A.A.Shuklaetal./J.Chromatogr.B848(2007)28–3939
[42]R.vanReis,E.Goodrich,C.Yson,L.Frautschy,S.Dzengeleski,H.Lutz,[46]L.Conley,J.McPherson,J.Thommes,in:A.Rathore,G.Sofer(Eds.),
Biotechnol.Bioeng.55(1997)737.ProcessValidationinManufacturingofBiopharmaceuticals,Taylorand
[43]J.Seely,R.Seely,Biopharm.Int.(August)(2003)24.Francis,BocaRaton,FL,2005,p.469.
[44]R.Seely,J.Haury,in:A.Rathore,G.Sofer(Eds.),ProcessValidationin[47]C.Bussineau,R.Seely,G.Lovitt,J.Fernandez,G.Blank,E.Brandreth,D.
ManufacturingofBiopharmaceuticals,TaylorandFrancis,BocaRaton,Conrad,R.Devine,R.Ferris,K.deHeyder,R.Juffras,P.Levy,W.List,M.
FL,2005,p.13.Munk,B.Neely,S.Notarnicola,R.O’Leary,H.vanDeinse,PDAJournal
[45]R.Godavarti,J.Petrone,J.Robinson,R.Wright,B.Kelley,in:A.Rathore,TechnicalReport#4259(2005)1.
G.Sofer(Eds.),ProcessValidationinManufacturingofBiopharmaceuti-[48]D.Low,R.O’Leary,H.Pujar,J.Chromatogr.(2006)(JCB-06-583R1),
cals,TaylorandFrancis,BocaRaton,FL,2005,p.69.submittedforpublication. |
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