BIOT 58 |
| Rituximab (RituxanŽ) is a chimeric monoclonal antibody originally approved in the US for the treatment of Non-Hodgkins lymphoma in 1997. Market demand for the product has grown rapidly in the U.S. and the rest of the world since its approval, with 2005 U.S. sales exceeding $1.8B. The continued success of this product has triggered an ongoing need for expanded manufacturing capacity. This has been accomplished through a combination of process improvements and process transfers to additional manufacturing facilities. This presentation will review elements of the evolution of the rituximab manufacturing process as driven by factors including the need for increased supply, desires to enhance manufacturing safety and efficiency, and meeting emerging regulatory needs. The strategies followed in efficiently achieving increased manufacturing capacity will be described as will key lessons learned along the way in regards to process improvements, process transfers, and comparability assessments.. |
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Commercialization of Biologics: Case Studies: Post-Approval Changes & Comparability Challenges
2:00 PM-4:20 PM, Sunday, August 19, 2007 BCEC -- 109B, Oral
Division of Biochemical Technology |