PPB05
Crete, Greece
May 9th - 12th, 2005
 
   

Final Program

Session 1| Session 2 |Session 3 | Session 4 | Session 5 | Session 6
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Updated May 1, 2005

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Monday May 09, 2005
 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
 Tuesday May 10, 2005
 Session 1 Product Developments and New Technologies 
Jan Over
08.30 - 08.35 Chairman´s Introduction
 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 
 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
 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
10.05 - 10.30   Coffee break
 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.
 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.
 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
   

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
17.30 - 17.35 Chairman´s Introduction
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
 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
 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.)
 18.50 - 19.15 Coffee break
 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.
 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.
 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 
   
Wednesday May 11, 2005
 Session 3 Manufacturing
Johan Vandersande
08.30 - 08.35 Chairman´s Introduction
 08.35 - 09.05 301 Computer-assisted plasma logistics
Gerold Zerlauth
Baxter AG, Plasma Control Europe, Vienna, Austria
 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 
 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.
 10.05- 10.30  Coffee Break
 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.
 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.
 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 
   

 17.00 - 17.30

Focus Lecture 2
TSE’s and Medicinal Products. Regulatory aspects in the EU.
Dr. Sol Ruiz, Spanish Medicines Agency, Madrid, Spain
   
 Session 4 Hyperimmune and Intravenous IgG
Wytold Lebing
17.30 - 17.55 Chairman´s Introduction
 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
 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
 18.45 - 19.15 Coffee break
 19.15 - 19.40 403 Purification of SARS Hyperimmune Globulins
Bing-Lou Wong, Yi-Wu Xie*, Advantek Biologics Limited, Hong Kong, R. O. China
 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
 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
   
 Thursday May 12, 2005
 Session 5 Pathogen Safety Issues
Bernard Horowitz
08.30 - 08.35 Chairman´s Introduction
 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
 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
 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
 09.50 - 10.20  Coffee break
 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
 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
 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.
 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
   
 Session 6 Applications of Plasma Products and Clinical Developments
Hubert Heinrichs
15.00 - 15.05 Chairman´s Introduction
 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
 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
 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
 16.20 - 16.45  Coffee break
 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
 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
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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