NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods
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LEOZ DE, M.L.A., D.L. DUEWER, A. FUNG, L. LIU, H.K. YAU, O. POTTER, G.O. STAPLES, K. FURUKI, R. FRENKEL, Y.L. HU, Z. SOSIC, P.Q. ZHANG, F. ALTMANN, C. GRUNWALD-GRUBE, C. SHAO, J. ZAIA, W. EVERS, S. PENGELLEY, D. SUCKAU, A. WIECHMANN, A. RESEMANN, W. JABS, A. BECK, J.W. FROEHLICH, C.C. HUANG, Y. LI, Y.M. LIU, S.W. SUN, Y.J. WANG, Y. SEO, H.J. AN, N.C. REICHARDT, J.E. RUIZ, S. ARCHER-HARTMANN, P. AZADI, L. BELL, Z. LAKOS, Y.M. AN, J.F. CIPOLLO, M. PUCIC-BAKOVIC, J. STAMBUK, G. LAUC, X. LI, X. WANG, A. BOCK, R. HENNIG, E. RAPP, M. CRESKEY, T.D. CYR, M. NAKANO, T. SUGIYAMA, P.K.A. LEUNG, P. LINK-LENCZOWSKI, J. JAWOREK, S. YANG, H. ZHANG, T. KELLY, S. KLAPOETKE, R. CAO, J.Y. KIM, H.K. LEE, J.Y. LEE, J.S. YOO, S.R. KIM, S.K. SUH, N. DE HAAN, D. FALCK, G.S.M. LAGEVEEN-KAMMEIJER, M. WUHRER, R.J. EMERY, R.P. KOZAK, L.P. LIEW, L. ROYLE, P.A. URBANOWICZ, N.H. PACKER, X.M. SONG, A. EVEREST-DASS, Erika LATTOVÁ (703 Slovensko, garant, domácí), S. CAJIC, K. ALAGESAN, D. KOLARICH, T. KASALI, V. LINDO, Y. CHEN, K. GOSWAMI, B. GAU, R. AMUNUGAMA, R. JONES, C.J.M. STROOP, K. KATO, H. YAGI, S. KONDO, C.T. YUEN, A. HARAZONO, X.F. SHI, P.E. MAGNELLI, B.T. KASPER, L. MAHAL, D.J. HARVEY, R. FLAHERTY, P.M. RUDD, R. SALDOVA, E.S. HECHT, D.C. MUDDIMAN, J.C. KANG, P. BHOSKAR, D. MENARD, A. SAATI, C. MERLE, S. MAST, S. TEP, J. TRUONG, T. NISHIKAZE, S. SEKIYA, A. SHAFER, S. FUNAOKA, M. TOYODA, P. DE VREUGD, C. CARON, P. PRADHAN, N.C. TAN, Y. MECHREF, S. PATIL, J.S. ROHRER, R. CHAKRABARTI, D. DADKE, M. LAHORI, C.X. ZOU, C. CAIRO, B. REIZ, R.M. WHITTAL, C.B. LEBRILLA, L.R. WU, A. GUTTMAN, M. SZIGETI, B.G. KREMKOW, K.H. LEE, C. SIHLBOM, B. ADAMCZYK, C.S. JIN, N.G. KARLSSON, J. ORNROS, G. LARSON, J. NILSSON, B. MEYER, A. WIEGANDT, E. KOMATSU, H. PERREAULT, E.D. BODNAR, N. SAID, Y.N. FRANCOIS, E. LEIZE-WAGNER, S. MAIER, A. ZECK, A.J.R. HECK, Y. YANG, R. HASELBERG, Y.Q. YU, W. ALLEY, J.W. LEONE, H. YUAN a S.E. STEIN
A broad-based interlaboratory study of glycosylation profiles of a reference and modified IgG antibody involving 103 reports from 76 laboratories. Glycosylation is a topic of intense current interest in the development of biopharmaceuticals because it is related to drug safety and efficacy. This work describes results of an interlaboratory study on the glycosylation of the Primary Sample (PS) of NISTmAb, a monoclonal antibody reference material. Seventy-six laboratories from industry, university, research, government, and hospital sectors in Europe, North America, Asia, and Australia submitted a total of 103 reports on glycan distributions. The principal objective of this study was to report and compare results for the full range of analytical methods presently used in the glycosylation analysis of mAbs. Therefore, participation was unrestricted, with laboratories choosing their own measurement techniques. Protein glycosylation was determined in various ways, including at the level of intact mAb, protein fragments, glycopeptides, or released glycans, using a wide variety of methods for derivatization, separation, identification, and quantification. Consequently, the diversity of results was enormous, with the number of glycan compositions identified by each laboratory ranging from 4 to 48. In total, one hundred sixteen glycan compositions were reported, of which 57 compositions could be assigned consensus abundance values. These consensus medians provide community-derived values for NISTmAb PS. Agreement with the consensus medians did not depend on the specific method or laboratory type. The study provides a view of the current state-of-the-art for biologic glycosylation measurement and suggests a clear need for harmonization of glycosylation analysis methods.
