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

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34 Therapeutic monoclonal antibody/Fc-fusion protein approvals—USATechnologyYearApproval2011 Benlysta Yervoy2010 Prolia/XgevaActemra2009 Arzerra StelaraIlaris Simponi2008 Nplate Arcalyst2007 Soliris2006 Vectibix Lucentis*2005 Orencia2004 ErbituxAvastinTysabri2003XolairBexxar**RaptivaAmeviveFc- Fusion Protein2002Zevalin**HumiraHuman20012000CampathMylotarg***Humanized1998Simulect Synagis Remicade HerceptinEnbrelChimeric1997RituxanZenapaxMouse19941984ReoPro*Orthoclone OKT38*Fab or (Fab) 2 antibody fragment**Immunoconjugate
USA-approved Fc-fusion proteinsBrandnameGenericnameSponsorYearapprovedConstructTargetbindingdomain IgdomainMW (kDa)Expression systemTargetClinicalindicationEnbrel etanercept Immunex/Amgen1998 TNFR2 ϒ1 Fc 150 CHO TNF Rheumatoidarthritis;juvenileidiopathicarthritis;psoriasisAmevive alefacept Biogen-Idec2003 LFA3 ϒ1 Fc 92 CHO CD2 PsoriasisOrencia abatacept BMS 2005 CTLA4 ϒ1 Fc 92 CHO CD28(indirect)Arcalyst rilonacept Regeneron 2008 IL1-RIIL1RAcPNplate romiplostim Amgen 2008 Peptidemimetic ofTPO9Rheumatoidarthritis;juvenileidiopathicarthritisϒ1 Fc 251 CHO IL1 Cryopyrinassociatedperiodicsyndromesϒ1Fc,fusionat Cterm59 E. coli TPOR Chronicidiopathicthrombocytopenic purpura
Page 6 and 7: Design of CD4IgG• Assembles into
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 32 and 33: Bioprocessing Challenges ofFusion P
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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