Final
Program
Session 1| Session
2 |Session 3 | Session
4 | Session 5 | Session
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Updated May 1, 2005
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Structure
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Monday May 09, 2005 |
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19.15-20.00 |
Keynote Lecture;
"Plasma Protein Products: how far have
we come, how far do we go?"
Dr. Graham D. Sher,
Chief Executive Officer, Canadian Blood Services, Ottawa, ONT,
Canada |
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Tuesday May 10, 2005 |
Session 1 Product Developments
and New Technologies
Jan Over |
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08.30 - 08.35 |
Chairman´s Introduction |
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08.35 - 09.05 |
101 Purification of plasma derived Mannose Binding Lectin
(MBL)
Antje Daehler * 1,4, Teresa Martinelli 1,4, Robert Pike 3,4,
Robyn Minchinton 2,4
1 CSL Bioplasma, 2 Australian Red Cross Blood Service, 3 Department
of Biochemistry & Molecular Biology, Monash University and
4 Cooperate Research Centre for Vaccine Technology |
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09.05 - 09.35 |
102 Fibrin Microbeads (FMB) for Autologous Tissue
Regeneration
Gerard Marx*, Anna Hotovly-Solomon, Ibrahim Kassis, Lila Levdansky,
Elena Gaberman and Raphael Gorodetsky
HAPTO Biotech Ltd., Jerusalem, Israel |
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09.35 - 10.05 |
103 Use of X-Ray Photoelectron Spectroscopy for the Direct
Assessment of Chromatographic Resin Cleaning
K. Lyons1*, G Seneviratne1, N Brack2, P.J. Pigram2 and J Bertolini1
1CSL Bioplasma, 189-209 Camp Rd, Broadmeadows Vic 3047 Australia
2Centre for Materials and Surface Science and Department of Physics,
La Trobe University Vic 3086 Australia |
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10.05 - 10.30 |
Coffee break |
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10.30 - 11.00 |
104 A new, high yielding, affinity cascade for sequential
isolation of plasma proteins of therapeutic value.
Christopher Bryant*1, Dev Baines1, Ruben Carbonell2, Tom Chen3,
John Curling1, Timothy Hayes3, Steve Burton1, and David Hammond3.
1 ProMetic BioSciences Ltd., Cambridge, UK, 2 North Carolina
State University College of Engineering, Raleigh NC, USA, 3 American
Red Cross, Plasma Derivatives, Gaithersburg, MD, USA. |
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11.00 - 11.30 |
105 New adsorbents for selective capture of plasma
proteins from recovered and source plasma.
Dev Baines*1, Jason Betley1, Ben Beacom1 Tom Chen2, Timothy Hayes2,
Jim Pearson1, and Pilar Vazquez1
1 ProMetic BioSciences Ltd., Cambridge, UK, 2 American Red Cross,
Plasma Derivatives, Gaithersburg, MD, USA. |
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11.30 - 12.00 |
106 The Application of CaptureSelect Affinity Ligands for
Purification of Plasma and Recombinant Plasma Products.
Laurens N. Sierkstra, Mark ten Haaft, Pim Hermans., B.A.C. Naarden,
The Netherlands |
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17.00 - 17.30 |
Focus Lecture 1
Comparability Protocols, FDA´s
Perspective and Experience
Dr. Andrew Chang
Div Hematology, FDA, Rockville, MD, USA |
Session 2 Recombinant
Plasma Proteins
Joe Bertolini |
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17.30 - 17.35 |
Chairman´s Introduction |
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17.35 - 18.00 |
201 Identification and Production of Recombinant Human Polyclonal
Antibody Drugs Reflecting the Natural Human Antibody Diversity
Søren Bregenholt, Symphogen A/S, Elektrovej 375, DK-2800
Lyngby, Denmark, presented by A Jensen |
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18.00 - 18.25 |
202 Transgenic goats and cows for the production of human
plasma proteins
Yann Echelard*, Harry M. Meade
GTC Biotherapeutics, Inc., 5 the Mountain Rd, Framingham, MA
01701, USA |
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18.25 - 18.50 |
203 Purification of rHSA on a pilot scale
Bo Ersson*, Mikael Berg, Joergen Samuelsson, Karin Caldwell (Center
for Surface Biotechnology, Uppsala University), Makonnen Belew,
Lise Lundh, Lars-Olof Lindquist (GE Helthcare), Li Mei Yan, Zhang
Wei, Wei Jing-Shuang, Du Li, Jia Qian (North China Pharmaceutical
Group Corp.) |
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18.50 - 19.15 |
Coffee break |
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19.15 - 19.40 |
204 In-depth Structural Characterisation can Expedite
the Development Process of Plasma Products and their Substitutes
Nicolas Bihoreau, Emmanuel Nony, François Fenaille, Laurent
Siret *, Sami Chtourou.
