BIOT 199 |
| Current antibody processes target high titer, high concentration formulations, often nearly doubling throughput through the same manufacturing facility. To enable these processes, recent investigations into differing process performance focus on the effect of protein charge and conductivity on mass transfer coefficient and wall concentration of two monoclonal antibodies. Further investigation focused on linking diffusion coefficient and osmotic pressure to performance. Using a greatly simplified approach to data analysis, mass transfer and wall concentration values can be quickly determined and performance easily compared. Additionally, the use of lab-scale equipment decreased the material resource requirement for UF/DF process development by 10-fold and the labor requirement by 4-fold. Insight into parameters effecting performance, combined with lab-scale equipment and simplified data analysis, allows for a platform approach to ultrafiltration process development, enabling highly efficient formulations that meet high titer and high concentration needs. |
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Commercialization of Biologics: Characterization and Improvement of Platforms to Aid Commercialization of Biologics
8:00 AM-11:00 AM, Wednesday, August 22, 2007 BCEC -- 106, Oral
Division of Biochemical Technology |