"The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization, Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.-- Provided by publisher.

"This book covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions"-- Provided by publisher.

Includes bibliographical references and index.

Machine generated contents note: Dedication Chapter 1: Introduction to Biotherapeutics Jennie R. Lill Chapter 2: Mass Spectrometric Characterization of Recombinant Proteins Corey E Bakalarski, Wendy N Sandoval & Jennie R Lill Chapter 3: Characterizing the Termini of Recombinant Proteins Nestor Solis, Christopher M. Overall Chapter 4: Assessing activity & conformation of recombinant proteins Diego Ellerman, Till Maurer, Justin M. Scheer Chapter 5: Structural Characterization of Recombinant Proteins & Antibodies Paola Di Lello and Patrick Lupardus Chapter 6: Antibody de novo sequencing Natalie Castellana, Adrian Guthals Chapter 7: Characterization of Antibody Drug Conjugates Yichin Liu Chapter 8: Characterization of Bi-Specific or other Hybrid molecules T. Noelle Lombana and Christoph Spiess Chapter 9: Bio-Repository Anne Baldwin, Kurt Schroeder, Lovejit Singh, Karen Billeci Chapter 10: Characterization of Manufacturing Host-Cell Contaminant Proteins Denise Krawitz, Jason Rouse, Justin Sperry, Wendy Sandoval, Martin Vanderlaan Chapter 11: Analytical Tools for Biologics Molecular Assessment Wilson Phung, Wendy Sandoval, Robert F Kelley & Jennie R Lill Chapter 12: Glycan Characterization: Determining the Structure, Distribution, and Localization of Glycoprotein Glycans John Briggs INDEX.

Print version record and CIP data provided by publisher.

Chapter 1: Introduction to Biotherapeutics / Jennie R. Lill -- Chapter 2: Mass Spectrometric Characterization of Recombinant Proteins / Corey E Bakalarski, Wendy N Sandoval & Jennie R Lill -- Chapter 3: Characterizing the Termini of Recombinant Proteins / Nestor Solis, Christopher M. Overall -- Chapter 4: Assessing activity & conformation of recombinant proteins / Diego Ellerman, Till Maurer, Justin M. Scheer -- Chapter 5: Structural Characterization of Recombinant Proteins & Antibodies / Paola Di Lello and Patrick Lupardus -- Chapter 6: Antibody de novo sequencing / Natalie Castellana, Adrian Guthals -- Chapter 7: Characterization of Antibody Drug Conjugates / Yichin Liu -- Chapter 8: Characterization of Bi-Specific or other Hybrid molecules / T. Noelle Lombana and Christoph Spiess -- Chapter 9: Bio-Repository / Anne Baldwin, Kurt Schroeder, Lovejit Singh, Karen Billeci -- Chapter 10: Characterization of Manufacturing Host-Cell Contaminant Proteins / Denise Krawitz, Jason Rouse, Justin Sperry, Wendy Sandoval, Martin Vanderlaan -- Chapter 11: Analytical Tools for Biologics Molecular Assessment / Wilson Phung , Wendy Sandoval, Robert F Kelley & Jennie R Lill -- Chapter 12: Glycan Characterization: Determining the Structure, Distribution, and Localization of Glycoprotein Glycans / John Briggs -- INDEX.