Fc-Fusion Proteins: A Growing Class of Therapeutics - Austropa ...

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Bioprocessing Challenges ofFusion ProteinsWorkshop on Fusion ProteinsESACT Conference, 15 May 2011, ViennaMichiel E. Ultee, Ph.D., CSOLaureate Biopharmaceutical Services
Fusion Proteins are Created byMolecular Biologists, Not Nature• Not selected by eonsof evolution fordesirable propertiessuch as– Expression rate– Stable structure– Different portions ofthe molecule notinterfering with othersCoagulation Factor VIIConfidentialSlide 2
Page 6 and 7: Design of CD4IgG• Assembles into
Page 8 and 9: 34 Therapeutic monoclonal antibody/
Page 10 and 11: Potential production issues with Fc
Page 12 and 13: Presentations• Engineering a CHO
Page 14 and 15: Cell Line Development Process Desir
Page 16 and 17: How Components Impact on Yield• E
Page 18 and 19: CONFIDENTIAL10VHc250 AntibodyCombin
Page 20 and 21: Approaches to Debottleneck Protein
Page 22 and 23: Inefficient Processing and Secretio
Page 24 and 25: Chaperones operating in the ER…So
Page 26 and 27: Metabolically Engineered CellsLow-P
Page 28 and 29: Volumetric Productivity in Fed Batc
Page 30 and 31: ConclusionsBottlenecks are specific
Page 34 and 35: First Example: Fc-Fusion + mFactor
Page 36 and 37: Temper Expectations on Expression R
Page 38 and 39: Fusion Proteins Tend to AggregateCo
Page 40 and 41: Other Strategies for Protein A Elut
Page 42 and 43: Removal of Aggregates -- SEC• Whe
Page 44 and 45: Even Nanofiltration Can be Problema

Fc-Fusion Proteins: A Growing Class of Therapeutics - Austropa ...

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