Laboratoire français du Fractionnement et des Biotechnologies,
Preclinical Development, 3 avenue des Tropiques, BP305, les Ulis,
91958 Courtaboeuf cedex, France. |
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19.40 - 20.05 |
205 Phage Display to Identify Recombinant Proteins as Potent
and Selective Proteinase Inhibitors
Mark de Souza, Ph.D.*, Sr. Director, Corporate Development, Dyax
Corp., 300 Technology Sq., Cambridge, MA 02139. USA. |
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20.05 - 20.30 |
206 Development of Recombinant Human Thrombin as an
Aid to Hemostasis in Subjects Undergoing Surgery
Jan Ohrstrom, MD*; John Forstrom, PhD; Linda Zuckerman, PhD;
Thomas Reynolds, MD, PhD
ZymoGenetics, Inc.; Seattle, WA |
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Wednesday May 11, 2005 |
Session 3 Manufacturing
Johan Vandersande |
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08.30 - 08.35 |
Chairman´s Introduction |
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08.35 - 09.05 |
301 Computer-assisted plasma logistics
Gerold Zerlauth
Baxter AG, Plasma Control Europe, Vienna, Austria |
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09.05 - 09.35 |
302 Chromatographic purification of Immunoglobulins at CSL
Bioplasma; A manufacturing perspective
John Lontos
CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria, 3047,
Australia |
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09.35 - 10.05 |
303 Technology Transfer: practical answers to practical issues
Andrea Morelli
Kedrion S.p.A., via Provinciale 1, 55027 Bolognana, Gallicano
(Lucca), Italy. |
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10.05- 10.30 |
Coffee Break |
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10.30 - 11.00 |
304 A comparative study of Cohn and chromatographic
fractionation using a novel affinity "Cascade Process".
John Curling*1, Dev Baines1, Christopher Bryant1, Ruben Carbonell2,
Tom Chen3, Patrick Gurgel2, and Timothy Hayes3.
1 ProMetic BioSciences Ltd., Cambridge, UK, 2 North Carolina
State University College of Engineering, Raleigh NC, USA, 3 American
Red Cross, Plasma Derivatives, Gaithersburg, MD, USA. |
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11.00 - 11.30 |
305 Investigating the effect of pumping
on plasma proteins
Peter T. Gomme*; Owen C. Tatford; Anna Johnson(1); Joe Bertolini.
CSL Bioplasma 189-209 Camp Road, Broadmeadows, Victoria 3047,
Australia; (1)Current address - CSIRO Food and Health Sciences,
343 Royal Parade, Parkville, Victoria 3052, Australia. |
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11.30 - 12.00 |
306 Aseptic filling of human albumin solution into flexible
container provides various opportunities for cost savings.
Theodor Langer, Baxter, Industriestrasse 17-19, 1220 Vienna,
Austria |
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17.00 - 17.30 |
Focus Lecture 2
TSEs and Medicinal Products. Regulatory
aspects in the EU.
