Biopharmaceutical Production Technology

Ganapathy Subramanian

• Publisher: Wiley-VCH
• Year: 2012
• Print ISBN: 9783527330294
• eBook ISBN: 9783527653119
• Edition: 1
• Topic: Medicine
• Subtopic: Pharmacology

Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes.

This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals.

It is divided into seven major parts:
- Upstream Technologies
- Protein Recovery
- Advances in Process Development
- Analytical Technologies
- Quality Control
- Process Design and Management
- Changing Face of Processing

With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

The Editor

Dr. Ganapathy Subramanian

44 Oaken Grove

Maidenhead

Berkshire SL6 6HH

United Kingdom

All books published by Wiley-VCH are carefully produced. Nevertheless, authors, editors, and publisher do not warrant the information contained in these books, including this book, to be free of errors. Readers are advised to keep in mind that statements, data, illustrations, procedural details or other items may inadvertently be inaccurate.

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© 2012 Wiley-VCH Verlag & Co. KGaA, Boschstr. 12, 69469 Weinheim, Germany

All rights reserved (including those of translation into other languages). No part of this book may be reproduced in any form – by photoprinting, microfilm, or any other means – nor transmitted or translated into a machine language without written permission from the publishers. Registered names, trademarks, etc. used in this book, even when not specifically marked as such, are not to be considered unprotected by law.

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Print ISBN: 978-3-527-33029-4

ePDF ISBN: 978-3-527-65312-6

ePub ISBN: 978-3-527-65311-9

mobi ISBN: 978-3-527-65310-2

oBook ISBN: 978-3-527-65309-6

Preface

Over a few decades the advancement of technologies and our understanding and demands has rejuvenated the biotechnology industries in finding biologicals with therapeutic value. Thus, currently over 12 000 large-molecule biotherapeutic products are in preclinical discovery or clinical trials around the world today; however, less than one-third of these are in clinical development and very few have found a successful market. As the demand for healthcare products increases around the globe, the need to produce cost-effective therapeutic solutions for the world community has to be met by the biotechnology industries. It is a challenge that the industries have to embrace to face the future and it is clear that the industries have to adapt in order to survive.

The issues at stake are as complex as they are well known. With the current global situation, serious questions of facility financing, and a shift in health­care policy and reimbursement all create a massive burden on strategic plan­ning. The industries realize the need to adapt to face the future in effective manufacturing.

Volume 1 of this book is organized into three parts containing 12 chapters contributed by experienced international scientists. The first two chapters give an overview of strategies for plasmid DNA production from Escherichia coli and advances in protein production technology. Chapters 3–7 give a perspective of the methodologies for protein recovery. An overview of process development is given in Chapters 8–12.

My thanks to all of the authors who have devoted their spare time, and also for their diligence, patience, and goodwill during the production of the volume. They deserve the full credit for the source of the volume.

It is hoped that this volume will be of great value to all those who are involved in the processing and production of bioproducts, and that it will stimulate further progress and advances in this field to meet the ever-increasing demands and challenges.

I should be most grateful for any suggestion that could serve to improve future editions of this volume.

Finally, my deep appreciation to Dr. Frank Weinreich of Wiley-VCH for inviting me to edit the volume, and also to Lesley Belfit and her colleagues for their sustained support and help.

G. Subramanian
June 2012
Maidenhead, UK

List of Contributors

Lars Aumann
ChromaCon AG
Technoparkstrasse 1
8005 Zürich
Switzerland

Andy Bailey
Virusure GmbH
Wissenschafts- und Technologiepark
Donau-City-Strasse 1
1220 Wien
Austria

Miloš Barut
BIA Separations d.o.o.
Teslova 30
1000 Ljubljana
Slovenia
and
The Center of Excellence for Biosensors
Instrumentation and Process Control – COBIK
Velika pot 22
5250 Solkan
Slovenia

Marc Bisschops
Tarpon Biosystems Inc.
Batavia Bioservices B.V.
Zernikedreef 9
2333 CK Leiden
The Netherlands

Eva Brand
Technische Universität Berlin
Department of Biotechnology
Ackerstrasse 71–76
13355 Berlin
Germany

Yap Pang Chuan
University of Queensland
Australian Institute for Bioengineering and Nanotechnology
Corner College and Cooper Roads
Brisbane, Queensland 4072
Australia

Vinod B. Damodaran
Colorado State University
Department of Chemistry
Fort Collins, CO 80523
USA

Reinhard Ditz
Merck KGaA
Performance & Life Science Chemicals R&D
Frankfuter Strasse 250
64293 Darmstadt
Germany

Graziella El Khoury
University of Cambridge
Institute of Biotechnology
Department of Chemical Engineering and Biotechnology
Tennis Court Road
Cambridge CB2 1QT
UK

Robert Falconar
University of Sheffield
ChELSI Institute
Department of Chemical and Biological Engineering
Mappin Street
Sheffield S1 3JD
UK

Suzanne S. Farid
University College London
Advanced Centre for Biochemical Engineering
Department of Biochemical Engineering
Torrington Place
London WC1E 7JE
UK

Conan J. Fee
University of Canterbury
Biomolecular Interaction Centre
Department of Chemical and Process Engineering
Private Bag 4800
Christchurch 8020
New Zealand

Daryl L. Fernandes
Ludger Ltd
Culham Science Centre
Abingdon OX14 3EB
UK

Richard Francis
Francis Pharma
38 Longmeadow
Riverhead, Kent TN13 2QY
UK

Ruth Freitag
University of Bayreuth
Process Biotechnology
Universitätsstrasse 30
95440 Bayreuth
Germany

