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Preface

antibody-drug conjugates (ADCs), biopharmaceutical analytics, regulatory CMC and the tech transfer and emerging trends in biologics of biopharmaceuticals.

We are hoping to reach global readers across academia as well as the pharmaceutical and biopharmaceutical industries and look forward to their participation and input for future work.

San Francisco, CA, USA KumarGadamasetti Chestereld, MO, USA StephenA.Kolodziej

Acknowledgements

We would like to thank the many contributors of this volume for their hard work, dedication, manuscripts, and their patience. In addition, we want to thank the reviewers of these manuscripts, as they were entrusted with assuring the quality of the content and strengthening the high level of the science presented. We believe the signicant contributions of Rosalind Franklin laid the pathway to our modern understanding of the structure of DNA, and this led to the signicant advances made in the twenty-rst century in bioengineering and bioprocessing detailed in this book.

We would like to extend special thanks to Anita Lekhwani, Bo Arve, Aaron Sato and Dianne Shumay for working with us during the initial phases of the book and helping with valuable suggestions.

We thank the staff at Springer-Nature Publishers for their outstanding support throughout the journey and for cooperating with late-breaking changes.

xiii

Part I Overview

1 Bioprocessing, Bioengineering and Process Chemistry

in the Biopharmaceutical Industry: Using Chemistry

and Bioengineering to Improve the Performance of Biologics . . . . . . 3

Kumar Gadamasetti

Part II Synthetic Biology

2 Synthetic Biology in Drug Development and Beyond . . . . . . . . . . . . . 25

Aaron K. Sato and Stephen Rife

Part III Oligonucleotide Synthetic Chemistry to DNA Synthesis,

Bioprocessing and Manufacturing

3 Increasing the Scalability of DNA Synthesis and Its Key Role

in Expanding the Biopharmaceutical Discovery Process . . . . . . . . . . 55

Rebecca L. Nugent and Aaron K. Sato

4 Advancements in the Manufacture of Monoclonal Antibodies

and Other Large Molecule Protein Therapeutics: Recent Innovations in Cell Culture Technology Enabling Process

Intensification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Gregory W. Hiller

5 Process Development and Manufacturing Considerations

for Multispecific (Bispecific and Trispecific) Antibodies:

Case Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Timothy Iskra, Ashley Sacramo, and John J. Scarcelli

xvi

Contents

Part IV Process Engineering, Gene Therapy and Vaccines

6 Metabolic and Process Engineering to Control Glycan Structures

for Biopharmaceuticals Produced in Cultured Mammalian Cells . . . 135

Ranya Pranomphon, Vijay Tejwani, Hussain Dahodwala, Montarop Yamabhai, and Susan T. Sharfstein

7 Even a Worm Will Turn: Immunity Following AAV Vector

Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Kruti Patel, Arpana Khatri, and Suryanarayan Somanathan

8 COVID-19 Vaccine Manufacturing Processes: Making

the Molecules to Solve the Pandemic. . . . . . . . . . . . . . . . . . . . . . . . . . . 185

Jennifer A. S. Romine, Stephen A. Kolodziej, Tarl Vetter, and Michael P. Dux

Part V Special Topics: CAR-T and CRISPR Technologies

and Applications

9 CAR-T Bioprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Adebola Adeniran, Salina Handy, and Abdulrahman Baki

10 CRISPR Technology and Its Application in Therapeutics . . . . . . . . . 259

Rigel Kishton, Montse Morell, Kevin Holden, Meenakshi Prabhune, Rebecca Roberts, Bobby Moon, and Rebecca L. Nugent

Part VI Fusion Proteins, Antibody Drug Conjugates

and Process Chemistry

11 Fusion Proteins: Current Status and Future Perspectives . . . . . . . . . 287

Stefan R. Schmidt

12 Development of Antibody-Drug Conjugates. . . . . . . . . . . . . . . . . . . . . 345

David Y. Jackson

13 Mylotarg: The Journey to FDA Reapproval and Broad

International Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 381

Leo Letendre, Durgesh Nadkarni, and Frank Kotch

Part VII Biopharmaceutical Informatics and Analytics

14 Biopharmaceutical Informatics: A Strategic Vision

for Discovering Developable Biotherapeutic Drug Candidates . . . . . 405

Joschka Bauer, Sebastian Kube, Pankaj Gupta, and Sandeep Kumar

15 Advanced Data Analytics Application in Biomanufacturing

Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437

Jun Luo, Lin Qiu, Yang Tang, Grant Sumida, Sid Kundu, and Yiming Peng

Contents

xvii

Part VIII Biopharmaceutical Regulatory CMC

16 Overview of Complexities of Global CMC Regulatory Affairs . . . . . 457

Katherine Arch-Douglas, Nathalie Dubois, Stephen Mayer, Rich Pelt, and Andrew Nelson

