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Final Program - PPB03

Session 1| Session
2 |Session 3 | Session
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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 |
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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 |
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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 |
To the top
Thursday April 24th, 2003 |
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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 |
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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 |
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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 |
To the top
Friday April 25th, 2003 |
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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 |
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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 |
To the top
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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