117.Routier FH,Davies MJ,Bergemann K,Hounsell EF.1997.The glycosylation pattern of humanized IgGI antibody(D1.3)expressed in CHO cells.

Glycoconj J14:201–207.

118.Ma S,Nashabeh W.1999.Carbohydrate analysis of a chimeric recombinant monoclonal antibody by capillary electrophoresis with laser-induced fluorescence detection.Anal Chem71:5185–5192.

119.Matamoros Fernandez LE,Kalume DE,Calvo L, Fernandez Mallo M,Vallin A,Roepstorff P.2001.

Characterization of a recombinant monoclonal antibody by mass spectrometry combined with liquid chromatography.J Chromatogr B Biomed Sci Appl752:247–261.

120.Kemminer SE,Conradt HS,Nimtz M,Sagi D, Peter-Katalinic J,Diekmann O,Drmic I,Muthing J.2001.Production and molecular characteriza-tion of clinical phase i anti-melanoma mouse IgG3 monoclonal antibody R24.Biotechnol Prog17: 809–821.

121.Davies J,Jiang L,Pan LZ,LaBarre MJ,Anderson D,Reff M.2001.Expression of GnTIII in a recom-binant anti-CD20CHO production cell line: Expression of antibodies with altered glycoforms leads to an increase in ADCC through higher affinity for FC gamma RIII.Biotechnol Bioeng 74:288–294.

122.Wang L,Amphlett G,Lambert JM,Blattler W, Zhang W.2005.Structural characterization of a recombinant monoclonal antibody by electrospray time-of-flight mass spectrometry.Pharm Res22: 1338–1349(Epub2005Aug1333.)

123.Wang F,Nakouzi A,Alvarez M,Zaragoza O, Angeletti RH,Casadevall A.2006.Structural and functional characterization of glycosylation in an immunoglobulin G1to Cryptococcus neo-formans glucuronoxylomannan.Mol Immunol 43:987–998.(Epub2005Jul2019.)

124.Siemiatkoski J,Lyubarskaya Y,Houde D,Tep S, Mhatre R.2006.A comparison of three techniques for quantitative carbohydrate analysis used in characterization of therapeutic antibodies.Carbo-hydr Res341:410–419.(Epub2005Dec2027.) 125.Kroon DJ,Freedy J,Burinsky DJ,Sharma B.

1995.Rapid profiling of carbohydrate glycoforms in monoclonal antibodies using MALDI/TOF mass spectrometry.J Pharm Biomed Anal13:1049–1054.

126.Sunday BR.2003.Structure characterization of a recombinant monoclonal antibody with one-and two-dimensional high performance liquid chro-matography with on-line electrospray ionization mass spectrometry.Bioprocessing J May/June: 37–43.

127.Wan HZ,Kaneshiro S,Frenz J,Cacia J.2001.

Rapid method for monitoring galactosylation levels during recombinant antibody production

by electrospray mass spectrometry with selec-tive-ion monitoring.J Chromatogr A913:437–446. 128.Tandai M,Endo T,Sasaki S,Masuho Y,Kochibe N,Kobata A.1991.Structural study of the sugar moieties of monoclonal antibodies secreted by human-mouse hybridoma.Arch Biochem Biophys 291:339–348.

129.Ip CC,Miller WJ,Silberklang M,Mark GE,Ellis RW,Huang L,Glushka J,Van Halbeek H,Zhu J, Alhadeff JA.1994.Structural characterization of the N-glycans of a humanized anti-CD18murine immunoglobulin G.Arch Biochem Biophys308: 387–399.

130.Hills AE,Patel A,Boyd P,James DC.2001.Meta-bolic control of recombinant monoclonal antibody N-glycosylation in GS-NS0cells.Biotechnol Bioeng75:239–251.

131.Bailey MJ,Hooker AD,Adams CS,Zhang S, James DC.2005.A platform for high-throughput molecular characterization of recombinant mono-clonal antibodies.J Chromatogr B Analyt Technol Biomed Life Sci826:177–187.(Epub2005Sep2019.) 132.Krotkiewski H,Gronberg G,Krotkiewska B,Nils-son B,Svensson S.1990.The carbohydrate struc-tures of a mouse monoclonal IgG antibody O KT3.

J Biol Chem265:20195–20201.

133.Bihoreau N,Ramon C,Lazard M,Schmitter JM.

bination of capillary electrophoresis and matrix-assisted laser desorption ionization mass spectrometry for glycosylation analysis of

a human monoclonal anti-Rhesus(D)antibody.

J Chromatogr B Biomed Sci Appl697:123–133.

134.Kunkel JP,Jan DC,Jamieson JC,Butler M.1998.

Dissolved oxygen concentration in serum-free con-tinuous culture affects N-linked glycosylation of a monoclonal antibody.J Biotechnol62:55–71. 135.Muthing J,Kemminer SE,Conradt HS,Sagi D, Nimtz M,Karst U,Peter-Katalinic J.2003.Effects of buffering conditions and culture pH on produc-tion rates and glycosylation of clinical phase I anti-melanoma mouse IgG3monoclonal antibody R24.

Biotechnol Bioeng83:321–334.

136.Raju TS,Scallon BJ.2006.Glycosylation in the Fc domain of IgG increases resistance to proteolytic cleavage by papain.Biochem Biophys Res Com-mun341:797–803.(Epub2006Jan2019.)

137.Lund J,Takahashi N,Nakagawa H,Goodall M, Bentley T,Hindley SA,Tyler R,Jefferis R.1993.

Control of IgG/Fc glycosylation:A comparison of oligosaccharides from chimeric human/mouse and mouse subclass immunoglobulin Gs.Mol Immunol 30:741–748.

138.Sheeley DM,Merrill BM,Taylor LC.1997.Char-acterization of monoclonal antibody glycosylation: Comparison of expression systems and identifica-tion of terminal alpha-linked galactose.Anal Bio-chem247:102–110.

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