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Displaying 1 - 25 of 66

Humanized Monoclonal Antibody IgG1k, NISTmAb RM 8671 Summary of 5 Year Stability Verification (5YSV)

March 31, 2023
Author(s)
Katharina Yandrofski, John E. Schiel, Trina Mouchahoir, Srivalli Telikepalli, N. Alan Heckert, Dean C. Ripple, Paul C. DeRose, Karen W. Phinney, John Marino
NISTmAb RM 8671 is an IgG1κ monoclonal antibody that has been extensively characterized and released as the first of its kind biopharmaceutical reference material in 2016. This material was intended primarily for use in evaluating the performance of

Biomanufacturing Readiness Levels (BRL) - A Shared Vocabulary for Biomanufacturing Technology Development and Commercialization

September 7, 2022
Author(s)
John E. Schiel, Kelley Rogers, Sandeep Kedia, Jeffery Baker, Ruben Carbonell, Kelvin Lee, Christopher Roberts, John Erickson, Gene Schaefer, Stephanie Pluschkell
The Manufacturing Readiness Levels (MRLs) developed by the Department of Defense (DoD), are well established tools for describing the maturity of new technologies resulting from government sponsored Research and Development (R&D) programs, from the concept

Interlaboratory Attribute Analytics Metrics from the MAM Consortium Round Robin Study

August 26, 2022
Author(s)
Trina Mouchahoir, John E. Schiel, Rich Rogers, N. Alan Heckert, Benjamin Place, Aaron Ammerman, Xiaoxiao Li, Tom Robinson, Brian Schmidt, Chris M. Chumsae, Xinbi Li, Anton V. Manuilov, Bo Yan, Gregory O. Staples, Da Ren, Alexander J. Veach, Dongdong Wang, Wael Yared, Zoran Sosic, Yan Wang, Li Zang, Anthony M. Leone, Peiran Liu, Richard Ludwig, Li Tao, Wei Wu, Ahmet Cansizoglu, Andrew Hanneman, Greg W. Adams, Irina Perdivara, Hunter Walker, Margo Wilson, Arnd Brandenburg, Nick DeGraan-Weber, Stefano Gotta, Joe Shambaugh, Melissa Alvarez, X. Christopher Yu, Li Cao, Chun Shao, Andrew Mahan, Hirsh Nanda, Kristen Nields, Nancy Nightlinger, Ben Niu, Jihong Wang, Wei Xu, Gabriella Leo, Nunzio Sepe, Yan-Hui Liu, Bhumit A. Patel, Douglas Richardson, Yi Wang, Daniela Tizabi, Oleg V. Borisov, Yali Lu, Ernest L. Maynard, Albrecht Gruhler, Kim F. Haselmann, Thomas N. Krogh, Carsten P. Sonksen, Simon Letarte, Sean Shen, Kristin Boggio, Keith Johnson, Wenqin Ni, Himakshi Patel, David Ripley, Jason C. Rouse, Ying Zhang, Carly Daniels, Andrew Dawdy, Olga Friese, Thomas W. Powers, Justin B. Sperry, Josh Woods, Eric Carlson, K. Ilker Sen, St John Skilton, Michelle Busch, Anders Lund, Martha Stapels, Xu Guo, Sibylle Heidelberger, Harini Kaluarachchi, Sean McCarthy, John Kim, Jing Zhen, Ying Zhou, Sarah Rogstad, Xiaoshi Wang, Jing Fang, Weibin Chen, Ying Qing Yu, John G. Hoogerheide, Rebecca Scott, Hua Yuan
The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process development and quality control (QC) for protein therapeutics. MAM is rooted in traditional peptide

Interlaboratory Studies using the NISTmAb to Advance Biopharmaceutical Structural Analytics

May 5, 2022
Author(s)
Katharina Yandrofski, Trina Mouchahoir, M. Lorna De Leoz, David L. Duewer, Jeffrey W. Hudgens, Kyle Anderson, Luke Arbogast, Frank Delaglio, Robert Brinson, John Marino, Karen W. Phinney, Michael J. Tarlov, John E. Schiel
Biopharmaceuticals such as monoclonal antibodies are required to be rigorously characterized using a wide range of analytical methods. Various material properties must be characterized and well controlled to assure that clinically relevant features and

Metrological Tools for the Reference Materials and Reference Instruments of the NIST Material Measurement Laboratory

