Paper Number
PO23 

Session
Poster Session

Title
Examination of the viscosity of a monoclonal antibody solution as a predictor of viral filtration performance

Presentation Date and Time
October 14, 2015 (Wednesday) 6:05

Track / Room
Poster Session / Atrium/Harborview

Authors (Click on name to view author profile)

1. Stewart, Kevin D. (MedImmune, a division of AstraZeneca plc, Protein Purification Sciences)
2. Pathak, Jai (Medimmune, Formulation Sciences Department)
3. Newell, Kelcy J. (MedImmune, a division of AstraZeneca plc, Protein Purification Sciences)
4. Dickson, Matthew (MedImmune, a division of AstraZeneca plc, Protein Purification Sciences)

Author and Affiliation Lines (in printed abstract book)
Kevin D. Stewart¹, Jai Pathak², Kelcy J. Newell¹, and Matthew Dickson^1
1Protein Purification Sciences, MedImmune, a division of AstraZeneca plc, Gaithersburg, MD 20878; ²Formulation Sciences Department, Medimmune, Gaithersburg, MD 20878

Speaker / Presenter 
Stewart, Kevin D.

Text of Abstract
During optimization of a viral filtration step for a therapeutic monoclonal antibody (mAb), the mAb solution exhibited poor virus filter throughput. Virus filtration is a standard purification step used in virtually all mammalian cell culture-derived clinical manufacturing processes. To minimize costs associated with viral clearance evaluations and to minimize commercial manufacturing costs and processing time, there is a drive to find predictors of viral filtration performance to maximize virus filter throughput. An examination of mAb solution viscosity under various solution conditions, including the addition of a chaotropic agent, was performed to determine if a correlation could be established between solution viscosity and viral filtration throughput performance. Preliminary results suggest a correlation between the mAb solution viscosity and virus filtration throughput at a given pH.