Dr. Sol Ruiz, Spanish Medicines Agency, Madrid, Spain |
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Session 4 Hyperimmune and
Intravenous IgG
Wytold Lebing |
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17.30 - 17.55 |
Chairman´s Introduction |
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17.55 - 18.20 |
401 Production of a Virally Safe Despeciated
Equine Botulinum Antitoxin Product
Hugh Price*, Bill Bees, Lori Soluk and Andrew Griffiths
Cangene Corporation, 104 Chancellor Matheson Rd, Winnipeg, Manitoba,
Canada, R3T 5Y3 |
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18.20 - 18.45 |
402 Immunoregulation Of Transplant Rejection using
Intravenous Immunoglobulin
John Underwood1 Brian Tait2 Joe Bertolini*3 Fiona Hudson2 Paul
Licciardi1 Kyle Wilcox1
Department of Pathology, University of Melbourne1, Victorian
Transplantation and Immunogenetics Service, Australian Red Cross
Blood Service2 and CSL Bioplasma Division, CSL Ltd3 |
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18.45 - 19.15 |
Coffee break |
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19.15 - 19.40 |
403 Purification of SARS Hyperimmune Globulins
Bing-Lou Wong, Yi-Wu Xie*, Advantek Biologics Limited, Hong Kong,
R. O. China |
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19.40 - 20.05 |
404 A High-Yield IVIG Process with Efficient Viral Clearance
Jaakko Parkkinen*, Anne Rahola, Leni von Bonsdorff, Hannele Tölö,
Esa Törmä
Red Cross Finland Blood Service, Kivihaantie 7, FI-00310 Helsinki,
Finland |
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20.05 - 20.30 |
405 Emerging Technology in Hyperimmune Therapeutic Manufacturing
Wolfgang Ruesseler* Corporate VP Life Manufacturing, Life Therapeutics
Kailing Wang Corporate VP Life Bioprocess, Life Therapeutics,
736 Park North Blvd, Suite 100, Clarkston, Georgia 30021, USA |
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Thursday May 12, 2005 |
Session 5 Pathogen Safety
Issues
Bernard Horowitz |
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08.30 - 08.35 |
Chairman´s Introduction |
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08.35 - 09.00 |
501 Practical aspects of a prion clearance study
Dr. Olaf Stamm, NewLab BioQuality AG, Max-Planck-Str. 15A
, 40699 Erkrath, Germany
eMail: stamm@newlab.de |
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09.00 - 09.25 |
502 Filtration Technologies for Prion Removal
from Plasma Products
Jerold Martin, Sr. V.P., Global Technology Director, BioPharmaceuticals,
Pall Life Sciences, 2200 Northern Blvd., East Hills, NY 11548
USA |
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09.25 - 09.50 |
503 Application of Filtration Technologies for
Prion Removal from Plasma Product Intermediates
H. Pham1, W. Seyfert-Brand2, M. Alaveras1, T. Wiegand2, O. Gnau2,
W. Schäfer2, A. Gröner2 & T. Martinelli1
1 Research & Development, CSL Bioplasma, Melbourne, Australia,
2 Virology Department, ZLB Behring, Marburg, Germany |
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09.50 - 10.20 |
Coffee break |
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10.20 - 10.45 |
504 Validation and technological aspects of an integrated
virus clearance platform
Klaus Tarrach, Senior Product Manager Purification Technologies,
Sartorius AG, Biotechnology Division, Germany |
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10.45 - 11.10 |
505 Development of an in vitro TSE infectivity
assay: application to validation of manufacturing processes
B.Flan*1, G Le Hir1, B.You1, H.Laude2, JT Aubin1
LFB, Laboratoire Français du Fractionnement et des Biotechnologies,
3 ave des Tropiques - BP 305, Les Ulis, 91958 Courtaboeuf, France
2 INRA Jouy en Josas, France |
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11.10 - 11.35 |
506 Strategies for the Removal of Blood-Borne TSE Infectivity
David Hammond, American Red Cross, Steve Burton, ProMetic BioSciences,
Ruben Carbonell, North Carolina State University, Robert Rohwer,
University of Maryland. |
