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ACS symposium series, 1201

Determination of the NISTmAb Primary Structure / Formolo, Trina, Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States; Ly, Mellisa, Mass Spectrometry and Biophysical Characterization, Analytical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc., Andover, Massachusetts 01810, United States; Levy, Michaella, Center for Drug Evaluation and Research, Office of Testing and Research, Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, Saint Louis, Missouri 63110, United States; Kilpatrick, Lisa, Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States; Lute, Scott, Center for Drug Evaluation and Research, Office of Biotechnology Products, Division of Monoclonal Antibodies, U.S Food and Drug Administration, Silver Spring, Maryland 20993, United States; Phinney, Karen, Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States; Marzilli, Lisa, Mass Spectrometry and Biophysical Characterization, Analytical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc., Andover, Massachusetts 01810, United States; Brorson, Kurt, Center for Drug Evaluation and Research, Office of Biotechnology Products, Division of Monoclonal Antibodies, U.S Food and Drug Administration, Silver Spring, Maryland 20993, United States; Boyne, Michael, Center for Drug Evaluation and Research, Office of Testing and Research, Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, Saint Louis, Missouri 63110, United States; Davis, Darryl, Janssen Research and Development, LLC, Spring House, Pennsylvania 19002, United States; Schiel, John, Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch001

Sequence Variants and Sequence Variant Analysis in Biotherapeutic Proteins / Borisov, Oleg V., Novavax, Inc., Gaithersburg, Maryland 20878, United States; Alvarez, Melissa, Roche Group Member, Genentech, Inc., South San Francisco, California 94080, United States; Carroll, James A., Pfizer Worldwide Research & Development, Chesterfield, Missouri 63017, United States; Brown, Paul W., Pfizer Worldwide Research & Development, Chesterfield, Missouri 63017, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch002

Structural Elucidation of Post-Translational Modifications in Monoclonal Antibodies / Li, Wenzhou, Amgen Inc., Thousand Oaks, California 91320, United States; Kerwin, James L., Sanovas Inc., Sausalito, California 94965, United States; Schiel, John, Analytical Chemistry Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States; Formolo, Trina, Analytical Chemistry Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States; Davis, Darryl, Janssen Research and Development, LLC, Spring House, Pennsylvania 19477, United States; Mahan, Andrew, Janssen Research and Development, LLC, Spring House, Pennsylvania 19477, United States; Benchaar, Sabrina A., Amgen Inc., Thousand Oaks, California 91320, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch003

Orthogonal Technologies for NISTmAb N-Glycan Structure Elucidation and Quantitation / Prien, Justin M., Analytical Sciences, Amgen Inc., 40 Technology Way, West Greenwich, Rhode Island 02817, United States; Stöckmann, Henning, NIBRT GlycoScience Group, NIBRT (The National Institute for Bioprocessing Research and Training), Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland; Albrecht, Simone, NIBRT GlycoScience Group, NIBRT (The National Institute for Bioprocessing Research and Training), Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland; Martin, Silvia M., NIBRT GlycoScience Group, NIBRT (The National Institute for Bioprocessing Research and Training), Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland; Varatta, Matthew, Analytical Sciences, Amgen Inc., 40 Technology Way, West Greenwich, Rhode Island 02817, United States; Furtado, Marsha, Analytical Sciences, Amgen Inc., 40 Technology Way, West Greenwich, Rhode Island 02817, United States; Hosselet, Stephen, Analytical Sciences, Amgen Inc., 40 Technology Way, West Greenwich, Rhode Island 02817, United States; Wang, Meiyao, Biomolecular Measurement Division, National Institute of Standards and Technology, 100 Bureau Dr., Stop 8314, Gaithersburg, Maryland 20899, United States; Formolo, Trina, Biomolecular Measurement Division, National Institute of Standards and Technology, 100 Bureau Dr., Stop 8314, Gaithersburg, Maryland 20899, United States; Rudd, Pauline M., NIBRT GlycoScience Group, NIBRT (The National Institute for Bioprocessing Research and Training), Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland; Schiel, John E., Biomolecular Measurement Division, National Institute of Standards and Technology, 100 Bureau Dr., Stop 8314, Gaithersburg, Maryland 20899, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch004

Separation Methods and Orthogonal Techniques / Michels, David A., Department of Protein Analytical Chemistry, Genentech, South San Francisco, California 94080, United States; Ip, Anna Y., Department of Process and Product Development, Amgen Inc., Thousand Oaks, California 91361, United States; Dillon, Thomas M., Department of Process and Product Development, Amgen Inc., Thousand Oaks, California 91361, United States; Brorson, Kurt, Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20903, United States; Lute, Scott, Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20903, United States; Chavez, Brittany, Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20903, United States; Prentice, Ken M., Department of Process and Product Development, Amgen Inc., Seattle, Washington 98119, United States; Brady, Lowell J., Department of Process and Product Development, Amgen Inc., Seattle, Washington 98119, United States; Miller, Karen J., Global Analytical Sciences, Amgen Inc., Thousand Oaks, California 91320, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch005

