Table Of ContentBiotechnology
DRUGS AND THE PHARMACEUTICAL SCIENCES
A Series of Textbooks and Monographs
Series Executive Editor
James Swarbrick
PharmaceuTech, Inc.
Pinehurst, North Carolina
Recent Titles in Series
Filtration and Purification in the Biopharmaceutical Industry, Third Edition
Maik W. Jornitz
Handbook of Drug Metabolism, Third Edition
Paul G. Pearson and Larry Wienkers
The Art and Science of Dermal Formulation Development
Marc Brown and Adrian C. Williams
Pharmaceutical Inhalation Aerosol Technology, Third Edition
Anthony J. Hickey and Sandro R. da Rocha
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
Graham P. Bunn
Pharmaceutical Extrusion Technology, Second Edition
Isaac Ghebre-Sellassie, Charles E. Martin, Feng Zhang, and James Dinunzio
Biosimilar Drug Product Development
Laszlo Endrenyi, Paul Declerck, and Shein-Chung Chow
High Throughput Screening in Drug Discovery
Amancio Carnero
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence,
Second Edition
Isadore Kanfer and Leon Shargel
Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Fourth Edition
Linda A. Felton
Good Design Practices for GMP Pharmaceutical Facilities, Second Edition
Terry Jacobs and Andrew A. Signore
Handbook of Bioequivalence Testing, Second Edition
Sarfaraz K. Niazi
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition
Edited by Leon Shargel and Isadore Kanfer
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition
Edited by Krzysztof Jozwiak, W. J. Lough, and Irving W. Wainer
Pharmaceutical Powder Compaction Technology, Second Edition
Edited by Metin Çelik
Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition
Edited by Steven W. Baertschi, Karen M. Alsante, and Robert A. Reed
Pharmaceutical Process Scale-Up, Third Edition
Edited by Michael Levin
Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality
Michael J. Akers
Biotechnology: The Science, the Products, the Government, the Business
Ronald P. Evens
For more information about this series, please visit: www.crcpress.com/Drugs-and-the-Pharmaceutical-Sciences/
book-series/IHCDRUPHASCI
DRUGS AND THE PHARMACEUTICAL SCIENCES
A Series of Textbooks and Monographs
Series Executive Editor
Biotechnology
James Swarbrick
PharmaceuTech, Inc.
Pinehurst, North Carolina
Recent Titles in Series The Science, the Products,
Filtration and Purification in the Biopharmaceutical Industry, Third Edition
Maik W. Jornitz the Government, the Business
Handbook of Drug Metabolism, Third Edition
Paul G. Pearson and Larry Wienkers
The Art and Science of Dermal Formulation Development
Marc Brown and Adrian C. Williams
Pharmaceutical Inhalation Aerosol Technology, Third Edition
Anthony J. Hickey and Sandro R. da Rocha
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
Graham P. Bunn
Pharmaceutical Extrusion Technology, Second Edition
Isaac Ghebre-Sellassie, Charles E. Martin, Feng Zhang, and James Dinunzio
Biosimilar Drug Product Development
Laszlo Endrenyi, Paul Declerck, and Shein-Chung Chow
High Throughput Screening in Drug Discovery
Amancio Carnero
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, Ronald P. Evens
Second Edition
Isadore Kanfer and Leon Shargel
Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Fourth Edition
Linda A. Felton
Good Design Practices for GMP Pharmaceutical Facilities, Second Edition
Terry Jacobs and Andrew A. Signore
Handbook of Bioequivalence Testing, Second Edition
Sarfaraz K. Niazi
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition
Edited by Leon Shargel and Isadore Kanfer
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition
Edited by Krzysztof Jozwiak, W. J. Lough, and Irving W. Wainer
Pharmaceutical Powder Compaction Technology, Second Edition
Edited by Metin Çelik
Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition
Edited by Steven W. Baertschi, Karen M. Alsante, and Robert A. Reed
Pharmaceutical Process Scale-Up, Third Edition
Edited by Michael Levin
Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality
Michael J. Akers
Biotechnology: The Science, the Products, the Government, the Business
Ronald P. Evens
For more information about this series, please visit: www.crcpress.com/Drugs-and-the-Pharmaceutical-Sciences/
book-series/IHCDRUPHASCI
First edition published 2020
by CRC Press
6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742
and by CRC Press
2 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN
© 2020 Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, LLC
ISBN: 9780367024673 (hbk)
ISBN: 9780429399299 (ebk)
Reasonable efforts have been made to publish reliable data and information, but the author and
publisher cannot assume responsibility for the validity of all materials or the consequences of their use.