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11.35 - 12.00 |
507 Detection of PrPSc with PrPSc Specific Binding
Reagents without Proteinase K Treatment
M. Michelitsch, D. Peretz, M. Connolly, R. Zuckermann, C. Gao,
X. Wang, J. Hall, T. Horn, A. Gyenes, B. Shimizu, D. Dodge, B.
Phelps, C. Hu, and Y. Yang
Blood Testing Business Unit, Chiron Corporation, Emeryville,
CA, USA |
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Session 6 Applications of
Plasma Products and Clinical Developments
Hubert Heinrichs |
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15.00 - 15.05 |
Chairman´s Introduction |
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15.05 - 15.30 |
601 Biochemical and Pre-clinical Characterization of a New
10% Liquid Triple Virally Reduced Human Intravenous Immune Globulin
(IGIV, 10% TVR)
Wolfgang Teschner*1, Harald Arno Butterweck1, Wilfried Auer2,
Eva Maria Muchitsch2, Alfred Weber3 and Hans-Peter Schwarz4
1Baxter AG, Industriestr. 131, A-1220 Vienna; 2 Baxter AG Industriestr.
20, A-1220 Vienna;
3 Baxter AG, Benatzkygasse 2 -6, A-1220 Vienna, 4 Baxter AG,
Wagramerstr. 17 - 19 |
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15.30 - 15.55 |
602 Efficacy and Safety of Subcutaneous Immunoglobulin Replacement
Therapy at Home in Patients with Primary Immunodeficiency Diseases:
Combined Analysis of two Clinical Studies, one in North America
and one in Europe
Peter Kiessling1*, Hans D. Ochs2, Michael Borte3, Michaela Praus4
and Hubert Heinrichs1 ZLB Behring GmbH, Marburg, Germany, 2Department
of Pediatrics, University of Washington, Seattle, WA, United
States, 3Department of Pediatrics, Municipal Hospital "St.
Georg", Leipzig, Germany, 4Biostatistics, Covidence GmbH,
Marburg, Germany |
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15.55 - 16.20 |
603 Effective Prevention of Ischemia-Reperfusion
Injury with Plasma Proteins.
Jaakko Parkkinen
Red Cross Finland Blood Service, Kivihaantie 7, FI-00310 Helsinki,
Finland |
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16.20 - 16.45 |
Coffee break |
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16.45 - 17.15 |
604 WILFACTIN® - Development and Clinical evaluation
of a triple-secured and high-purity von Willebrand factor concentrate
Z.TELLIER* Laboratoire français du Fractionnement
et des Biotechnology - Les Ulis - France |
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17.15 - 17.40 |
605 Successful Treatment with Sandoglobulin in
Patients with Guillain-Barré Syndrome
Irmgard Andresen, MD, Clinical Research ZLB Behring AG, Berne
Switzerland |
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Poster list |
701 Development of a method to detect contaminant
proteins in Immunoglobulin G preparations ¡V A proteomics
approach
Peter Gomme 1; Judith Lysaght 2; Bernie McInerney 2; J. Bertolini
1
1CSL Bioplasma 189-209 Camp Road, Broadmeadows, Victoria 3047,
Australia; 2Australian Proteome Analysis Facility, Level 4 Building
F7B, Macquarie University, North Ryde, NSW 2109, Australia |
702 An abbreviated affinity chromatography Cascade
Process for FVIII/von Willebrand Factor Complex and Immunoglobulin
G.
Tom Chen*1, Sonday Allen1, Dev Baines2, Jason Betley2, Davida
Blackman1, Timothy Hayes1, Guy Harris2, Bastian Lobezoo2 and
Keith Watson2. 1 American Red Cross, Plasma Derivatives, Gaithersburg,
MD, USA, 2 ProMetic BioSciences Ltd., Cambridge, UK. |
703 A combined proteomics and well-characterised
approach to comparability for the development of cascade-fractionated-
and other plasma-derived products.
Timothy Hayes*1, Tom Chen1, Dev Baines2, Tom Busby1, Kevin Carrick1,
Dale Schmidt1, and Nadine Ritter3.
1 American Red Cross, Plasma Derivatives, Gaithersburg, MD, USA,
2 ProMetic BioSciences Ltd., Cambridge, UK, 3 Biological Consulting
Group, Alexandria VA, USA. |
704 Manufacturing Processes of Plasma-Derived
Products Reduce Emerging Pathogens
Albrecht Gröner, ZLB Behring GmbH, Marburg, Germany |
705 Screening of industrial plasma by HBV NAT:
Increase in viral safety?
