Evaluation of the impact of antibody fragments on aggregation of intact molecules via size exclusion chromatography coupled with native mass spectrometry

Autor: Jing Xu, John E. Coughlin, Malgorzata Szyjka, Serene Jabary, Sonal Saluja, Zoran Sosic, Yunqiu Chen, Chong-Feng Xu

Publikováno v: mAbs, Vol 16, Iss 1 (2024)

ABSTRACTAggregates are recognized as one of the most critical product-related impurities in monoclonal antibody (mAb)-based therapeutics due to their negative impact on the stability and safety of the drugs. So far, investigational efforts have prima

Externí odkaz: https://doaj.org/article/8a4dd72d29084788975e90ab944ead49

ACUVRA: Anion-Exchange Chromatography UV-Ratio Analysis-A QC-Friendly Method for Monitoring Adeno-Associated Virus Empty Capsid Content To Support Process Development and GMP Release Testing

Autor: Ruth Frenkel, Dana Tribby, Boris Boumajny, Nicholas Larson, Matthew Sampson, Christopher Barney, Svetlana Bergelson, Zoran Sosic, Bernice Yeung

Publikováno v: The AAPS journalReferences. 25(1)

The genome content of adeno-associated virus (AAV) vectors is critical to the safety and potency of AAV-based gene therapy products. Empty capsids are considered a product-related impurity and a critical quality attribute (CQA) of the drug product, t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dc63ef02717cc89ac12577413d8959dd
https://pubmed.ncbi.nlm.nih.gov/36414847

Development and validation of a platform reduced intact mass method for process monitoring of monoclonal antibody glycosylation during routine manufacturing

Autor: Pamela Feng, Michael Schilling, Zoran Sosic, Stacey L. Traviglia

Publikováno v: Bioengineered, Vol 11, Iss 1, Pp 1301-1312 (2020)
Bioengineered
article-version (VoR) Version of Record

N-linked glycosylation is a primary source of heterogeneity associated with recombinant monoclonal antibodies and plays a key role in a myriad of drug properties associated with biological function. The glycosylation profile of recombinant monoclonal

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3265361c6b49fbe5d04f89d2d47b65f3
https://doaj.org/article/34f129fa1f374f73b24da283490e832a

NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies

Autor: Miyako Nakano, Alena Wiegandt, Yunli Hu, Viv Lindo, Paulina A. Urbanowicz, Zsuzsanna Lakos, Cassie Caron, Song Klapoetke, Niels Christian Reichardt, Niclas Chiang Tan, Sandra Maier, Rene Hennig, Marton Szigeti, Ju Yeon Lee, Ying Qing Yu, Gregory O. Staples, Sachin Patil, Jolanta Jaworek, Waltraud Evers, Benjamin G. Kremkow, Youngsuk Seo, Kathirvel Alagesan, Yuetian Chen, Gordan Lauc, David L. Duewer, Yang Yang, Daniele Menard, Hyun Joo An, Tim Kelly, Stephen E. Stein, Joseph W. Leone, Anja Wiechmann, Ravi Amunugama, Peng George Wang, Clemens Grunwald-Grube, Maria Lorna A. De Leoz, Göran Larson, Rob Haselberg, Samanta Cajic, Stephanie A. Archer-Hartmann, Maja Pučić-Baković, Edward D. Bodnar, Pauline M. Rudd, Anja Resemann, Daniel Kolarich, Akira Harazono, Jeffrey S. Rohrer, Juan Echevarria Ruiz, Stuart Pengelley, Jong Shin Yoo, Arun V. Everest-Dass, Nicolle H. Packer, Steven W. Mast, William R. Alley, Erika Lattová, Anne Zeck, Corné J.M. Stroop, Radoslaw P. Kozak, Chun Shao, Alain Beck, Joseph Zaia, Erdmann Rapp, Lily Liu, Jennie Truong, Yaojun Wang, Christopher W. Cairo, Roisin O'Flaherty, Radka Saldova, Kudrat Goswami, Emy Komatsu, Jessica Örnros, Taiki Sugiyama, Prachi Bhoskar, Pralima Pradhan, Carlito B. Lebrilla, András Guttman, Christine Merle, Brian Kasper, Oscar G. Potter, Soo Kyung Suh, Li Phing Liew, Ranjan Chakrabarti, Terry D. Cyr, Sohei Funaoka, Masaaki Toyoda, Pui King Amy Leung, Toyin Kasali, Jerko Štambuk, Yanming An, Wolfgang Jabs, Bernd Meyer, Chunxia Zou, John F. Cipollo, Sa Rang Kim, Aaron Shafer, Randy M. Whittal, Jichao Kang, Albert J. R. Heck, Yehia Mechref, Hoi Kei Yau, Guinevere S. M. Lageveen-Kammeijer, Shiwei Sun, Kenichiro Furuki, Richard B. Jones, Béla Reiz, Niclas G. Karlsson, Mohammedazam Lahori, Xu Li, Barbara Adamczyk, Rui Cao, Lauren Wu, Koichi Kato, Detlev Suckau, Paweł Link-Lenczowski, Kelvin H. Lee, Xiaomin Song, Noortje de Haan, Ruth Frenkel, Adam Fung, Friedrich Altmann, Manfred Wuhrer, David Falck, Andreas Bock, Paula Magnelli, Brian Gau, Sachiko Kondo, Robert J. Emery, Chunsheng Jin, Louise Royle, David C. Muddiman, Hélène Perreault, John W. Froehlich, Disha Dadke, Peiqing Zhang, Lara K. Mahal, Takashi Nishikaze, Andrew Saati, Chuncui Huang, Hui Zhang, Carina Sihlbom, Parastoo Azadi, Jonas Nilsson, Yaming Liu, Yannis-Nicolas François, Nassur Said, Jin Young Kim, C. T. Yuen, Shuang Yang, Emmanuelle Leize-Wagner, David Harvey, Xiaofeng Shi, Yan Li, Hirokazu Yagi, Zoran Sosic, Elizabeth M. Hecht, Hua Yuan, Marybeth Creskey, Hyun Kyoung Lee, Sadanori Sekiya, Peter de Vreugd, Len Bell, Sam Tep

