BIOT 193 |
| Robust production at manufacturing facility is the ultimate goal for process scientists and engineers. To reach the goal, biopharmaceuticals face lots of challenges during the process development, process scale-up, process transfer, and final process demonstration at manufacturing scale, which would become more complicated to deal with under budget limitation, short project timeline, and disconnected organization communication situations. Overcoming these barriers has grown into a critical task for a biopharmaceutical company to survive in the current highly competitive environment. This presentation will focus on integrated and standardized approach to reduce the barrier for process transfer and scale-up. Integration involves process scientists and engineers to realize the “big picture” of tasks and to foresee the potential issues at the early stage. Standardization helps organization increase the efficiency and reduce the required resources. It can shorten project delivery time and save the invested capitals from the same or similar issues over and over again. Examples will be addressed to demonstrate the feasibility of these principles. |
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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 |