BIOT 192 |
| Systems biology views an organism through an integrated and interacting network of complex biochemical pathways. This provides a framework for combining detailed micro-level understanding of individual pathways to create a better understanding of the entire organism. Analogous to biological systems, commercial manufacturing processes for biologics are complex combinations of unit operations that interact and integrate with each other and ultimately produce a complex product with significant microheterogenity. This presentation highlights the relevance of taking a systems approach towards understanding the relevant details of each unit operation and how they combine together to create a well controlled process that operates at multiple commercial manufacturing sites to produce consistent and high quality drug substance. Characterizing the operational design space for each unit operation is an important first step. Even more important is understanding the interplay between various process steps and how they combine together to influence key product attributes. Several case studies of process characterization and validation study designs to highlight this interplay will be presented for both upstream and downstream processes. |
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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 |