Final Program - PPB03


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Updated June 21, 2003


Tuesday April 22nd, 2003
 19.00-19.15 Welcome and Introduction, Queen´s Ballroom
Chairperson; Jan Berglöf, Sweden
 19.15-20.00 Keynote Lecture; Queen´s Ballroom
Plasma Protein Products, Opportunities for the Future
Jan Over, Sanquin Blood Supply Foundation, Division Plasma Products, Plesmanlaan 125, 1066 CX Amsterdam, The Netherlands
 20.00- Welcome Dinner; Pool Deck
Wednesday April 23rd, 2003 
  Session 1 Plasma Proteomics
Queen´s Ballroom
Chairperson; David Hammond, USA
 08.30-08.45 101 The Role of Mass Spectroscopy in Proteomics.
Timothy K. Hayes, Ph.D., Director of Analytical Chemistry for Plasma Derivatives, Jerome Holland Laboratory and Plasma Services, American Red Cross, Rockville, MD, USA 20855
08.45-09.15 102 Characterization of the Proteome by Novel Mass Spectrometric Approaches
Karin D. Rodland*, Josh Adkins, Joel Pounds, Richard Smith Protein Function Group, Pacific Northwest National Laboratory, Richland WA 99352
09.15-09.45 103 The Human Serum Proteome: Display Of Nearly 3,700 Chromatographically Separated Protein Spots On 2-DE Gels And Identification of 325 Distinct Proteins
Rembert Pieper*, Christine L. Gatlin, Anthony J. Makusky, Paul S. Russo, Courtney R. Schatz, Stanton S. Miller, Andrew M. McGrath, Marla A. Estock, Prashanth P. Parmar, Ming Zhao, Shih-Ting Huang, Jeff Zhou, John Taylor, Sandra Steiner, Large Scale Biology Corporation, Germantown, Maryland, U.S.A.
09.45-10.15 Coffee break
10.15-10.40 104 'Applications of Affinity Ligand Technology to Plasma Proteomics'
Steve Burton*, Dev Baines, Helen Tatton & Jim Pearson
Prometic Biosciences Ltd, 211, Cambridge Science Park, Milton Road, Cambridge, CB4 OZA, United Kingdom
 10.40-11.05 105 In Vitro Quantification of Disease Phenotypes: An Automated System for Drug Discovery
Kris F. Sachsenmeier1, Julia Tait Lathrop2, Jolly Sarkar2, Darrin W. Sabol1, Lorraine R. McKenzie1, and Lex M. Cowsert*1. 1Automated Cell, Inc., Pittsburgh, PA 15238, 2American Red Cross R & D, Rockville, MD
11.05-11.30 106 Functional Identification of Novel Activities - Mining the Plasma for New Therapeutic Proteins
Julia Tait Lathrop1*, Jolly Sarkar1, Anne McKeague1, Serguei Soukharev1, Lorraine R. McKenzie2, Kris F. Sachsenmeier2, Lex M. Cowsert2, and David J. Hammond1, 1Plasma Derivatives Department, Jerome Holland Laboratory for the Biomedical Sciences, American Red Cross Biomedical R&D., Rockville, MD 20855, and 2Automated Cell, Inc., Pittsburgh, PA, 15238.
11.30-12.00 Conclusions and discussion. David Hammond, USA

12.00-13.00
Lunch box
13.00-16.00 Walking tour of Willemstad and Otrobanda
17.00-17.30 Focus Lecture 1; Queen´s Ballroom
Safety of Blood and Blood Components for Transfusion in Latin America and the Caribbean
José Ramiro Cruz, Pan American Health Organization, Washington, D.C., USA
   
