Determination of ultra-trace metal-protein interactions in co-formulated monoclonal antibody drug product by SEC-ICP-MS

Autor: Laurence Whitty-Léveillé, Zachary L. VanAernum, Jorge Alexander Pavon, Christa Murphy, Katie Neal, William Forest, Xinliu Gao, Wendy Zhong, Douglas D. Richardson, Hillary A. Schuessler

Publikováno v: mAbs, Vol 15, Iss 1 (2023)

ABSTRACTTransition metals can be introduced in therapeutic protein drugs at various steps of the manufacturing process (e.g. manufacturing raw materials, formulation, storage), and can cause a variety of modifications on the protein. These modificati

Externí odkaz: https://doaj.org/article/e85c42b380f64a3e848c113be5ed8715

Automated Data Generation for Raman Spectroscopy Calibrations in Multi-Parallel Mini Bioreactors

Autor: Alexander Graf, Angus Woodhams, Michael Nelson, Douglas D. Richardson, Steven M. Short, Mark Brower, Marek Hoehse

Publikováno v: Sensors, Vol 22, Iss 9, p 3397 (2022)

Raman spectroscopy is an analytical technology for the simultaneous measurement of important process parameters, such as concentrations of nutrients, metabolites, and product titer in mammalian cell culture. The majority of published Raman studies ha

Externí odkaz: https://doaj.org/article/7a900191ccdc414da3861215fc0f76a4

Advancing Structure Characterization of PS-80 by Charge-Reduced Mass Spectrometry and Software-Assisted Composition Analysis

Autor: Simon Letarte, Li-Kang Zhang, Douglas D. Richardson, Rong-Sheng Yang, Damon Barbacci, Nick DeGraan-Weber, David R. Bush

Publikováno v: Journal of Pharmaceutical Sciences. 111:314-322

The commercially available Polysorbate 80 (PS-80) is a highly heterogeneous product. It is a complex and structurally diverse mixture consisting of polymeric species containing polyoxyethylenes (POEs), fatty acid esters, with/or without a carbohydrat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::091963f52c0b150a977b600885889a68
https://doi.org/10.1016/j.xphs.2021.08.036

In situ real time monitoring of emulsification and homogenization processes for vaccine adjuvants

Autor: Nicole M. Ralbovsky, Randal J. Soukup, Justin P. Lomont, Mackenzie L. Lauro, Amanda Gulasarian, Anumita Saha-Shah, Michael A. Winters, Douglas D. Richardson, Sheng-Ching Wang, Ian Mangion, Joseph P. Smith

Publikováno v: The Analyst. 147:378-386

Process analytical technology was used to monitor formation of a stable emulsion product, with results providing improved understanding of emulsion-based vaccine adjuvant formation processes.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::3464034c66f72fd9bf2e651c423534a5
https://doi.org/10.1039/d1an01797g

New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study

Autor: Irina Perdivara, Ben Niu, Kim F. Haselmann, St John Skilton, Anthony Leone, Gregory O. Staples, Carsten P. Sønksen, Helena Maria Barysz, Andrew Hanneman, Chun Shao, Rebecca Scott, Anders Lund, Carly Daniels, Michael Jahn, Da Ren, Nunzio Sepe, K. Ilker Sen, Zoran Sosic, David Ripley, Jing Zhen, Margo Wilson, Melissa Alvarez, John G Hoogerheide, Xinbi Li, Harini Kaluarachchi, Josh Woods, Wenqin Ni, Albrecht Gruhler, Keith A. Johnson, Arnd Brandenburg, Kristen Nields, Michelle Busch, Douglas D. Richardson, Yan Wang, Ahmet Cansizoglu, Xiaoxiao Li, Greg W Adams, Simon Letarte, Joe Shambaugh, Hua Yuan, Trina Mouchahoir, Tom Robinson, Xiaoshi Wang, Nancy S. Nightlinger, Alexander Julian Veach, Chris Chumsae, Eric Carlson, Dongdong Wang, Sean Shen, Jing Fang, Wei Wu, Stefano Gotta, Justin B. Sperry, Hirsh Nanda, X. Christopher Yu, Sibylle Heidelberger, Bhumit A. Patel, Jihong Wang, Sean McCarthy, Himakshi Patel, Thomas N. Krogh, Hunter Walker, Olga V. Friese, Daniela Tizabi, Yali Lu, Kristin Boggio, Ernest L. Maynard, Rich Rogers, Ying Zhou, Nick DeGraan-Weber, John E. Schiel, Weibin Chen, Jason C. Rouse, Li Tao, Thomas W. Powers, John Kim, Xu Guo, Bo Yan, Gabriella Leo, Ying Zhang, Oleg V. Borisov, Ying Qing Yu, Martha Stapels, Wael Yared, Yan-Hui Liu, Alan Heckert, Sarah Rogstad, Li Zang, Aaron Ammerman, Li Cao, Benjamin J. Place, Richard Ludwig, Anton V. Manuilov, Andrew Mahan, Andrew Dawdy, Yi Wang, Brian Schmidt, Peiran Liu

Publikováno v: Journal of the American Society for Mass Spectrometry. 32:913-928

The Multi-Attribute Method (MAM) Consortium was initially formed as a venue to harmonize best practices, share experiences, and generate innovative methodologies to facilitate widespread integration of the MAM platform, which is an emerging ultra-hig

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4baf4a0ab2df01bdb011465e0f168239
https://doi.org/10.1021/jasms.0c00415