The authors and publishers have attempted to trace the copyright holders of all material reproduced in
this publication and apologize to copyright holders if permission to publish in this form has not been
obtained. If any copyright material has not been acknowledged please write and let us know so we may
rectify in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced,
transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or
hereafter invented, including photocopying, microfilming, and recording, or in any information storage
or retrieval system, without written permission from the publishers.
For permission to photocopy or use material electronically from this work, access www.copyright.
com or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA
01923, 978-750-8400. For works that are not available on CCC please contact mpkbookspermissions@
tandf.co.uk
Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are
used only for identification and explanation without intent to infringe.
Library of Congress Cataloging‑in‑Publication Data
Names: Evens, Ronald P., author.
Title: Biotechnology : the science, the products, the government, the
business / by Ronald P. Evens.
Description: First edition. | Boca Raton, FL : CRC Press, 2020. | Series:
Drugs and the pharmaceutical sciences | Includes bibliographical
references and index.
Identifiers: LCCN 2020009451 | ISBN 9780367024673 (hardback) | ISBN
9780429399299 (ebook)
Subjects: LCSH: Pharmaceutical biotechnology. | Pharmaceutical
biotechnology industry.
Classification: LCC RS380 .E94 2020 | DDC 615.1/9--dc23
LC record available at https://lccn.loc.gov/2020009451
Typeset in Palatino
by Lumina Datamatics Limited
First edition published 2020
by CRC Press
6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742
Contents
and by CRC Press
2 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN
© 2020 Taylor & Francis Group, LLC
Preface .................................................................................................................ix
CRC Press is an imprint of Taylor & Francis Group, LLC Author .................................................................................................................xi
List of abbreviations ......................................................................................xiii
ISBN: 9780367024673 (hbk)
ISBN: 9780429399299 (ebk)
Reasonable efforts have been made to publish reliable data and information, but the author and Chapter 1 Introduction ..................................................................................1
publisher cannot assume responsibility for the validity of all materials or the consequences of their use.
History of biotechnology ..................................................................................1
The authors and publishers have attempted to trace the copyright holders of all material reproduced in
this publication and apologize to copyright holders if permission to publish in this form has not been Description of biotechnology ...........................................................................5
obtained. If any copyright material has not been acknowledged please write and let us know so we may Sciences of biotechnology .................................................................................8
rectify in any future reprint.
Current biotechnology product status ............................................................8
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced,
transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or
Chapter 2 Science of biotechnology – Recombinant
hereafter invented, including photocopying, microfilming, and recording, or in any information storage
or retrieval system, without written permission from the publishers. DNA technology .......................................................................13
For permission to photocopy or use material electronically from this work, access www.copyright.
Chapter 3 Science of biotechnology – Monoclonal antibody
com or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA
01923, 978-750-8400. For works that are not available on CCC please contact mpkbookspermissions@ technology ..................................................................................33
tandf.co.uk
Chapter 4 The science of biotechnology: Peptides,
Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are
used only for identification and explanation without intent to infringe. vaccines, cell and tissue therapy, liposomes,
nanobiotechnology, animal-sourced products ...................43
Library of Congress Cataloging‑in‑Publication Data
Peptides .............................................................................................................43
Names: Evens, Ronald P., author. Vaccines .............................................................................................................44
Title: Biotechnology : the science, the products, the government, the Tissue therapy ...................................................................................................46
business / by Ronald P. Evens.