  Session 2 Pathogen and Prion Safety
Queen´s Ballroom
Chairperson; Bernard Horowitz, USA
17.30-17.50 201 Parvovirus B19 is Heat Sensitive under Specific Conditions - Is the Problem Solved?
Hannelore Willkommen, Clearant GmbH, Dreieich, Germany
17.50-18.10 202 Design of a Parvovirus Filtration Step for Plasma IgG
*Herb Lutz, Marty Siwak, Bayer Corp., Benesis Corp.
18.10-18.30 203 A New Reactor for Inactivating Viruses in Biotechnological and Pharmaceutical Processes
Klaus Kaiser*, Sebastian Schmidt, Jörg Kauling and Hans-Jürgen Henzler.Bayer Technology Services GmbH, Building 25, 42096 Wuppertal, Germany
18.30-18.55 Coffee break
18.55-19.15 204 Pathogen Inactivation Validation Using Nucleic Acid Testing Methods
Keith McKenney, Lidja Gillmeister, Kristina Marlowe, David Armistead, Wilson Burgess, and William Drohan*, Clearant, Inc., Gaithersburg, MD
19.15-20.05 205 Scrapie Removal by Gradiflow™ During the Purification of Plasma Proteins
Hari Nair* and Kailing Wang, Commercial Separations Divisions, Gradipore Ltd, 22 Rodborough Rd, Frenchs Forest NSW 2086, Australia. Contact hnair@gradipore.com
20.05-20.25 206 Functional Integrity of Intravenous Immunoglobulin Following Irradiation with a Virucidal Dose of Gamma Radiation
H. Tran1, K. Marlowe1, K. McKenney1, G. Petrosian1, Y. Griko1, W.
H. Burgess*, W. Drohan1, M. A. Imboden2, C. Kempf2, N. Boschetti2
and D. M. Mann1, 1Clearant, Inc., Gaithersburg, Maryland;
2ZLB Bioplasma AG Bern, Switzerland
20.25-20.45 207 Iodoacetaldehyde technology for virus inactivation.
Peder Bergvall*, Amersham Biosciences AB, Separations R&D, Uppsala, Sweden

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Thursday April 24th, 2003
  Session 3 Developments and New Technologies
Queen´s Ballroom
Chairperson; Christopher Bryant, USA
08.30-08.55 301 A New Process for the Preparation of Immunoglobulin G
Hari Nair*, Grace Li, David Meh#, Stewart Smith, Lucy Ryan, Rob Stewart, Kailing Wang and Christopher Bryant# Presented by R. Stewart
Gradipore Ltd, 22 Rodborough Rd, Frenchs Forest NSW 2086, Australia, #Aventis Behring, LLC, PO Box 511, Kankakee, IL 60901. * Contact hnair@gradipore.com
08.55-09.20 302 Plasmin Process Development
William R. Alonso, Chris Dadd, James Rebbeor, Jon Strauss, Michelle St Peter, Jeff Yuziuk, Marina Korneyeva, Chris Stenland, Bayer Corporation, Clayton, NC, 27511, USA
09.20-09.45 303 Use of Chromatographic Supports Based on Monoliths for Large Scale Purification of Clotting Factors VIII and IX
Djuro Josic1*, Andrea Buchacher1, Karmen Branovic2, Milos Barut3 and Alois Jungbauer4
1) Octapharma Pharmazeutika ProduktionsgesmbH, Vienna, AUSTRIA; 2) Institute of Immunology, Zagreb, CROATIA; 3) BIA Separations d.o.o., Laboratory and Process Equipment Company Ltd., Ljubljana, SLOVENIA; 4) Institute of Applied Microbiology, University of Agricultural Sciences, Vienna, AUSTRIA.
*fax: 0043/1/61032330, email: djuro.josic@octapharma.at
09.45-10.15 Coffee break
10.15-10.40 304 IgG Purification Using IEX Filter Technology
Peter Gomme1*; Vreni Förstch2; Susanne Gilgen2; Karl McCann1; Carole Schönmann2; Joe Bertolini1; Gerhard Hodler2.
1CSL Bioplasma 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia.
2 ZLB Bioplasma AG Wankdorfstrasse 10 3000 Bern 22 Switzerland
10.40-11.05 305 Cloned Transchromosomic Calves Producing Human Immunoglobulin
James M. Robl*1 and Isao Ishida 2, 1Hematech, LLC, Sioux Falls, SD 57106, USA, 2Pharmaceutical Research Laboratory, Kirin Brewery Co., Ltd., 3 Miyahara-cho Takasaki-shi Gunma 370-1295, Japan
11.05-11.30 306 Pulmonary Administration of Alpha1-Antitrypsin for the Treatment of Alpha1-Antitrypsin Deficiency.
*Romberg, VG1; Roskos, KV2; Stocks, J3; Brantly, M4
1Aventis Behring LLC, King of Prussia, PA, 2Inhale Therapeutics, San Carlos, CA. 3University of Texas Health Center at Tyler, TX, 4University of Florida College of Medicine, Gainseville, FL
11.30-12.00 Conclusions and discussion Christopher Bryant, USA
12.00 Lunch; Portofino
 