LEOZ DE, M.L.A., D.L. DUEWER, A. FUNG, L. LIU, H.K. YAU, O. POTTER, G.O. STAPLES, K. FURUKI, R. FRENKEL, Y.L. HU, Z. SOSIC, P.Q. ZHANG, F. ALTMANN, C. GRUNWALD-GRUBE, C. SHAO, J. ZAIA, W. EVERS, S. PENGELLEY, D. SUCKAU, A. WIECHMANN, A. RESEMANN, W. JABS, A. BECK, J.W. FROEHLICH, C.C. HUANG, Y. LI, Y.M. LIU, S.W. SUN, Y.J. WANG, Y. SEO, H.J. AN, N.C. REICHARDT, J.E. RUIZ, S. ARCHER-HARTMANN, P. AZADI, L. BELL, Z. LAKOS, Y.M. AN, J.F. CIPOLLO, M. PUCIC-BAKOVIC, J. STAMBUK, G. LAUC, X. LI, X. WANG, A. BOCK, R. HENNIG, E. RAPP, M. CRESKEY, T.D. CYR, M. NAKANO, T. SUGIYAMA, P.K.A. LEUNG, P. LINK-LENCZOWSKI, J. JAWOREK, S. YANG, H. ZHANG, T. KELLY, S. KLAPOETKE, R. CAO, J.Y. KIM, H.K. LEE, J.Y. LEE, J.S. YOO, S.R. KIM, S.K. SUH, N. DE HAAN, D. FALCK, G.S.M. LAGEVEEN-KAMMEIJER, M. WUHRER, R.J. EMERY, R.P. KOZAK, L.P. LIEW, L. ROYLE, P.A. URBANOWICZ, N.H. PACKER, X.M. SONG, A. EVEREST-DASS, Erika LATTOVÁ, S. CAJIC, K. ALAGESAN, D. KOLARICH, T. KASALI, V. LINDO, Y. CHEN, K. GOSWAMI, B. GAU, R. AMUNUGAMA, R. JONES, C.J.M. STROOP, K. KATO, H. YAGI, S. KONDO, C.T. YUEN, A. HARAZONO, X.F. SHI, P.E. MAGNELLI, B.T. KASPER, L. MAHAL, D.J. HARVEY, R. FLAHERTY, P.M. RUDD, R. SALDOVA, E.S. HECHT, D.C. MUDDIMAN, J.C. KANG, P. BHOSKAR, D. MENARD, A. SAATI, C. MERLE, S. MAST, S. TEP, J. TRUONG, T. NISHIKAZE, S. SEKIYA, A. SHAFER, S. FUNAOKA, M. TOYODA, P. DE VREUGD, C. CARON, P. PRADHAN, N.C. TAN, Y. MECHREF, S. PATIL, J.S. ROHRER, R. CHAKRABARTI, D. DADKE, M. LAHORI, C.X. ZOU, C. CAIRO, B. REIZ, R.M. WHITTAL, C.B. LEBRILLA, L.R. WU, A. GUTTMAN, M. SZIGETI, B.G. KREMKOW, K.H. LEE, C. SIHLBOM, B. ADAMCZYK, C.S. JIN, N.G. KARLSSON, J. ORNROS, G. LARSON, J. NILSSON, B. MEYER, A. WIEGANDT, E. KOMATSU, H. PERREAULT, E.D. BODNAR, N. SAID, Y.N. FRANCOIS, E. LEIZE-WAGNER, S. MAIER, A. ZECK, A.J.R. HECK, Y. YANG, R. HASELBERG, Y.Q. YU, W. ALLEY, J.W. LEONE, H. YUAN a S.E. STEIN. NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods. MOLECULAR & CELLULAR PROTEOMICS. BETHESDA: AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC, 2020, roč. 19, č. 1, s. 11-30. ISSN 1535-9476. Dostupné z: https://dx.doi.org/10.1074/mcp.RA119.001677.