Biophysical Techniques for Characterizing the Higher Order Structure and Interactions of Monoclonal Antibodies / Gokarn, Yatin, Institute of Chemical Technology, Mumbai, India; Agarwal, Sanjeev, Institute of Chemical Technology, Mumbai, India; Arthur, Kelly, Amgen Inc., Thousand Oaks, California 91320, United States; Bepperling, Alexander, Hexal AG, Oberhaching, Germany; Day, Eric S., Genentech, South San Francisco, California 94080, United States; Filoti, Dana, University of New Hampshire, Durham, New Hampshire 03824, United States; Greene, Daniel G., University of Delaware, Newark, Delaware 19716, United States; Hayes, David, Boehringer Ingelheim, Ridgebury, Connecticut 06877, United States; Kroe-Barrett, Rachel, Boehringer Ingelheim, Ridgebury, Connecticut 06877, United States; Laue, Thomas, University of New Hampshire, Durham, New Hampshire 03824, United States; Lin, Jasper, Genentech, South San Francisco, California 94080, United States; McGarry, Brian, Genentech, South San Francisco, California 94080, United States; Razinkov, Vladimir, Amgen Inc., Thousand Oaks, California 91320, United States; Singh, Sanjaya, Boehringer Ingelheim, Ridgebury, Connecticut 06877, United States; Taing, Rosalynn, Genentech, South San Francisco, California 94080, United States; Venkataramani, Sathyadevi, Boehringer Ingelheim, Ridgebury, Connecticut 06877, United States; Weiss, William, Eli Lilly, Indianapolis, Indiana 46221, United States; Yang, Danlin, Boehringer Ingelheim, Ridgebury, Connecticut 06877, United States; Zarraga, Isidro E., Genentech, South San Francisco, California 94080, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch006

Developability Assessment of a Proposed NIST Monoclonal Antibody / Saro, Dorina, Analytical Discovery Group, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC, Spring House, Pennsylvania 19477, United States; Baker, Audrey, Analytical Discovery Group, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC, Spring House, Pennsylvania 19477, United States; Hepler, Robert, Analytical Discovery Group, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC, Spring House, Pennsylvania 19477, United States; Spencer, Stacey, Analytical Discovery Group, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC, Spring House, Pennsylvania 19477, United States; Bruce, Rick, Drug Product Development, Parentals and Liquids Formulation, Janssen Research & Development, LLC, Malvern, Pennsylvania 19355, United States; LaBrenz, Steven, Drug Product Development, Parentals and Liquids Formulation, Janssen Research & Development, LLC, Malvern, Pennsylvania 19355, United States; Chiu, Mark, Analytical Discovery Group, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC, Spring House, Pennsylvania 19477, United States; Davis, Darryl, Analytical Discovery Group, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC, Spring House, Pennsylvania 19477, United States; Lang, Steven E., Analytical Discovery Group, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC, Spring House, Pennsylvania 19477, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch007

Protein Particles (0.1 µm to 100 µm) / Ripple, Dean C., Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, Maryland, 20899, United States; Narhi, Linda O., Research and Development, Amgen Inc., Thousand Oaks, California 91320, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch008

Analytical Methods for the Measurement of Host Cell Proteins and Other Process-Related Impurities / Prakash, Kesh, Emergent BioSolutions, 300 Professional Drive, Gaithersburg, Maryland 20879, United States; Chen, Weibin, Waters Corporation, 34 Maple Street, Milford, Massachusetts 01757, United States / http://dx.doi.org/10.1021/bk-2015-1201.ch009

Appendix / http://dx.doi.org/10.1021/bk-2015-1201.ot002

Editors' Biographies / http://dx.doi.org/10.1021/bk-2015-1201.ot001

Immunoglobulins > Therapeutic use.

Monoclonal antibodies > Structure.

Biological products > Therapeutic use > Analysis.

Monoclonal antibodies > Modification > Analysis.

Proteins > Molecular aspects > Measurement.

Contamination (Technology) > Analysis.

Antibodies, Monoclonal.

Immunoglobulins - therapeutic use.

Sequence Analysis, Protein.

Biological Therapy.

Protein Processing, Post-Translational.

Polysaccharides - analysis.

Biophysical Phenomena.

Proteins - analysis.

American Chemical Society, sponsoring body.