Florian Grote
Clausthal University of Technology
Institute for Separation and Process Technology
Leibnizstrasse 15
38678 Clausthal-Zellerfeld
Germany

Christoph Helling
Clausthal University of Technology
Institute for Separation and Process Technology
Leibnizstrasse 15
38678 Clausthal-Zellerfeld
Germany

Frank Hilbrig
University of Bayreuth
Process Biotechnology
Universitätsstrasse 30
95440 Bayreuth
Germany

Dirk Itzeck
Technische Universität Berlin
Department of Biotechnology
Ackerstrasse 71–76
13355 Berlin
Germany

Maik W. Jornitz
Sartorius Stedim North America Inc.
5 Orville Drive
Bohemia, NY 11716
USA

Stefan Junne
Technische Universität Berlin
Department of Biotechnology
Ackerstrasse 71–76
13355 Berlin
Germany

Glenwyn Kemp
Dream Laboratory Ltd
Mulgrave Terrace
Gateshead NE8 1AW
UK

Arne Klingner
Technische Universität Braunschweig
Institute of Biochemical Engineering
Gaussstrasse 17
38106 Braunschweig
Germany

Sriram Kumaraswamy
ForteBio Inc.
Suite 201
1360 Willow Road
Menlo Park, CA 94025
USA

John Lewis
Crucell Holland BV
PO Box 2048
2301 CA Leiden
The Netherlands

Christopher R. Lowe
University of Cambridge
Institute of Biotechnology
Department of Chemical Engineering and Biotechnology
Tennis Court Road
Cambridge CB2 1QT
UK

Linda H.L. Lua
University of Queensland
UQ Protein Expression Facility
AIBN Building
Corner College and Cooper Roads
Brisbane, Queensland 4072
Australia

Alfred Luitjens
Crucell Holland BV
PO Box 2048
2301 CA Leiden
The Netherlands

Anton P.J. Middelberg
University of Queensland
Australian Institute for Bioengineering and Nanotechnology
Corner College and Cooper Roads
Brisbane, Queensland 4072
Australia

Nawin Mishra
University of South Carolina
Department of Biological Sciences
715 Sumter Street
Columbia, SC 29208
USA

Dethardt Müller
Rentschler Biotechnologie GmbH
Erwin-Rentschler-Strasse 21
88471 Laupheim
Germany

Thomas Müller-Späth
ChromaCon AG
Technoparkstrasse 1
8005 Zürich
Switzerland

Peter Neubauer
Technische Universität Berlin
Department of Biotechnology
Ackerstrasse 71–76
13355 Berlin
Germany

Matjaž Peterka
BIA Separations d.o.o.
Teslova 30
1000 Ljubljana
Slovenia
and
The Center of Excellence for Biosensors
Instrumentation and Process Control – COBIK
Velika pot 22
5250 Solkan
Slovenia

Thorsten Peuker
Sartorius Stedim Biotech GmbH
Schwarzenberger Weg 73–79
34212 Melsungen
Germany

Aleš Podgornik
BIA Separations d.o.o.
Teslova 30
1000 Ljubljana
Slovenia
and
The Center of Excellence for Biosensors
Instrumentation and Process Control – COBIK
Velika pot 22
5250 Solkan
Slovenia

Alain Pralong
Crucell Holland BV
PO Box 2048
2301 CA Leiden
The Netherlands

Kathrin Ralla
Technische Universität Berlin
Department of Biotechnology
Ackerstrasse 71–76
13355 Berlin
Germany

Laura Rowe
University of Cambridge
Institute of Biotechnology
Department of Chemical Engineering and Biotechnology
Tennis Court Road
Cambridge CB2 1QT
UK

Aleš Štrancar
BIA Separations d.o.o.
Teslova 30
1000 Ljubljana
Slovenia
and
The Center of Excellence for Biosensors
Instrumentation and Process Control – COBIK
Velika pot 22
5250 Solkan
Slovenia

Guido Ströhlein
ChromaCon AG
Technoparkstrasse 1
8005 Zürich
Switzerland

Jochen Strube
Clausthal University of Technology
Institute for Separation and Process Technology
Leibnizstrasse 15
38678 Clausthal-Zellerfeld
Germany

Detlev Szarafinski
Sartorius Stedim Biotech GmbH
August-Spindler Strasse 11
37079 Goettingen
Germany

Helmut Trautmann
abiotec AG
Buchenweg 21
4310 Rheinfelden
Switzerland

Achim Treumann
NEPAF
Devonshire Building
Devonshire Terrace
Newcastle upon Tyne NE1 7RU
UK

Roland Wagner
Rentschler Biotechnologie GmbH
Erwin-Rentschler-Strasse 21
88471 Laupheim
Germany

Omar M. Wahab
Sartorius Stedim Biotech GmbH
Purification Technologies
Spindler Strasse
Gottingen 37079
Germany

Part One
Upstream Technologies

1

Strategies for Plasmid DNA Production in Escherichia coli

Eva Brand, Kathrin Ralla, and Peter Neubauer

1.1 Introduction

DNA-based therapeutics has become an interesting and highly efficient solution for vaccination since its introduction in the 1990s by Wolff et al. (e.g., [1, 2]). Since then DNA vaccines have become a viable option to boost the host’s immune response for the treatment of bacterial and viral diseases (such as AIDS/HIV, Ebola, and malaria), as well as for the treatment of cancer [3, 4] and even for gene therapy [5]. Principally, DNA can be delivered by viral (generally adenovirus related) or nonviral vector systems. ...

Table of contents

• Cover
• Related Titles
• Volume 1
• Volume 2
• Index