@article{1749836, author = {Leoz De, M.L.A. and Duewer, D.L. and Fung, A. and Liu, L. and Yau, H.K. and Potter, O. and Staples, G.O. and Furuki, K. and Frenkel, R. and Hu, Y.L. and Sosic, Z. and Zhang, P.Q. and Altmann, F. and GrunwaldandGrube, C. and Shao, C. and Zaia, J. and Evers, W. and Pengelley, S. and Suckau, D. and Wiechmann, A. and Resemann, A. and Jabs, W. and Beck, A. and Froehlich, J.W. and Huang, C.C. and Li, Y. and Liu, Y.M. and Sun, S.W. and Wang, Y.J. and Seo, Y. and An, H.J. and Reichardt, N.C. and Ruiz, J.E. and ArcherandHartmann, S. and Azadi, P. and Bell, L. and Lakos, Z. and An, Y.M. and Cipollo, J.F. and PucicandBakovic, M. and Stambuk, J. and Lauc, G. and Li, X. and Wang, X. and Bock, A. and Hennig, R. and Rapp, E. and Creskey, M. and Cyr, T.D. and Nakano, M. and Sugiyama, T. and Leung, P.K.A. and LinkandLenczowski, P. and Jaworek, J. and Yang, S. and Zhang, H. and Kelly, T. and Klapoetke, S. and Cao, R. and Kim, J.Y. and Lee, H.K. and Lee, J.Y. and Yoo, J.S. and Kim, S.R. and Suh, S.K. and de Haan, N. and Falck, D. and LageveenandKammeijer, G.S.M. and Wuhrer, M. and Emery, R.J. and Kozak, R.P. and Liew, L.P. and Royle, L. and Urbanowicz, P.A. and Packer, N.H. and Song, X.M. and EverestandDass, A. and Lattová, Erika and Cajic, S. and Alagesan, K. and Kolarich, D. and Kasali, T. and Lindo, V. and Chen, Y. and Goswami, K. and Gau, B. and Amunugama, R. and Jones, R. and Stroop, C.J.M. and Kato, K. and Yagi, H. and Kondo, S. and Yuen, C.T. and Harazono, A. and Shi, X.F. and Magnelli, P.E. and Kasper, B.T. and Mahal, L. and Harvey, D.J. and Flaherty, R. and Rudd, P.M. and Saldova, R. and Hecht, E.S. and Muddiman, D.C. and Kang, J.C. and Bhoskar, P. and Menard, D. and Saati, A. and Merle, C. and Mast, S. and Tep, S. and Truong, J. and Nishikaze, T. and Sekiya, S. and Shafer, A. and Funaoka, S. and Toyoda, M. and de Vreugd, P. and Caron, C. and Pradhan, P. and Tan, N.C. and Mechref, Y. and Patil, S. and Rohrer, J.S. and Chakrabarti, R. and Dadke, D. and Lahori, M. and Zou, C.X. and Cairo, C. and Reiz, B. and Whittal, R.M. and Lebrilla, C.B. and Wu, L.R. and Guttman, A. and Szigeti, M. and Kremkow, B.G. and Lee, K.H. and Sihlbom, C. and Adamczyk, B. and Jin, C.S. and Karlsson, N.G. and Ornros, J. and Larson, G. and Nilsson, J. and Meyer, B. and Wiegandt, A. and Komatsu, E. and Perreault, H. and Bodnar, E.D. and Said, N. and Francois, Y.N. and LeizeandWagner, E. and Maier, S. and Zeck, A. and Heck, A.J.R. and Yang, Y. and Haselberg, R. and Yu, Y.Q. and Alley, W. and Leone, J.W. and Yuan, H. and Stein, S.E.}, article_location = {BETHESDA}, article_number = {1}, doi = {http://dx.doi.org/10.1074/mcp.RA119.001677}, keywords = {Glycomics; mass spectrometry; fluorescence; glycosylation; glycoproteins; glycan; glycopeptide; interlaboratory study; NISTmAb; reference antibody}, language = {eng}, issn = {1535-9476}, journal = {MOLECULAR & CELLULAR PROTEOMICS}, title = {NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods}, url = {https://www.sciencedirect.com/science/article/pii/S1535947620300037?via%3Dihub}, volume = {19}, year = {2020} }
