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Characterizing Biotherapeutics (eBook)

Analytical Methods for Diverse Modalities
eBook Download: EPUB
2025
1326 Seiten
Wiley (Verlag)
978-1-394-23612-1 (ISBN)

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Provides detailed and up-to-date coverage of analytical approaches for biologic drug modalities

The development of innovative biologic therapies has revolutionized medicine, but their complexity demands equally advanced analytical approaches. Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities introduces the tools and techniques used to analyze these groundbreaking therapies. Designed to help readers characterize and troubleshoot increasingly diverse and sophisticated therapeutic molecules, this in-depth guide addresses different biologic drugs, their unique analytical challenges, and the methods that enable their analysis.

Organized into two comprehensive sections, Characterizing Biotherapeutics first delves into the fundamentals of analytical platforms, providing a robust foundation in techniques such as mass spectrometry and biophysical assays. The second section applies these methods to real-world scenarios, focusing on drug discovery, clinical evaluation, and commercial considerations in drug development. Authors Jennie R. Lill and Wendy Sandoval provide clear guidance tailored to the evolving demands of therapeutic innovations such as structural characterization, high-throughput biophysical assays, and RNA-based therapeutics.

Equipping researchers with the knowledge to navigate the challenges posed by increasingly complex biologics, Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities:

  • Discusses new and emerging biological molecule diversity and both traditional analytical methods
  • Provides characterization strategies for large molecule (protein/antibody) based therapeutics
  • Summarizes cutting-edge technologies for novel modalities and antibody protein therapeutics
  • Incorporates the latest advancements in mass spectrometry, functional assays, and biophysical methods
  • Addresses specialized analytical issues for membrane proteins and other challenging targets
  • Presents methodologies for assessing safety and therapeutic potential

Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities is an essential reference for analytical scientists, biologists, and mass spectrometrists involved in biomolecule analysis. It is also a valuable resource for graduate students taking advanced courses in biotechnology, drug development, and biotherapeutic analysis, as well as professionals in biotechnology and pharmaceutical industries working to advance biotherapeutic research and development.

Jennie R. Lill, PhD, is the Executive Director of the Proteomic and Genomic Technologies Department at Genentech, where she has worked since 2004. With over 90 peer-reviewed publications and three books, including Analytical Characterization of Biotherapeutics, her work focuses on cutting-edge analytical techniques in drug discovery and development.

Wendy Sandoval was the Director of Translational Mass Spectrometry in Research at Genentech, where she had been a pivotal contributor for over 30 years. She has authored more than 100 scientific publications and co-authored two books, including Analytical Characterization of Biotherapeutics. She now runs a plant nursery and botanical garden in Northern California (https://botanicanurseryandgardens.com/) and enjoys playing in dirt.


Provides detailed and up-to-date coverage of analytical approaches for biologic drug modalities The development of innovative biologic therapies has revolutionized medicine, but their complexity demands equally advanced analytical approaches. Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities introduces the tools and techniques used to analyze these groundbreaking therapies. Designed to help readers characterize and troubleshoot increasingly diverse and sophisticated therapeutic molecules, this in-depth guide addresses different biologic drugs, their unique analytical challenges, and the methods that enable their analysis. Organized into two comprehensive sections, Characterizing Biotherapeutics first delves into the fundamentals of analytical platforms, providing a robust foundation in techniques such as mass spectrometry and biophysical assays. The second section applies these methods to real-world scenarios, focusing on drug discovery, clinical evaluation, and commercial considerations in drug development. Authors Jennie R. Lill and Wendy Sandoval provide clear guidance tailored to the evolving demands of therapeutic innovations such as structural characterization, high-throughput biophysical assays, and RNA-based therapeutics. Equipping researchers with the knowledge to navigate the challenges posed by increasingly complex biologics, Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities: Discusses new and emerging biological molecule diversity and both traditional analytical methods Provides characterization strategies for large molecule (protein/antibody) based therapeutics Summarizes cutting-edge technologies for novel modalities and antibody protein therapeutics Incorporates the latest advancements in mass spectrometry, functional assays, and biophysical methods Addresses specialized analytical issues for membrane proteins and other challenging targets Presents methodologies for assessing safety and therapeutic potential Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities is an essential reference for analytical scientists, biologists, and mass spectrometrists involved in biomolecule analysis. It is also a valuable resource for graduate students taking advanced courses in biotechnology, drug development, and biotherapeutic analysis, as well as professionals in biotechnology and pharmaceutical industries working to advance biotherapeutic research and development.

