State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

The NISTmAb Case Study

Edited by John E. Schiel, Darryl L. Davis, and Oleg V. Borisov

ACS Symposium Series

The second of three volumes of this first-of-its kind, qualitative and quantitative biopharmaceutical reference book

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

The NISTmAb Case Study

Edited by John E. Schiel, Darryl L. Davis, and Oleg V. Borisov

Description

The focus of this volume is the characterization of monoclonal antibodies (mAbs). The book focuses both on general aspects, techniques, and regulatory concerns common to any recombinant protein, as well as specific analytical results. Volume 2 therefore serves as both a foundational body of NISTmAb product knowledge as well as an evaluation of its suitability as an industry-appropriate reference material (RM).

In Volume 1, a framework was presented, detailing what potential critical quality attributes (PCQAs) should be measured when developing mAbs; offering a risk-based approach to determining and quantifying PCQAs; specifying to what level PCQAs must be measured; and ultimately, explaining why it all matters. In Volume 2, the editors use that framework as a guide to deduce key biochemical and biophysical parameters of the NIST RM. The ultimate goal of Volume 2 is helping researchers have the clearest picture possible of the NIST RM specifically and mAb characterization in general.

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

The NISTmAb Case Study

Edited by John E. Schiel, Darryl L. Davis, and Oleg V. Borisov

ACS Symposium Series

1. Determination of the NISTmAb Primary Structure
2. Sequence Variants and Sequence Variant Analysis in Biotherapeutic Proteins
3. Structural Elucidation of Post-Translational Modifications in Monoclonal Antibodies
4. Orthogonal Technologies for NISTmAb N-Glycan Structure Elucidation and Quantitation
5. Separation Methods and Orthogonal Techniques
6. Biophysical Techniques for Characterizing the Higher Order Structure and Interactions of Monoclonal Antibodies
7. Developability Assessment of a Proposed NIST Monoclonal Antibody
8. Protein Particles (0.1 ?m to 100 ?m)
9. Analytical Methods for the Measurement of Host Cell Proteins and Other Process-Related Impurities

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

The NISTmAb Case Study

Edited by John E. Schiel, Darryl L. Davis, and Oleg V. Borisov

ACS Symposium Series

Author Information

Edited by John E. Schiel, Research Chemist, Biomolecular Measurement Division, National Institute of Standards and Technology, Darryl L. Davis, Associate Director, Janssen Research and Development, LLC, and Oleg V. Borisov, Director, Novavax, Inc.

Dr. John E. Schiel received his B.S. (2004) and Ph.D.(2009) in Chemistry from the University of Nebraska-Lincoln, and is currently a research chemist in the NIST Biomolecular Measurement Division.

Dr. Darryl L. Davis holds a doctorate in Medicinal Chemistry from the Philadelphia College of Pharmacy and Science. Currently he leads an analytical group within the discovery organization at Janssen R&D.

Dr. Oleg V. Borisov earned a B.S. degree (with honors) in Chemistry at Moscow State University (1992), and received his Ph.D. in Chemistry from Wayne State University (1997), after which he completed his post-doctoral studies at Lawrence Berkeley National Laboratories (2000) and Pacific Northwest National Laboratories (2001). He is currently a Director at Novavax, Inc., developing methods and strategies for analysis and characterization of recombinant vaccines, based on nano- and virus-like particle technologies.

Contributors:

Trina Formolo, Mellisa Ly, Michaella Levy, Lisa Kilpatrick, Scott Lute, Karen Phinney, Lisa Marzilli, Kurt Brorson, Michael Boyne, Melissa Alvarez, James A. Carroll, Paul W. Brown, Wenzhou Li, James L. Kerwin, Andrew Mahan, Sabrina A. Benchaar, Justin M. Prien, Henning Stöckmann, Simone Albrecht, Silvia M. Martin, Matthew Varatta, Marsha Furtado, Stephen Hosselet, Meiyao Wang, Pauline M. Rudd, David A. Michels, Anna Y. Ip, Thomas M. Dillon, Kurt Brorson, Scott Lute, Brittany Chavez, Ken M. Prentice, Lowell J. Brady, Karen J. Miller, Yatin Gokarn, Sanjeev Agarwal, Kelly Arthur, Alexander Bepperling, Eric S. Day, Dana Filoti, Daniel G. Greene, David Hayes, Rachel Kroe-Barrett, Thomas Laue, Jasper Lin, Brian McGarry, Vladimir Razinkov, Sanjaya Singh, Rosalynn Taing, Sathyadevi Venkataramani, William Weiss III, Danlin Yang, Isidro E. Zarraga, Dorina Saro, Audrey Baker, Robert Hepler, Stacey Spencer, Rick Bruce, Steven LaBrenz, Mark Chiu, Steven E. Lang, Dean C. Ripple, Linda O. Narhi, Kesh Prakash and Weibin Chen