Continuous Biomanufacturing
Description
Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
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Person
A chemistry graduate from Madras, India, Dr. Subramanian was awarded his doctorate from the University of Glasgow for work on natural products. His main research interests lie in the utilization of natural material separation processes and bioconversions.
Dr. Subramanian has written and edited a number of books and articles in the field of biotechnology. For the last 15 years, he has been organizing conferences promoting the integration and sharing of knowledge between academia and industry.
Content
2. Tools Enabling Continuous and Integrated Upstream and Downstream Processes in the Manufacturing of Biologicals
3. Engineering Challenges of Continuous Biomanufacturing Processes (CBP)
4. Progress Towards Automated Single Use Continuous Monoclonal Antibody Manufacturing via the Protein Refinery Operations Lab
5. Single-use bioreactors for continuous bioprocessing: challenges and outlook
6. Two mutually enabling trends: Continuous bioprocessing and Single-use technologies
7. Perfusion Formats and their specific medium requirements
8. Upstream Continuous Process Development
9. Study of Cells in the Steady State Growth Space
10. Continuous Downstream Processing for Production of Biotech Therapeutics
11. Evolving Needs For Viral Safety Strategies in Continuous Monoclonal Antibody Bioproduction
12. Multi-Column Continuous Chromatography ? Understanding this enabling Technology
13. Continuous Chromatography as a fully integrated process in Continuous Biomanufacturing
14. Continuous Chromatography in Biomanufacturing
15. Single Pass Tangential Flow Filtration (SPTFF) in Continuous Biomanufacturing
16. Design of Integrated Continuous Processes for high quality Biotherapeutics
17. Integration of upstream and downstream in continuous biomanufacturing
18. Quality control and regulatory aspects for continuous biomanufacturing
19. Continious Validation for Continous Processing
20. Validation, uality and Regulatory Considerations in Continuous Biomanufacturing
21. Evaluation of Continuous Downstream processing: Industrial Perspective
List of Contributors
Kristo Abner
Competence Center of Food and Fermentation Technologies
Akadeemia tee 15
12618 Tallinn
Estonia
Kaarel Adamberg
Tallinn University of Technology
Department of Chemistry and Biotechnology
Akadeemia tee 15
12618 Tallinn
Estonia
and
Competence Center of Food and Fermentation Technologies
Akadeemia tee 15
12618 Tallinn
Estonia
Harshit Agarwal
Indian Institute of Technology
Department of Chemical Engineering
Hauz Khas
110016 New Delhi
India
Paul Beckett
Millipore SAS
Process Solution Technologies
39 Route Industrielle de la Hardt
67124 Molsheim
France
Helge Berg
Technology Management
Millipore SAS
39 Route Industrielle de la Hardt
67124 Molsheim
France
Torsten Bisschop
Millipore SAS
Process Solution Technologies
39 Route Industrielle de la Hardt
67124 Molsheim
France
Marc Bisschops
Pall Life Sciences
Scientific Laboratory Services
Nijverheidsweg 1
1671 GC Medemblik
The Netherlands
Mathilde Bourguignat
Technology Management
Millipore SAS
39 Route Industrielle de la Hardt
67124 Molsheim
France
Mark Brower
Merck & Co Inc
Biologics & Vaccines
2000 Galloping Hill Road
Kenilworth, NJ 07033
USA
Rimenys J. Carvalho
Federal University of Rio de Janeiro
COPPE
Cell Culture Engineering Laboratory
C.P. 68502
21941-972 Rio de Janeiro, RJ
Brazil
Leda R. Castilho
Federal University of Rio de Janeiro
COPPE
Cell Culture Engineering Laboratory
C.P. 68502
21941-972 Rio de Janeiro, RJ
Brazil
Cedric Geyer
Technology Management
Millipore SAS
39 Route Industrielle de la Hardt
67124 Molsheim
France
Andrew Clutterbuck
Millipore SAS
Process Solution Technologies
39 Route Industrielle de la Hardt
67124 Molsheim
France
M. Nicolas Cruz-Bournazou
Technische Universität Berlin
Department of Biotechnology
Ackerstrasse 76
ACK 24
13355 Berlin
Germany
Michael A. Cunningham
Technology Management
EMD Millipore Corporation
290 Concord Road
Billerica, MA 01821
USA
Reinhard Ditz
Clausthal University of Technology
Institute for Separation and Process Technology
Leibnizstr 15
38678 Clausthal-Zellerfeld
Germany
Sten Erm
Tallinn University of Technology
Department of Chemistry and Biotechnology
Akadeemia tee 15
12618 Tallinn
Estonia
and
Competence Center of Food and Fermentation Technologies
Akadeemia tee 15
12618 Tallinn
Estonia
Guillermina Forno
Ciudad Universitaria
Cell Culture Laboratory
UNL
FBCB
Paraje el Pozo
CC 242 Santa Fe
Argentina
and
Ciudad Universitaria
R&D Zelltek S.A.
