State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1.

Monoclonal Antibody Therapeutics: Structure, Function, and Regulatory Space

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

ACS Symposium Series

A first-of-its kind, qualitative and quantitative biopharmaceutical reference book

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1.

Monoclonal Antibody Therapeutics: Structure, Function, and Regulatory Space

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

Description

Monoclonal antibodies (mAbs) are an important class of therapeutic that has greatly expanded our ability to treat a variety of indications, including cancer, autoimmune disorders, and infectious diseases. The cost of developing these molecules and ensuring that they are fit for purpose is much higher than for small-molecule drugs. Although some of these costs are due in part to the nature of production, a major cost is incurred because of the complexity of the molecule itself. Extensive analytical testing regimes are needed for in-depth characterization and to ensure product stability, proper in-process controls, safety, and efficacy. The next generation of product understanding will require highly complex, orthogonal technologies to elucidate interdependent structure-function relationships.

The ACS' focus on this field of research represents a defining moment in the development of technologies for characterizing mAbs. A multitude of experts in the field have come together around a single molecule for the first time to demonstrate both current and future practices involved in the characterization of a biotherapeutic. The current series presents an open discussion of current best practices, a multitude of intuitive research, and a collaborative philosophy on where the field needs to move to satisfy future scientific and regulatory needs. Throughout this effort, a first-of-a-kind repository of regulatory considerations, experimental methods, and data—as well as a widely available "reference"—are now available to industry, academia, regulatory personnel, and instrument manufacturers.

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1.

Monoclonal Antibody Therapeutics: Structure, Function, and Regulatory Space

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

ACS Symposium Series

1. Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials
2. Monoclonal Antibodies: Mechanisms of Action
3. Heterogeneity of IgGs: Role of Production, Processing, and Storage on Structure and Function
4. Perspectives on Well-Characterized Biological Proteins
5. Using Quality by Design Principles in Setting a Control Strategy for Product Quality Attributes
Appendix
Editors' Biographies
Indexes
Author Index
Subject Index

State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1.

Monoclonal Antibody Therapeutics: Structure, Function, and Regulatory Space

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

ACS Symposium Series

Author Information

Edited by John E. Schiel, Research Chemist, National Institute of Standards and Technology, Edited by Darryl L. Davis Davis, Associate Director, Janssen Research and Development, LLC, and Edited by 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:

John E. Schiel, Anthony Mire-Sluis, Roy Jefferis, Chris Barton, David Spencer, Sophia Levitskaya, Jinhua Feng, Reed Harris, Mark A. Schenerman, Kurt Brorson, Brent Kendrick, Gregory C. Flynn and Gregg B. Nyberg