Publikováno v: De Leoz, M L A, Duewer, D L, Fung, A, Liu, L, Yau, H K, Potter, O, Staples, G O, Furuki, K, Frenkel, R, Hu, Y, Sosic, Z, Zhang, P, Altmann, F, Gru Nwald-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, Li, Y, Liu, Y, Sun, S, Wang, Y, Seo, Y, An, H J, Reichardt, N C, Ruiz, J E, Archer-Hartmann, S, Azadi, P, Bell, L, Lakos, Z, An, Y, Cipollo, J F, Pucic-Bakovic, M, Štambuk, J, Lauc, G, Li, X, Wang, P G, 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, Everest-Dass, A, Lattová, E, 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, Magnelli, P E, Kasper, B T, Mahal, L, Harvey, D J, O'Flaherty, R, Rudd, P M, Saldova, R, Hecht, E S, Muddiman, D C, Kang, J, 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, Cairo, C, Reiz, B, Whittal, R M, Lebrilla, C B, Wu, L, Guttman, A, Szigeti, M, Kremkow, B G, Lee, K H, Sihlbom, C, Adamczyk, B, Jin, C, Karlsson, N G, Örnros, 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 2020, ' NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies : Comparison of Results from Diverse Analytical Methods ', MCP : Molecular & cellular proteomics, vol. 19, no. 1, pp. 11-30 . https://doi.org/10.1074/mcp.RA119.001677
Molecular and Cellular Proteomics, 19(1), 11-30. AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
MCP : Molecular & cellular proteomics, 19(1), 11-30. American Society for Biochemistry and Molecular Biology Inc.
Molecular & Cellular Proteomics
Molecular & Cellular Proteomics, 19(1), 11-30. AMER SOC BIOCHEMISTRY MOLECULAR BIOLOGY INC
Molecular and Cellular Proteomics
Molecular and Cellular Proteomics, American Society for Biochemistry and Molecular Biology, 2019, mcp.RA119.001677. ⟨10.1074/mcp.RA119.001677⟩
Molecular and Cellular Proteomics, 19(1), 11. American Society for Biochemistry and Molecular Biology Inc.
Molecular & Cellular Proteomics : MCP

A broad-based interlaboratory study of glycosylation profiles of a reference and modified IgG antibody involving 103 reports from 76 laboratories.
Graphical Abstract Highlights A broad-based interlaboratory study of the glycosylation of a refere

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4214e7f722323aeb909a6ec71f3d6bbd
https://doi.org/10.1074/mcp.RA119.001677

Application of a label-free and domain-specific free thiol method in monoclonal antibody characterization

Autor: Yi Pu, Yunqiu Chen, Li Zang, Chong-Feng Xu, Zoran Sosic, Tyler Carlage, Tai Nguyen

Publikováno v: Journal of Chromatography B. :93-99

Characterization of free thiol variants in antibody therapeutics is important for biopharmaceutical development, as the presence of free thiols may have an impact on aggregate formation, structural and thermal stability, as well as antigen-binding po

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4e629b5ec749c52c111d5d9870851cb1
https://doi.org/10.1016/j.jchromb.2019.03.032