G. Zerlauth* and M. Gessner, Baxter AG, Plasma Control Europe,
Vienna, Austria |
706 Study on the rHSA Quality specification
New drug R&D center, North China Pharmaceutical Group
Corp.
Jia Qian, Meiyan li and Xingjun Zhou etal |
707 Study on Serological Reaction to SARS-CoV of IVIG
and Original Plasma from Qualified Donors
Guo Zhongping, Wang Yu, Gou Hongtao et al, Chengdu Rongsheng
Pharmaceutical Co.,Ltd, Waidong Baojiang Bridge 610023, Chengdu,
Sichuan, P R of China |
708 Characterization of IgG fragments in liquid
intravenous immunoglobulin products
Robert V. Diemel 1,2, Hendricus G.J. ter Hart 2, Gerardus J.A.
Derksen 2, Anky H.L. Koenderman* 2 and Rob C. Aalberse 1
1 Sanquin Research, 2 Sanquin Plasma Products, Sanquin Blood
Supply Foundation, Amsterdam, The Netherlands |
709 Characterization of Plasminogen Removal Gel
Ingela Blomqvist, Inger Lagerlund*, Anna Mattsson, Amersham Biosciences,
Uppsala, Sweden & Roberto Meidler, Israel Nur, Omrix Biopharmaceuticals
Inc., Rehovot, Israel |
710 Removal of viruses and pathogen agents in
the down stream processing of plasma and biopharmaceutical products
by nanofiltration with Planova® filter
S. Vynck1) , E. Kederer1) , H. Hisada2) , T. Sato2)
1) Asahi Kasei Planova Europe, Brussels 2) Asahi Kasei Pharma
Corporation, Japan |
711 Advantages of the EBA method for the
first stage chromatography plasma proteins re-purification
G.L. VOLKOV*, S.I. Andrianov, A.Yu. SLOMINSKIY, O.S. HAVRYLYUK,
T.V. GOROSHNIKOVA
Palladin Institute of Biochemistry of the NAS of Ukraine, *Application
and Training Laboratory of Amersham Biosciences Representative
Office in Ukraine. Leontovicha str.,9, 01601, Kyiv, Ukraine. |
712 Plasma Economics -a brighter outlook
in the short term but changing fundamentals suggest future challenges-
Rosemary Cummins, Equity Research, Citigroup, Melbourne, Australia |
713 ELECTROPHORETIC ANALYSIS OF CLOTTING FACTOR
VIII CONCENTRATES
Odinokova, N.V., Azhigirova, M.A., Khametova, R.N.
National Research Centre of Haematology, Moscow, Russia |
714 The possibility of one-stage clotting method
for determination of factor VIII activity in the purefied antihaemophilic
concentrates.
A. Berkovskiy*, E. Sergeeva, A. Suvorov, M. Ajiguirova, A. Vorobiov.
Hematology Centre, Moscow, Russia. |
715 Is Citrate Deficiency A Common Problem in
Transfusion Medicine? Withdrawn
Edward Shanbrom(1), William J Owens(2)*
(1) Santa Ana, CA USA. (2) University of California, Irvine,
Orange CA. |
716 Blood Bank Preparation of Safe Immunoglobulin
Concentrate Withdrawn
Edward Shanbrom(1), William J Owens(2)*
(1) Santa Ana, CA. (2) University of California Irvine, Orange,
CA, USA. |
717 Innovative Method for Producing Therapeutic
Proteins in Plants
Kimmo Koivu 1, Timo Virkajärvi*2
1 UniCrop Ltd, Helsinki, Finland, 2 Rintekno Oy, Espoo, Finland |
718 UVivatec - A Scalable Technology for UV Virus
Inactivation in Laboratory and Production
Dr. Sebastian Schmidt*, DI Markus Zamponi, DI Jörg Kauling
Bayer Technology Services GmbH, D-51368 Leverkusen, Germany |
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