TY - JOUR ID - 1749836 AU - Leoz De, M.L.A. - Duewer, D.L. - Fung, A. - Liu, L. - Yau, H.K. - Potter, O. - Staples, G.O. - Furuki, K. - Frenkel, R. - Hu, Y.L. - Sosic, Z. - Zhang, P.Q. - Altmann, F. - Grunwald-Grube, C. - Shao, C. - Zaia, J. - Evers, W. - Pengelley, S. - Suckau, D. - Wiechmann, A. - Resemann, A. - Jabs, W. - Beck, A. - Froehlich, J.W. - Huang, C.C. - Li, Y. - Liu, Y.M. - Sun, S.W. - Wang, Y.J. - Seo, Y. - An, H.J. - Reichardt, N.C. - Ruiz, J.E. - Archer-Hartmann, S. - Azadi, P. - Bell, L. - Lakos, Z. - An, Y.M. - Cipollo, J.F. - Pucic-Bakovic, M. - Stambuk, J. - Lauc, G. - Li, X. - Wang, X. - Bock, A. - Hennig, R. - Rapp, E. - Creskey, M. - Cyr, T.D. - Nakano, M. - Sugiyama, T. - Leung, P.K.A. - Link-Lenczowski, P. - Jaworek, J. - Yang, S. - Zhang, H. - Kelly, T. - Klapoetke, S. - Cao, R. - Kim, J.Y. - Lee, H.K. - Lee, J.Y. - Yoo, J.S. - Kim, S.R. - Suh, S.K. - de Haan, N. - Falck, D. - Lageveen-Kammeijer, G.S.M. - Wuhrer, M. - Emery, R.J. - Kozak, R.P. - Liew, L.P. - Royle, L. - Urbanowicz, P.A. - Packer, N.H. - Song, X.M. - Everest-Dass, A. - Lattová, Erika - Cajic, S. - Alagesan, K. - Kolarich, D. - Kasali, T. - Lindo, V. - Chen, Y. - Goswami, K. - Gau, B. - Amunugama, R. - Jones, R. - Stroop, C.J.M. - Kato, K. - Yagi, H. - Kondo, S. - Yuen, C.T. - Harazono, A. - Shi, X.F. - Magnelli, P.E. - Kasper, B.T. - Mahal, L. - Harvey, D.J. - Flaherty, R. - Rudd, P.M. - Saldova, R. - Hecht, E.S. - Muddiman, D.C. - Kang, J.C. - Bhoskar, P. - Menard, D. - Saati, A. - Merle, C. - Mast, S. - Tep, S. - Truong, J. - Nishikaze, T. - Sekiya, S. - Shafer, A. - Funaoka, S. - Toyoda, M. - de Vreugd, P. - Caron, C. - Pradhan, P. - Tan, N.C. - Mechref, Y. - Patil, S. - Rohrer, J.S. - Chakrabarti, R. - Dadke, D. - Lahori, M. - Zou, C.X. - Cairo, C. - Reiz, B. - Whittal, R.M. - Lebrilla, C.B. - Wu, L.R. - Guttman, A. - Szigeti, M. - Kremkow, B.G. - Lee, K.H. - Sihlbom, C. - Adamczyk, B. - Jin, C.S. - Karlsson, N.G. - Ornros, J. - Larson, G. - Nilsson, J. - Meyer, B. - Wiegandt, A. - Komatsu, E. - Perreault, H. - Bodnar, E.D. - Said, N. - Francois, Y.N. - Leize-Wagner, E. - Maier, S. - Zeck, A. - Heck, A.J.R. - Yang, Y. - Haselberg, R. - Yu, Y.Q. - Alley, W. - Leone, J.W. - Yuan, H. - Stein, S.E. PY - 2020 TI - NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods JF - MOLECULAR & CELLULAR PROTEOMICS VL - 19 IS - 1 SP - 11-30 EP - 11-30 PB - AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC SN - 15359476 KW - Glycomics KW - mass spectrometry KW - fluorescence KW - glycosylation KW - glycoproteins KW - glycan KW - glycopeptide KW - interlaboratory study KW - NISTmAb KW - reference antibody UR - https://www.sciencedirect.com/science/article/pii/S1535947620300037?via%3Dihub N2 - A broad-based interlaboratory study of glycosylation profiles of a reference and modified IgG antibody involving 103 reports from 76 laboratories. Glycosylation is a topic of intense current interest in the development of biopharmaceuticals because it is related to drug safety and efficacy. This work describes results of an interlaboratory study on the glycosylation of the Primary Sample (PS) of NISTmAb, a monoclonal antibody reference material. Seventy-six laboratories from industry, university, research, government, and hospital sectors in Europe, North America, Asia, and Australia submitted a total of 103 reports on glycan distributions. The principal objective of this study was to