BIOT 105 |
| Humira (Adalimumab) was successfully launched in 2002 and is currently manufactured at both 3,000L and 6,000L scales. During the past three years of manufacturing, there has been a continuous effort to: (1) increase process robustness and ensure high quality, (2) satisfy and harmonize divergent global regulatory demands, and (3) ensure that an identical process could be launched at the 12,000L scale. First generation process improvements were developed in 2003 and implemented in 2004 to improve process robustness and harmonize the processes at different scales. Process mapping studies were undertaken in 2004 to refine our knowledge of process attributes like intermediate purity, yield and the dynamic performance of each unit operation. As a result, a fine-tuned revised adalimumab downstream process is currently submitted for approval and planned for 12,000L start up. Data from at scale validation demonstrating improved product quality, HCP clearance, and yield will be presented. |
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Downstream Processing: Bioprocess Integration & Industrial Case-Studies
3:00 PM-5:20 PM, Monday, August 20, 2007 BCEC -- 107 A/B, Oral
Division of Biochemical Technology |