List of Contributors


 

Corey E. Bakalarski

Proteomic and Genomic Technologies

Genentech Inc.

South San Francisco, CA

USA

 

Mercedesz Balasz

Biochemical and Cellular Pharmacology

Genentech

South San Francisco

CA, USA

 

Marcus Bantscheff

Target Discovery, GSK

Heidelberg

Germany

 

and

 

Research and Early Development

Roche Pharma

Basel

Switzerland

 

Hayley M. Bennett

Department of Proteomic and Genomic Technologies

Genentech Research and Early Development

South San Francisco, CA

USA

 

Maureen Beresini

Department of Biochemical and Cellular Pharmacology

Genentech Inc.

South San Francisco, CA

USA

 

Tess Branon

Proteomic & Genomic Technologies Department

Genentech Inc.

South San Francisco, CA

USA

 

Ashley Byrne

Department of Proteomic and Genomic Technologies

Genentech Research and Early Development

South San Francisco, CA

USA

 

Julien Camperi

Cell Therapy Engineering and Development

Genentech

South San Francisco, CA

USA

 

Shengya Cao

Development

Inceptive

Palo Alto, CA

USA

 

Naincy R. Chandan

Discovery Technology

Nurix Therapeutics, Inc.

San Francisco, CA

USA

 

Jieming Chen

gRED Computational Sciences

Genentech

South San Francisco, CA

USA

 

Sivan Cohen

Bioanalytical Sciences

Genentech, Inc.

South San Francisco, CA

USA

 

Phillip Chu

Genentech, Inc.

South San Francisco, CA

USA

 

Michael Dillon

Department of Antibody Engineering

Genentech Research and Early Development

South San Francisco, CA

USA

 

H. Christian Eberl

Target Discovery, GSK

Heidelberg

Germany

 

Alberto Estevez

Thomson Instrument Company

Carlsbad, CA

USA

 

Amin Famili

Department of Synthetic Molecule Analytical Chemistry

Genentech

South San Francisco, CA

USA

 

Abel Ferrel

Independent Researcher

San Francisco, CA

USA

 

Emily Freund

Department of Molecular Biology

Genentech

South San Francisco, CA

USA

 

Manasi Gaikwad

Center for Mass Spectrometry and Optical Spectroscopy (CeMOS)

Mannheim University of Applied Sciences

Mannheim

Germany

 

Carolina Galan

Department of Molecular Biology

Genentech

South San Francisco, CA

USA

 

Amy Gilbert

Adaptive Biotechnologies

Seattle, WA

USA

 

Alissa D. Guarnaccia

Department of Proteomic and Genomic Technologies

Genentech

South San Francisco, CA

USA

 

and

 

Proteomic and Genomic Technologies

Genentech Inc.

South San Francisco, CA

USA

 

Axel Guilbaud

Protein Analytical Chemistry

Genentech

South San Francisco, CA

USA

 

Albert J.R. Heck

Biomolecular Mass Spectrometry and Proteomics

Bijvoet Center for Biomolecular Research and Utrecht Institute for Pharmaceutical Sciences

University of Utrecht

Utrecht

The Netherlands

 

and

 

Netherlands Proteomics Center

Utrecht

The Netherlands

 

Suk‐Joon Hyung

Genentech, Inc.

South San Francisco, CA

USA

 

Saeed Izadi

Pharmaceutical Development

Genentech Inc.

South San Francisco, CA

USA

 

Eric Janezic

Biochemical and Cellular Pharmacology

Genentech Inc.

South San Francisco, CA

USA

 

Christine C. Jao

Department of Structural Biology

Genentech Inc.

South San Francisco, CA

USA

 

Hiruni S. Jayasekera

Department of Chemistry and Biochemistry

The University of Arizona

Tucson, AZ

USA

 

Robert S. Jones

Drug Metabolism and Pharmokinetics

Genentech, Inc.