17 CMC Considerations for Continuous Bioprocess Design,

Development, and Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 473

Yanhuai (Richard) Ding and Margaret (Peggy) Marino

Part IX Technology Transfer

18 Three Decades of Advancements in Technical Transfer

of Biologics: A Blueprint for Advanced Therapeutics . . . . . . . . . . . . . 503

Mairead Looby, Ciaran Brady, Melissa Bentley, Amanda M. Lewis, Conor Layden, Barak Barnoon, Erin Abbott, and Brendan Hughes

Part X Emerging Trends and Future of Biopharmaceuticals

19 Emerging Biopharmaceutical Technologies and Trends . . . . . . . . . . . 533

David W. Woods and Izabela Gierach

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553

Contributors

Erin Abbott Global Product Development and Supply, Bristol-Myers Squibb

Company, East Syracuse, NY, USA

Adebola Adeniran Cell Therapy Process Development, The Center for

Breakthrough Medicine, King of Prussia, PA, USA

Katherine Arch-Douglas Global Regulatory Sciences CMC, Pzer Inc., Pearl

River, NY, USA

AbdulrahmanBaki Cell and Gene Therapy, Medicinal Science and Technology,

GlaxoSmithKline, Stevenage, UK

BarakBarnoon Global Product Development and Supply, Bristol-Myers Squibb

Company, Devens, MA, USA

JoschkaBauer Pharmaceutical Development Biologicals, Boehringer Ingelheim

Pharma GmbH & Co. KG, Biberach/Riss, Germany

MelissaBentley Global Product Development and Supply, Bristol Myers Squibb,

Phoenix, AZ, USA

Ciaran Brady Global Product Development and Supply, Bristol Myers Squibb,

Devens, MA, USA

JenniferR.Cochran Schools of Medicine and Engineering, Stanford University,

Shriram Center, Stanford, CA, USA

Hussain Dahodwala Institute for Bioscience and Biotechnology Research,

University of Maryland, Rockville, USA

Yanhuai (Richard) Ding CMC Drug Substance/Drug Product, EvolveImmune

Therapeutics, Branford, CT, USA

NathalieDubois Global Regulatory Sciences CMC, Pzer Inc., Brussels, Belgium

MichaelP.Dux Pzer Global Supply, Pzer Inc., Sanford, NC, USA

xix

Contributors

KumarGadamasetti Certum Bio, San Francisco, CA, USA

IzabelaGierach Protein Capture Science, Columbus, OH, USA

PankajGupta In Silico Team, Biotherapeutics Discovery, Boehringer– Ingelheim

Pharmaceutical Inc., Ridgeeld, CT, USA

SalinaHandy Manufacturing Science and Technology, Lonza, Houston, TX, USA

Gregory W. Hiller Bioprocess Research and Development, Biotherapeutics

Pharmaceutical Sciences, Pzer Inc., Andover, MA, USA

KevinHolden Synthego Corporation, Redwood City, CA, USA

BrendanHughes Global Product Development and Supply, Bristol Myers Squibb,

Devens, MA, USA

Timothy Iskra Bioprocess Research and Development, Biotherapeutics

Pharmaceutical Sciences, Pzer Inc., Andover, MA, USA

DavidY.Jackson DYJ Pharma, San Mateo, CA, USA

ArpanaKhatri Rare Disease Research Unit, Pzer, Inc., Cambridge, MA, USA

RigelKishton Moonwalk Biosciences, South San Francisco, CA, USA

Stephen A. Kolodziej Bioprocess Research and Development, Biotherapeutics

Pharmaceutical Sciences, Pzer Inc., Chestereld, MO, USA

Frank Kotch Bioprocess Research and Development, Biotherapeutics

Pharmaceutical Sciences, Pzer Inc., Chestereld, MO, USA

SebastianKube Pharmaceutical Development Biologicals, Boehringer Ingelheim

Pharma GmbH & Co. KG, Biberach/Riss, Germany

SandeepKumar Computational Protein Design and Modeling Biopharmaceutical

Informatics, Moderna, Cambridge, MA, USA

Sid Kundu Cell Culture and Bioprocess Operations, Genentech, South San

Francisco, CA, USA

ConorLayden Global Product Development and Supply, Bristol Myers Squibb,

Dublin, Ireland

LeoLetendre Leo Letendre Consulting, LLC, Oakdale, CT, USA

Amanda M. Lewis Global Product Development and Supply, Bristol Myers

Squibb, Devens, MA, USA

MaireadLooby Global Product Development and Supply, Bristol Myers Squibb,

Dublin, Ireland

JunLuo Manufacturing Sciences, Genentech, Vacaville, CA, USA

Contributors

xxi

Margaret(Peggy)Marino Downstream Process Development & Manufacturing,

AnaptysBio, San Diego, CA, USA

StephenMayer Global Regulatory Sciences CMC, Pzer Inc., Pearl River, NY, USA

BobbyMoon Synthego Corporation, Redwood City, CA, USA