report and compare results for the full range of analytical methods presently used in the glycosylation analysis of mAbs. Therefore, participation was unrestricted, with laboratories choosing their own measurement techniques. Protein glycosylation was determined in various ways, including at the level of intact mAb, protein fragments, glycopeptides, or released glycans, using a wide variety of methods for derivatization, separation, identification, and quantification. Consequently, the diversity of results was enormous, with the number of glycan compositions identified by each laboratory ranging from 4 to 48. In total, one hundred sixteen glycan compositions were reported, of which 57 compositions could be assigned consensus abundance values. These consensus medians provide community-derived values for NISTmAb PS. Agreement with the consensus medians did not depend on the specific method or laboratory type. The study provides a view of the current state-of-the-art for biologic glycosylation measurement and suggests a clear need for harmonization of glycosylation analysis methods. ER -
LEOZ DE, M.L.A., D.L. DUEWER, A. FUNG, L. LIU, H.K. YAU, O. POTTER, G.O. STAPLES, K. FURUKI, R. FRENKEL, Y.L. HU, Z. SOSIC, P.Q. ZHANG, F. ALTMANN, C. GRUNWALD-GRUBE, C. SHAO, J. ZAIA, W. EVERS, S. PENGELLEY, D. SUCKAU, A. WIECHMANN, A. RESEMANN, W. JABS, A. BECK, J.W. FROEHLICH, C.C. HUANG, Y. LI, Y.M. LIU, S.W. SUN, Y.J. WANG, Y. SEO, H.J. AN, N.C. REICHARDT, J.E. RUIZ, S. ARCHER-HARTMANN, P. AZADI, L. BELL, Z. LAKOS, Y.M. AN, J.F. CIPOLLO, M. PUCIC-BAKOVIC, J. STAMBUK, G. LAUC, X. LI, X. WANG, A. BOCK, R. HENNIG, E. RAPP, M. CRESKEY, T.D. CYR, M. NAKANO, T. SUGIYAMA, P.K.A. LEUNG, P. LINK-LENCZOWSKI, J. JAWOREK, S. YANG, H. ZHANG, T. KELLY, S. KLAPOETKE, R. CAO, J.Y. KIM, H.K. LEE, J.Y. LEE, J.S. YOO, S.R. KIM, S.K. SUH, N. DE HAAN, D. FALCK, G.S.M. LAGEVEEN-KAMMEIJER, M. WUHRER, R.J. EMERY, R.P. KOZAK, L.P. LIEW, L. ROYLE, P.A. URBANOWICZ, N.H. PACKER, X.M. SONG, A. EVEREST-DASS, Erika LATTOVÁ, S. CAJIC, K. ALAGESAN, D. KOLARICH, T. KASALI, V. LINDO, Y. CHEN, K. GOSWAMI, B. GAU, R. AMUNUGAMA, R. JONES, C.J.M. STROOP, K. KATO, H. YAGI, S. KONDO, C.T. YUEN, A. HARAZONO, X.F. SHI, P.E. MAGNELLI, B.T. KASPER, L. MAHAL, D.J. HARVEY, R. FLAHERTY, P.M. RUDD, R. SALDOVA, E.S. HECHT, D.C. MUDDIMAN, J.C. KANG, P. BHOSKAR, D. MENARD, A. SAATI, C. MERLE, S. MAST, S. TEP, J. TRUONG, T. NISHIKAZE, S. SEKIYA, A. SHAFER, S. FUNAOKA, M. TOYODA, P. DE VREUGD, C. CARON, P. PRADHAN, N.C. TAN, Y. MECHREF, S. PATIL, J.S. ROHRER, R. CHAKRABARTI, D. DADKE, M. LAHORI, C.X. ZOU, C. CAIRO, B. REIZ, R.M. WHITTAL, C.B. LEBRILLA, L.R. WU, A. GUTTMAN, M. SZIGETI, B.G. KREMKOW, K.H. LEE, C. SIHLBOM, B. ADAMCZYK, C.S. JIN, N.G. KARLSSON, J. ORNROS, G. LARSON, J. NILSSON, B. MEYER, A. WIEGANDT, E. KOMATSU, H. PERREAULT, E.D. BODNAR, N. SAID, Y.N. FRANCOIS, E. LEIZE-WAGNER, S. MAIER, A. ZECK, A.J.R. HECK, Y. YANG, R. HASELBERG, Y.Q. YU, W. ALLEY, J.W. LEONE, H. YUAN a S.E. STEIN. NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods. \textit{MOLECULAR \&{}amp; CELLULAR PROTEOMICS}. BETHESDA: AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC, 2020, roč.~19, č.~1, s.~11-30. ISSN~1535-9476. Dostupné z: https://dx.doi.org/10.1074/mcp.RA119.001677.