16.00-17.00 Poster Session; Queen´s Ballroom
17.00-17.30 Focus Lecture 2; Queen´s Ballroom
Plasma Fractionation in China and South East Asia.
Neil H.Goss, Further Options Pty. Ltd., 39 Glenard Drive, Eaglemont, Victoria 3084, phone: 61-3-9455-1283, fax: 61-3-9458-2838, cell: 61-411-958-130, e-mail: goss@mpx.com.au
  Session 4 Regulatory perspectives
Queen´s Ballroom
Chairperson; Mary Ann Lamb, USA
17.30-17.55 401 Current FDA CMC Regulatory Requirements for the Development of New Plasma Products: What To Do When?
Dr Nadine M. Ritter, Biotechnology Product Consultant
17.55-18.20 402 The Importance of Impurity Profiles for Plasma-derived Protein Products and New Technologies for their Characterization.
Timothy K. Hayes, Ph.D., Director of Analytical Chemistry for Plasma Derivatives, Jerome Holland Laboratory and Plasma Services, American Red Cross, Rockville, MD, USA 20855.
18.20-18.45 403  "Comparability Studies for Human Plasma-Derived Therapeutics: FDA's Perspective and Experience".
Andrew Chang, Ph.D.,Acting Deputy Director, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA, Rockville, MD
18.45-19.10  Coffee break
19.10-19.35 404 Safety of Plasma and Biotech Products: A European Regulatory Perspective
Hannelore Willkommen, Vice President Regulatory Affairs, Clearant GmbH, Germany
19.35-20.00 405 Complying with New Regulatory Expectations in the Field of Viral Validation
Dominique Pifat, Director of Virology, Kathryn M. Remington, Ph.D., Senior Staff Scientist, Pathogen Safety, Stephen R. Petteway, Jr. , Ph.D., Vice President Pre-Clinical Research and Pathogen Safety, Bayer HealthCare LLC, Biological
Products Division, Research Triangle Park, North Carolina
20.00-20.25 406 Reduction in the Duration of Quarantine for Fresh Frozen Plasma (FFP) from 6 to 4 Months in Germany : Recommendation of the Natl. Advisory Committee Blood ( Arbeitskreis Blut )
Reinhard Burger*, Max Delbrueck-Center for Molecular Medicine, and Robert Koch-Institute, Berlin, Germany.
20.25-20.30 Conclusions and discussion Mary Ann Lamb, USA


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Friday April 25th, 2003
  Session 5 Clinical Issues in Plasma Products
Queen´s Ballroom
Chairperson; Peter Späth, Switzerland
08.30-08.35 Introduction by chairperson
08.35-09.10 501 Immunomodulation of Autoimmune and Inflammatory diseases with Intravenous Immune Globulin
Srini V Kaveri and Michel D Kazatchkine, INSERM U430, Institut des Cordelieres, Paris France
09.10-09.45 502 Recombinant Adenoviruses used in Gene Therapy cause Massive Complement Activation via Antibody Induced in Previous Infections
Günter Cichon and Reinhard Burger*, Max Delbrueck-Center for Molecular Medicine, and Robert Koch-Institute, Berlin, Germany. Fax: + 49 30 45 47 - 2602 E-Mail address: BurgerR@rki.de
09.45-10.15  Coffee break
10.15-10.50 503 Nitric Oxide Scavengers in the Treatment of Shock Associated with Systemic Inflammatory Response Syndrome NOT PRESENT
Joseph De Angelo, Jens Kurth*, Curacyte AG Munich, Germany
10.50-11.25 504 Recombinant Anti-D Clears RhD-Positive Red Blood Cells and Prevents RhD Immunization in RhD Negative Male Volunteers
Bichler J, Amstutz HP, Martin R*, Spycher MO, Lerch P, Miescher S. ZLB Bioplasma AG, Bern, Switzerland Presented by P. Spaeth
11.25-12.00 505 Reconstituted HDL, a Novel Drug for Acute Cardiovascular, Cerebrovascular, and Inflammatory Diseases
Peter Lerch*, Alphonse Hubsch, Stefanie Koch, Roland Martin, Bernhard Spörri, ZLB Bioplasma AG, Bern, Switzerland Presented by P. Spaeth
12.00  Lunch; Portofino