South San Francisco, CA

USA

 

S. Cyrus Khojasteh

Genentech, Inc.

South San Francisco, CA

USA

 

Sascha Knecht

Target Discovery, GSK

Heidelberg

Germany

 

Felix Kuhne

Analytical Characterization, Pharma Technical Development

Roche Diagnostics GmbH

Penzberg

Germany

 

M. Violet Lee

Bioanalytical Sciences

Genentech

South San Francisco, CA

USA

 

Paola Di Lello

Department of Structural Biology

Genentech, Inc.

South San Francisco, CA

USA

 

Dennis H. Leung

Genentech, Inc.

South San Francisco, CA

USA

 

Amritha Lewis

Adaptive Biotechnologies

Seattle, WA

USA

 

Yinyin Li

Biochemical and Cellular Pharmacology

Genentech

South San Francisco, CA

USA

 

Jennie R. Lill

Department of Proteomic and Genomic Technologies

Genentech

South San Francisco, CA

USA

 

and

 

Proteomic and Genomic Technologies

Genentech Inc.

South San Francisco, CA

USA

 

and

 

Proteomic and Genomic Technologies

Genentech

South San Francisco, CA

USA

 

Rachel P. Liu

Protein Analytical Chemistry

Genentech Inc.

South San Francisco, CA

USA

 

T. Noelle Lombana

Department of Antibody Engineering

Genentech Research and Early Development

South San Francisco, CA

USA

 

and

 

ReCode Therapeutics

Menlo Park, CA

USA

 

Kelly Loyet

Department of Biochemical and Cellular Pharmacology

Genentech Inc.

South San Francisco, CA

USA

 

Patrick Lupardus

Department of Structural Biology

Genentech, Inc.

South San Francisco, CA

USA

 

Bin Ma

Genentech, Inc.

South San Francisco, CA

USA

 

Michael T. Marty

Department of Chemistry and Biochemistry

The University of Arizona

Tucson, AZ

USA

 

Rebecca Melmon

Adaptive Biotechnologies

Seattle, WA

USA

 

Madyson Migliozzi

Department of Pharmaceutical Development

Genentech

South San Francisco, CA

USA

 

Zora Modrusan

Department of Proteomic and Genomic Technologies

Genentech Research and Early Development

South San Francisco, CA

USA

 

Farhana Afrin Mohona

Department of Chemistry and Biochemistry

The University of Arizona

Tucson, AZ

USA

 

Huy Nguyen

Genentech, Inc.

South San Francisco, CA

USA

 

Emma Pelegri‐O'Day

Amgen Research, Amgen Inc.

South San Francisco, CA

USA

 

Qui T. Phung

Proteomic and Genomic Technologies

Genentech

South San Francisco, CA

USA

 

Emile Plise

Genentech, Inc.

South San Francisco, CA

USA

 

Markus A. Queisser

Modality Platform Technologies, GSK

Medicines Research Centre

Stevenage

UK

 

Roshan M. Regy

Pharmaceutical Development

Genentech Inc.

South San Francisco, CA

USA

 

Amber D. Rolland

Biomolecular Mass Spectrometry and Proteomics

Bijvoet Center for Biomolecular Research and Utrecht Institute for Pharmaceutical Sciences

University of Utrecht

Utrecht

The Netherlands

 

and

 

Netherlands Proteomics Center

Utrecht

The Netherlands

 

Ola M. Saad

Genentech, Inc.

South San Francisco, CA

USA

 

and

 

Bioanalytical Sciences

Genentech

South San Francisco, CA

USA

 

Sudeshna Sadhu

Adaptive...

Erscheint lt. Verlag 6.6.2025
Sprache englisch
Themenwelt Naturwissenschaften Chemie Organische Chemie
Schlagworte biologic characterization techniques • biotherapeutics • biotherapeutics analytical methods • biotherapeutics characterization • biotherapeutics characterization, mass spectrometry biotherapeutics • cell therapies analysis • drug discovery analytical methods • mass spectrometry biotherapeutics • RNA therapeutics analysis
ISBN-10 1-394-23612-3 / 1394236123
ISBN-13 978-1-394-23612-1 / 9781394236121
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