MontseMorell EditCo Bio, Redwood City, CA, USA

TaritK.Mukhopadhyay Merck Research Labs, West Point, PA, USA

Durgesh Nadkarni Bioprocess Research and Development, Biotherapeutics

Pharmaceutical Sciences, Pzer Inc., Chestereld, MO, USA

AndrewNelson Global Regulatory Sciences CMC, Pzer Inc., Sanford, NC, USA

RebeccaL.Nugent Tessera Therapeutics, Sommerville, MA, USA

KrutiPatel Rare Disease Research Unit, Pzer, Inc., Cambridge, MA, USA

RichardPelt Global Regulatory Sciences CMC, Pzer Inc., Sanford, NC, USA

Yanhuai (Richard) Ding Nonclinical Biostatistics, Genentech, South San

Francisco, CA, USA

MeenakshiPrabhune The Scientist, Lab X Media Group, Midland, ON, Canada

Ranya Pranomphon School of Biotechnology, Institute of Agricultural

Technology, Suranaree University of Technology, Nakhon Rachasima, Thailand

LinQiu Nonclinical Biostatistics, Genentech, South San Francisco, CA, USA

StephenRife Twist Bioscience, South San Francisco, CA, USA

RebeccaRoberts Synthego Corporation, Redwood City, CA, USA

JenniferA.S.Romine Bioprocess Research and Development, Biotherapeutics

Pharmaceutical Sciences, Pzer Inc., Chestereld, MO, USA

AshleySacramo Solid Biosciences Inc., Charlestown, MA, USA

AaronK.Sato Twist Bioscience, South San Francisco, CA, USA

JohnJ.Scarcelli Sano, Framingham, MA, USA

StefanR.Schmidt evitria AG, Zurich, Switzerland

Susan T. Sharfstein College of Nanoscale Science and Engineering, SUNY

Polytechnic Institute, Albany, NY, USA

Suryanarayan Somanathan Rare Disease Research Unit, Pzer, Inc.,

Cambridge, MA, USA

GrantSumida Manufacturing Sciences, Genentech, Vacaville, CA, USA

YangTang Nonclinical Biostatistics, Roche, Mississauga, ON, Canada

xxii

Contributors

VijayTejwani College of Nanoscale Science and Engineering, SUNY Polytechnic

Institute, Albany, NY, USA

TarlVetter Novartis Pharmaceuticals Corporation, Durham, NC, USA

Nicholas W. Warne Biotherapeutics Pharmaceutical Sciences, Pzer Inc.,

Andover, MA, USA

DavidW.Woods Department of Chemical and Biomolecular Engineering, Ohio

State University, Columbus, OH, USA

MontaropYamabhai College of Nanotechnology, Science and Engineering, State

University of NewYork, Albany, NY, USA

About the Editors

Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical

executive with a strong operations mindset combined with integrating pragmatic strategic vision. Currently, he is the CEO of Certum Bio in San Francisco Bay area and has a joint appointment as the Member of the Board of Advisors with the University of California Berkeley Postdoctoral Entrepreneurial Program (BPEP). Over the past 30years, his focus has been in developing small molecules and biologics and marketing programs, efcient operations, R&D involving drug substance (API) and drug product (formulations) and outsourcing management of both sides of business with CDMOs and CROs. Kumar actively consults with both pharma/ biopharma and the academic institutions and enjoys being a liaison connecting academia to the industry and vice versa. The therapeutic areas include cancer, CV, CNS and infectious diseases. He worked in Fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market (PaclitaxelTM—Bristol-Myers Squibb; SensiparTM— Amgen and DuexisTM—Horizon Therapeutics). As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on “Process Chemistry in the Pharmaceutical Industry,” and as the chair, speaker and moderator at numerous national and international conferences on API Process Chemistry and Drug Discovery and Development. He has been a Visiting Professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and Visiting Speaker at Humboldt U. in Berlin, Germany. In addition to several peer-reviewed publications and patents, he published two volumes on Process Chemistry in the Pharmaceutical

Industry [1997 & 2008] and the current volume entitled, Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry-Using Chemistry and Bioengineering to Improve the Performance of Biologics [2024].

Kumar’s current interests include cancer and immunotherapy—ADCs as cancer therapeutics, API process R&D, drug formulations and manufacturing, new

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