Session 6 Manufacturing Perspectives
Queen´s Ballroom
Chairperson; Johan Vandersande, USA
15.00-15.30 601 Concept of Viral Zoning in a Multi-Product Facility
Ernst Hetzl, Baxter BioScience, Benatzkygasse 2-6, A-1220 Vienna, Austria
15.30-16.00 602 Manufacturing Fast Track Hyperimmunes to meet urgent needs
William Labossiere Bees, Cangene Corp., Winnipeg, Manitoba, Canada
Fax number: (204) 269-7003 E mail: bbees@Cangene.com
16.00-16.25 603 Plans for Construction of a Plasma Fractionation Plant in Brazil
Isaias Raw, Elizabeth A. L. Martins, Hisako H. Gondo, Davidson Rebecci
Division of Development of Products and Process and Divion of Production, Instituto Butantan - São Paulo ­ SP
16.25-16.50 Coffee break
16.50-17.20 604 A New Process for the Purification of Alpha-1 Proteinase Inhibitor
Wytold Lebing*, Susan Trukawinski, Woody Wood, David Ownby$, and Mark Chavez$
Bayer Corporation, Clayton, NC, 27511, USA, $Diosynth RTP, Inc., Cary, NC 27513, USA
17.20-17.50 605 Large-Scale Manufacture of Alpha-1-Acid Glycoprotein for Clinical Use
David R. Lewin*, Jacky Rott, John E. More.
Bio Products Laboratory, Dagger Lane, Elstree, Herts, WD6 3BX. England.
Tel No. +44(0)2082582325 Fax No. +44(0)2082582617 e-mail david.lewin@bpl.co.uk
17.50-18.20 606 Development of Nanogram. a New Virus-Filtered Liquid IVIG Product
J. Parkkinen*, H. Tölö*, H. Suomela*, E. Törmä*, A. Koenderman$, H. ter Hart$, H. Eijkhout$, F. van Engelenburg$
*Finnish Red Cross Blood Transfusion Service (FRC BTS), Kivihaantie 7, FIN-00310, Helsinki, Finland, $ Sanquin Blood Supply Foundation, Division Plasma Products, PO Box 9190, 1006 AD, Amsterdam, The Netherlands.
18.20-18.30  Conclusion of the meeting
19.30 Caribbean Night Dinner; On the Beach

