibb Company; Michael Hrytsak, Bristol-Myers Squibb Company; Simon Leung, Bristol-Myers Squibb Company; Praveen Sharma, Bristol-Myers Squibb Company

430c

Modeling of Cake Filtration – Applications in Predicting the On-Scale Filtration Performance of Various Pharmaceutical Intermediates
Saravanababu Murugesan, Bristol-Myers Squibb Co; Jose Tabora, Bristol-Myers Squibb Co; Daniel Hallow, Bristol-Myers Squibb Co; James Vernille, Bristol-Myers Squibb Co; Jean Tom, Bristol-Myers Squibb Co; Peter Clark, Dynochem

430d

Control of Deamidation of Monoclonal Antibodies in Mammalian Cell Culture Processes
John C. Chen, MedImmune, LLC; Thoa Bui, MedImmune, LLC; Vaibhav Hegde, MedImmune, LLC; Saravanamoorthy Rajendran, MedImmune, LLC; Dhara Mandavia, MedImmune, LLC; Methal Albarghouti, MedImmune, LLC

Break

430e

Impact of Scale On Wet Mill Performance
Josh D. Engstrom, Bristol-Myers Squibb; Deniz Erdemir, Bristol-Myers Squibb; Aghogho Pedro, Bristol-Myers Squibb; Kavita Vemishetti, Bristol-Myers Squibb; Chiajen Lai, Bristol-Myers Squibb; Jason Sweeney, Bristol-Myers Squibb

430f

Qualification of a Scale Down Cell Culture Model for Process Characterization Studies
Lia Tescione, Biogen Idec; James Lambropoulos, Biogen Idec; Kyle McElearney, Biogen Idec; Ram Paranandi, Biogen Idec; Rashmi Kshirsagar, Biogen Idec; Helena Yusuf-Makagiansar, Biogen Idec; Thomas Ryll, Biogen Idec

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

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