September 16, 2021
Author(s)
Carlos R. Beauchamp, Johanna Camara, Jennifer Carney, Steven J. Choquette, Kenneth D. Cole, Paul C. DeRose, David L. Duewer, Michael Epstein, Margaret Kline, Katrice Lippa, Enrico Lucon, John L. Molloy, Michael Nelson, Karen W. Phinney, Maria Polakoski, Antonio Possolo, Lane C. Sander, John E. Schiel, Katherine E. Sharpless, Michael R. Winchester, Donald Windover
The National Institute of Standards and Technology (NIST), formerly the National Bureau of Standards, was established by the U.S. Congress in 1901 and charged with establishing a measurement foundation to facilitate U.S. and international commerce. NIST

Site-Specific Glycan-Conjugated NISTmAb Antibody Drug Conjugate Standards

July 6, 2021
Author(s)
Brian Agnew, Shanhua Lin, Robert Aggeler, John E. Schiel, Trina Mouchahoir
Antibody drug conjugates (ADCs) represent a rapidly growing modality for the treatment of numerous oncology indications. The complexity of analytical characterization method development is increased due to the potential for synthetic intermediates and

New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study

March 12, 2021
Author(s)
Catherine A. Mouchahoir, John E. Schiel, Rich Rogers, N. Alan Heckert, Benjamin Place, Aaron Ammerman, Xiaoxiao Li, Tom Robinson, Brian Schmidt, Chris M. Chumsae, Xinbi Li, Anton V. Manuilov, Bo Yan, Gregory O. Staples, Da Ren, Alexander J. Veach, Dongdong Wang, Wael Yared, Zoran Sosic, Yan Wang, Li Zang, Anthony M. Leone, Peiran Liu, Richard Ludwig, Li Tao, Wei Wu, Ahmet Cansizoglu, Andrew Hanneman, Greg W. Adams, Irina Perdivara, Hunter Walker, Margo Wilson, Arnd Brandenburg, Nick DeGraan-Weber, Stefano Gotta, Joe Shambaugh, Melissa Alvarez, X. Christopher Yu, Li Cao, Chun Shao, Andrew Mahan, Hirsh Nanda, Kristen Nields, Nancy Nightlinger, Helena Maria Barysz, Michael Jahn, Ben Niu, Jihong Wang, Gabriella Leo, Nunzio Sepe, Yan-Hui Liu, Bhumit A. Patel, Douglas Richardson, Yi Wang, Daniela Tizabi, Oleg V. Borisov, Yali Lu, Ernest L. Maynard, Albrecht Gruhler, Kim F. Haselmann, Thomas N. Krogh, Carsten P. Sonksen, Simon Letarte, Sean Shen, Kristin Boggio, Keith Johnson, Wenqin Ni, Hamakshi Patel, David Ripley, Jason C. Rouse, Ying Zhang, Carly Daniels, Andrew Dawdy, Olga Friese, Thomas W. Powers, Justin B. Sperry, Josh Woods, Eric Carlson, K. Ilker Sen, St John Skilton, Michelle Busch, Anders Lund, Martha Stapels, Xu Guo, Sibylle Heidelberger, Harini Kaluarachchi, Sean McCarthy, John Kim, Jing Zhen, Ying Zhou, Sarah Rogstad, Xiaoshi Wang, Jing Fang, Weibin Chen, Ying Qing Yu, John G. Hoogerheide, Rebecca Scott, Hua Yuan
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-high

Cyberbiosecurity for biopharmaceutical products

February 8, 2021
Author(s)
Elizabeth Strychalski, Jennifer Mantla, Jayan Rammohan, Eugenia Romantseva, Reid D'Amico, Joel Welch, Leah R. Kauffman, James McCarthy, John E. Schiel, Jeffrey Baker, Kelley Rogers, Kelvin Lee

Highland games: A benchmarking exercise in predicting biophysical and drug properties of monoclonal antibodies from amino acid sequences

April 6, 2020
Author(s)
John E. Schiel, Coffman Jon, Bruno Marques, Griesbach Jan, Ambrose Williams, Gisela Ferreira, Rushd Khalaf, David Roush, Charles Haynes
Biopharmaceutical product and process development does not yet take advantage of predictive computational modeling to nearly the degree seen in industries based on smaller molecules. To assess and advance progress in this area, spirited coopetition was

NIST Spectroscopic Measurement Standards

May 1, 2018
Author(s)
Paul C. DeRose, Kenneth D. Cole, Aaron Urbas, Steven J. Choquette, Evelyn Solis, Erica V. Stein, John E. Schiel, Brian Lang, Hua-Jun He
Ultraviolet (UV) absorbance measurements provide a rapid and reliable method to determine protein concentrations. The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082as a pathlength standard for UV