Liposomes .........................................................................................................47
Description: First edition. | Boca Raton, FL : CRC Press, 2020. | Series:
Drugs and the pharmaceutical sciences | Includes bibliographical Nanobiotechnology .........................................................................................48
references and index. Animal and marine products .........................................................................50
Identifiers: LCCN 2020009451 | ISBN 9780367024673 (hardback) | ISBN
High-throughput screening ...........................................................................50
9780429399299 (ebook)
Subjects: LCSH: Pharmaceutical biotechnology. | Pharmaceutical Combinatorial chemistry ................................................................................50
biotechnology industry. Proteomics .........................................................................................................51
Classification: LCC RS380 .E94 2020 | DDC 615.1/9--dc23
Cell receptors, signal transduction and protein kinases ............................51
LC record available at https://lccn.loc.gov/2020009451
Cell therapy .......................................................................................................53
Cell therapy and immuno-oncology .............................................................56
Typeset in Palatino
by Lumina Datamatics Limited
v
vi Contents
Chapter 5 The science of biotechnology: Molecular engineering
(proteins, monoclonal antibodies, biosimilars) ..................57
Molecular engineering of proteins and peptides ........................................57
Glycosylation ....................................................................................................62
Pegylation ..........................................................................................................63
Monoclonal antibody engineering ................................................................64
Humanization of monoclonal antibodies and conjugates .........................64
Molecular fusion ..............................................................................................67
Biosimilars.........................................................................................................69
Biological product delivery and formulations .............................................70
Chapter 6 The science of biotechnology: Oligonucleotides and
genetics ........................................................................................73
Polymerase chain reaction ..............................................................................73
Oligonucleotide (RNA) therapeutics .............................................................73
Gene therapy .....................................................................................................76
Pharmacogenomics ..........................................................................................78
Biomarkers ........................................................................................................79
Transgenic animals ..........................................................................................80
Genomics ...........................................................................................................81
Gene editing ......................................................................................................82
Chapter 7 Laws and regulations governing biological
product approval and usage ...................................................85
Chapter 8 Biotechnology products and indications I. Proteins ..........95
Proteins – hormones ........................................................................................96
Proteins – enzymes ..........................................................................................98
Proteins – growth factors ..............................................................................100
Proteins – interferons and interleukins (cytokines) ..................................102
Proteins – blood coagulation factors ...........................................................103
Proteins – toxins .............................................................................................105
Fusion protein products ................................................................................105
Monoclonal antibodies ..................................................................................108
Chapter 9 Biotechnology products and indications II .......................117
Peptides ............................................................................................................117
Vaccine products ............................................................................................124
Liposomes .......................................................................................................124
Oligonucleotides.............................................................................................127
Tissue and cell engineering products .........................................................128
Polymers and other biotech products .........................................................131
Biological products (blood derivatives, tissue extracts, vaccines) ...........132
Contents vii
Chapter 10 Biotechnology industry .......................................................135
Biotech companies .........................................................................................135
Challenges of a biopharma company ..........................................................138
Culture of a biotech company ......................................................................139
Financing a biotech company .......................................................................140
A biopharma company structure ................................................................142
Product research and development in biopharma industry ...................147
BioPharma success factors – additional areas ............................................151
Overall measures of biotech success – product approvals,
company acceptance, and sales performance ............................................154
Biotechnology products and utilization .....................................................158
Summary .........................................................................................................159
Bibliography ..................................................................................................161
Index ................................................................................................................173
Preface
We have observed that “Biotechnology” over the last 50 years has truly
created and continues to result in a revolution – in scientific advances, in
the biopharma industry with leadership in novel product development,
and in health care advances with cures or substantial disease mitigation.
In my 45-plus years in pharmaceutical practice, academia and industry,
I have been fortunate to learn about and track biotechnology’s science
and business opportunities and advances and now can share my assimi-
lated biotechnology information with my colleagues in academia and
industry in this form of a book, Biotechnology: The Science, the Products,
the Government, the Business. I have been very fortunate in my profession
and career to have had manifold, broad, and challenging work environ-
ments and substantial growth opportunities. The intent of this book is
for me to give back and to offer material (narratives and my data slides)
to further enhance the educational opportunities in biotechnology and to
assist in the mentoring and education of pharmacy, medical, and graduate
students and young practitioners. I thank my family and mentors at the
universities at Buffalo, Kentucky, and Texas for their advice and support,
early in my education and career.
ix