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  Posters
Queen´s Ballroom
Wednesday - Friday
701 Characterisation of ECH-Lysine Sepharose 4 Fast Flow - a New Affinity Chromatography Support
Ingela Blomqvist, Thomas Ekström, Jan Gustavsson, Helena Westergren, Anna Mattsson, Maria Erikhans and Inger Lagerlund*, Amersham Biosciences, SE 75184 Uppsala, Sweden and Zuzana Valnickova, Department of Molecular and Structural Biology, University of Aarhus, Denmark.
702 Recovery of IgG from Ethanol Precipitates of the Cohn-Oncley and Kistler-Nitschmann Fractionation Schemes
John Curling*, Dev Baines, Crystal Russell, Keith Watson, Emma Ward, Hannah Pollard & Steve Burton, ProMetic BioSciences Ltd., 211 Cambridge Science Park, Cambridge CB4 0ZA, UK.
703 Triple Affinity Columns Package for One Step High Purification of the alpha-2-Plasmin Inhibitor and Histidine-Rich Glycoprotein Directly from Human Plasma.
Tatiana V. GRINENKO, Georgiy L. VOLKOV*, Olena S. HAVRILIUK, Olena I. YUSOVA, Marina B. ZADOROZHNAYA
Palladin Institute of Biochemistry of the NAS of Ukraine, *Application and Training Laboratory of Amersham Biosciences Representative Office in Ukraine
704 An ELISA Method for Monitoring IgA Levels in IgG Preparations
V. Gurevich, K. McCann, K. Lyons, J. Bertolini*
CSL Bioplasma, 189-209 Camp Rd, Broadmeadows, Victoria, 3047, Australia.
705 The Effect of Tracer Ions on HETP Determination
K. McCann, P.Gomme*, L. Fernandez, B. Hunt, J. Bertolini
CSL Bioplasma, 189-209 Camp Rd, Broadmeadows, Victoria, 3047, Australia.
706 Investigation of Nanofiltration Flux Rates with Plasma Derived Proteins
Peter Gomme*; Sharon Vyas; Liza Fernandez; David Eakins; Joe Bertolini.
CSL Bioplasma 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia.
707 Proteins Under Pressure - Shear Damage to Proteins
A. Johnston1, P. Gomme, O.Tatford, D. Dunstan2 , J. Bertolini*1
CSL Bioplasma 189-209 Camp Road, Broadmeadows, Victoria, Australia, 30471, CRC for Bioproducts, University of Melbourne University, Parkville, Australia,30522
708 "Size Exclusion Filtration to Remove TSE Infectious Particles from a Model Protein Stream Using Composite Membrane"
Vincent Pizzi(1), Robert Blanck*(1), Christopher Stenland (2), Jarrett Terry (2), Kang Cai (2) , Richard Rubenstein (3), Michel Fournel(2), Douglas C. Lee (2), Stephen Petteway(2), (1) Millipore Corp. (2) Bayer Corp (3) Dept. of Virology NY State Institue for Basic Research in Developmental Disabilities
709 Storage Study Performed on Immunoglobulin G in Solution
I. Andersson, L-O. Lindquist, C. Sund Lundström, Amersham Biosciences, Uppsala, Sweden
710 Continuing Production of a Chromatographic Purified Strategic Product - Human Albumin 5% Over 20 Years NOT PRESENT
Olga Damevska Todorovska*, P. Kolevski, V. Stefanovska
Institute of Blood Transfusion,Medical Faculty, University "St. Cyrilus and Methodius" 1000 Skopje, Vodnjanska 17 Republic of Macedonia e-mail: olgadamevska@mt.net.mk
711 Quality Assurance of Transfer Factor: Strategy for Guarantee the Safety of a Blood Derivative. NOT PRESENT
K Sánchez*, A Quintana, F Porrero, MA Tuñón, E Noa, I Ruibal, Y Alvarez, A Rodríguez, K Cosme, P Porrero and W Díaz.Center of Genetic Engineering and Biotechnology. 31 Avenue between 158 and 190 streets, PO Box 6162, Cubanacán, Playa, Ciudad de la Habana, Cuba. PC 10600 E-mail: kosara.sanchez@cigb.edu.cu
712 Evaluation of Decreasing the Titer of Enveloped Viruses by Use of Solvent/Detergent in FVIII Prepared with Glycine. NOT PRESENT
Dr, T.Zandieh ; Dr, M.Farhadi; Dr, M.Shahrabadi.Iranian Blood Fractionation & Research co, Tehran.
713 INACTINE™ PEN110 and Solvent/Detergent: Two Orthogonal Virus Inactivation Methods
John Chapman*, Asa Ohagen, Veronica Gibaja, Jennifer Marcello, Douglas Lunderville, Jeff Horrigan and Aris Lazo. V.I. Technologies, Inc., Watertown, MA 02472, USA.
* phone 617-926-1551; fax 617-923-2318; john.chapman@vitechnologies.com 
714 A Study of the Purification Process of Nanotiv (factor IX)
Anna Mjärdestam, Peter Aizawa, Robert Marschall, Christina Leo, Stefan Winge, Octapharma AB, Stockholm, Sweden, E-mail: Stefan.Winge@octapharma.se
715 Parameters Important for the Effective Usage of a Nanofiltration Step
Stefan Winge, Octapharma AB, Stockholm, Sweden, E-mail: Stefan.Winge@octapharma.se 
716 Use of Llama Antibody Fragments as Ligands in Affinity Chromatography.
Pim Hermans*; Biotechnology Application Centre BV, The Netherlands
717 Methods for the Removal of INACTINE™ and Analysis of INACTINE™ at Trace Level Concentrations
Inger Andersson, Stefan Eriksson*, Ola Lind and Peder Bergvall, Amersham Biosciences, Separations R&D, SE-75184 Uppsala, Sweden
718 iProMx™: A New Concept in the Control and Monitoring of Production Processes
Brendan J. Murray1, Daniel Liebhart2 and Neil H.Goss*3,
1.Avalis AG, 2.Aseantic-Liebhart AG and 3.Further Options Pty. Ltd., 39 Glenard Drive, Eaglemont, Victoria 3084, phone: 61-3-9455-1283, fax: 61-3-9458-2838, cell: 61-411-958-130, e-mail: goss@mpx.com.au
719 Intravenously Applied IgG Stimulates Complement Attenuation in Dermatomyositis at the Amplifying C3 Convertase Level
Hans U. Lutz*1, Pia Stammler1, Valentina Bianchi1, Ralph M. Trüeb2, Thomas Hunziker3, Reinhard Burger4, Emiliana Jelezarova1, Peter J. Späth5
1) Institute of Biochemistry, Swiss Federal Institute of Technology, ETH-Hönggerberg, CH-8093 Zurich, Switzerland; 2) Department of Dermatology, University Hospital of Zurich, CH-8091 Zurich, Switzerland; 3) Department of Dermatology, Inselspital, CH-3010 Berne, Switzerland; 4) Robert Koch Institut, Nordufer 20, D-13353 Berlin, Germany; 5) ZLB Bioplasma AG, CH-3000 Berne-22, Switzerland.
720 Characterization of Recombinant Human Serum Albumin using Ettan™ MALDI-ToF Pro
J. Flensburg & M. Belew *, Amersham Biosciences, SE-751 84 Uppsala, Sweden

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