UNL
FBCB
Paraje el Pozo
CC 242 Santa Fe
Argentina
Paul Genest
Technology Management
EMD Millipore Corporation
290 Concord Road
Billerica, MA 01821
USA
Sanchayita Ghose
Bristol-Myers Squibb
Downstream Process Development
38 Jackson Road
Danvers, MA 01923
USA
Julie Grace
Pall Life Sciences
Scientific Laboratory Services
20 Walkup Drive
Westborough, MA 01581
USA
Petra Gronemeyer
Clausthal University of Technology
Institute for Separation and Process Technology
Leibnizstr 15
38678 Clausthal-Zellerfeld
Germany
Sanjeev K. Gupta
Ipca Laboratories Ltd.
Advanced Biotech Lab
Kandivli Industrial Estate
Kandivli (west)
400067 Mumbai
India
Josselyn Haas
Millipore SAS
Process Solution Technologies
39 Route Industrielle de la Hardt
67124 Molsheim
France
Daniel Karst
ETH Zurich
Institute for Chemical and Bioengineering
Department of Chemistry and Applied Biosciences
Vladimir-Prelog-Weg 1
8093 Zurich
Switzerland
Nikhil Kateja
Indian Institute of Technology
Department of Chemical Engineering
Hauz Khas
110016 New Delhi
India
Steven S. Kuwahara
GXP BioTechnology LLC
Tucson, AZ 85741
USA
Renato Lorenzi
Millipore SAS
Process Solution Technologies
39 Route Industrielle de la Hardt
67124 Molsheim
France
Kathleen Mihlbachler
Lewa Process Technologies Inc. Separations Development
8 Charlestown Street
Devens, MA 01434
USA
Massimo Morbidelli
ETH Zurich
Institute for Chemical and Bioengineering
Department of Chemistry and Applied Biosciences
Vladimir-Prelog-Weg 1
8093 Zürich
Switzerland
Thomas Müller-Späth
ChromaCon AG
Process Development
Technoparkstrasse 1
8005 Zurich
Switzerland
and
ETH Zurich
Institute for Chemical and Bioengineering
Department of Chemistry and Applied Biosciences
Vladimir-Prelog-Weg 1
8093 Zürich
Switzerland
Venkatesh Natarajan
Biogen
Engineering & Technology
225 Binney Street
Cambridge, MA 02142
USA
Peter Neubauer
Technische Universität Berlin
Department of Biotechnology
Ackerstrasse 76
ACK 24
13355 Berlin
Germany
Laura Okhio-Seaman
Sartorius Stedim North America
Validation Services
5 Orville Drive
Bohemia, NY 11716
USA
Nico M.G. Oosterhuis
Celltainer Biotech BV
Bothoekweg 9
7115AK Winterswijk
The Netherlands
Eduardo Ortí
Ciudad Universitaria
R&D Zelltek S.A.
UNL
FBCB
Paraje el Pozo
CC 242 Santa Fe
Argentina
John Pieracci
Biogen
Engineering & Technology
225 Binney Street
Cambridge, MA 02142
USA
David Pollard
Merck & Co Inc
Biologics & Vaccines 2000 Galloping Hill Road
Kenilworth, NJ 07033
USA
Anurag S.Rathore
Indian Institute of Technology
Department of Chemical Engineering
Hauz Khas
110016 New Delhi
India
Douglas Richardson
Merck & Co Inc
Biologics & Vaccines 2000 Galloping Hill Road
Kenilworth, NJ 07033
USA
Christian Schild
Merck Life Science (a business of Merck KGaA) Process Solutions
Cell Culture Media R&D
Frankfurter Strasse 250
64291 Darmstadt
Germany
Mark Schofield
Pall Life Sciences
Applications R&D
20 Walkup Drive
Westborough, MA 01581
USA
Andrus Seiman
Tallinn University of Technology
Department of Chemistry and Biotechnology
Akadeemia tee 15
12618 Tallinn
Estonia
and
Competence Center of Food and Fermentation Technologies
Akadeemia tee 15
12618 Tallinn
Estonia
Frederic Sengler
Millipore SAS
Process Solution Technologies
39 Route Industrielle de la Hardt
67124 Molsheim
France
Jochen B. Sieck
Merck Life Science (a business of Merck KGaA)
Process Solutions
Cell Culture Media R&D
Frankfurter Strasse 250
64291 Darmstadt
Germany
Fabian Steinebach
ETH Zurich
Institute for Chemical and Bioengineering
Department of Chemistry and Applied Biosciences
Vladimir-Prelog-Weg 1
8093 Zurich
Switzerland
Jochen Strube
Clausthal University of Technology
Institute for Separation and Process Technology
Leibnizstr 15
38678 Clausthal-Zellerfeld
Germany
Holger Thiess
Clausthal University of Technology
Institute for Separation and Process Technology
Leibnizstr 15
38678 Clausthal-Zellerfeld
Germany
Raivo Vilu
Tallinn University of Technology
Department of Chemistry and Biotechnology
Akadeemia tee 15
12618 Tallinn
Estonia
and
Competence Center of Food and Fermentation Technologies,
Akadeemia tee 15
12618 Tallinn
Estonia
Jörg von Hagen
Merck Life Science (a business of Merck KGaA) Process Solutions
Cell Culture Media R&D
Frankfurter Strasse...
