Updated June 28, 2001
| 19.15-20.00 |
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Session 1; Research and novel technologies Chairman; Jan Over |
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| 08.30-08.35 | Chairman´s Introduction | |
| 08.35-09.00 |
101 |
Affinity-based
methods for blood plasma fractionation. Curling, J. M.1), Burton, S. J.2), and Perrault, R. A.3) 1) John Curling Consulting AB, Uppsala, Sweden, 2) ProMetic BioSciences Ltd., Cambridge, UK, 3) ProMetic BioSciences Inc., Montreal, Canada. |
| 09.00-09.25 | 102 |
The Gradiflow:
A novel technology for the separation of macromolecules
Hari Nair* and Andrew Gilbert Gradipore Ltd, PO Box 6126 Frenchs Forest, NSW 2086, Australia |
| 09.25-09.50 | 103 |
Mannan-binding
lectin, a new plasma product, production process and clinical
perspectives Inga Laursen, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark |
| 09.50-10.15 | 104 |
Development of
IPM/Cyplex as Platelet Substitute A.J.Verhoeven*)1, P.M.Hilarius1, D.C.Schotanus1, G.Escolar2, and M.Gendreau3 1CLB Sanquin, Amsterdam, The Netherlands; 2Hospital Clinico, Barcelona; 3Cypress Bioscience Inc., La Jolla CA, USA. Fax: 31-20-5123310; e-mail: a_verhoeven@clb.nl |
| 10.15-10.45 | Coffee Break | |
| 10.45-11.10 | 105 |
A Rapid Procedure
for Monitoring Alterations to Plasma Protein Structure using
Differential Scanning Calorimetry and Circular Dichroism P.T. Gomme; P. Thomas; N.H. Goss; J. Bertolini. CSL Bioplasma 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia |
| 11.10-11.35 | 106 |
Virus inactivation
using new or reviving techniques C. Kempf and F. Käsermann ZLB Bioplasma AG, Bern and Dept. Of Chemistry and Biochemistry, University of Bern, Switzerland |
| 11.35-12.00 | 107 |
SUPERFLUIDS(TM) CFI VIRUS INACTIVATION TECHNOLOGY Dr. Trevor P. Castor, Aphios Corporation, 3-E Gill Street, Woburn, MA 01810, USA, Tel: (001) 781-932-6933 Fax: (001) 781-932-6865, Web Site: www.aphios.com E-mail: aphios@aol.com |
| 12.00 Lunch | ||
|
Session 2; Development Chairman; David Naveh |
||
| 17.00-17.25 | 201 |
Introductory talk
concerning the changing plasma market and the role of new product
development. David Naveh, Bayer Corporation, USA |
| 17.25-17.50 | 202 |
Quixil(R) a human
Fibrin sealant containing a high concentration of multimeric
fibrinogen: optimization of components and efficacy in animal
models. By: Israel Nur and Liliana Bar.Omrix Biopharmaceuticals, SA. R&D. Belgium |
| 17.50-18.15 | 203 |
Process Development
of a Highly Purified, Native Factor VIII / von Willebrand Factor
Concentrate. Dj. Josic*1, M. Stadler1, G. Gruber1, Ch. Kannicht2 and H. Schwinn1, 1Octapharma GmbH, Vienna, Austria and 2 Octapharma Laboratory, Berlin, Germany |
| 18.15-18.40 | Coffee Break | |
| 18.40-19.05 | 204 |
A Pharmaceutical
Apotransferrin Product for Iron Binding Therapy Leni von Bonsdorff1, Hannele Tölö1, Enni Lindeberg1, Tuula Nyman2 , Anna Harju3 and Jaakko Parkkinen1 1 Finnish Red Cross Blood Transfusion Service, 2Institute of Biotechnology, and 3Department of Virology, Haartman Institute, University of Helsinki, Helsinki, Finland |
| 19.05-19.30 | 205 |
The Effect of
Cake Collapse on the Stability of Freeze-dried rFVIII J.M. Hey and D.Q. Wang, Bayer Corporation, 800 Dwight Way, Berkeley, CA 94710, USA. |
| 19.30-19.55 | 206 |
Novel method for
preparation of clinically acceptable room temperature stable
intravenous, intramuscular and subcutaneous liquid immunoglubulin
solutions G. Coppola, S. Vyas, V. Gurevich, N. H. Goss and J. Bertolini* Bioplasma Division, CSL Limited, 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia |
| 19.55-20.20 | 207 |
Local Drug Delivery
from Human Fibrin Sealant Julia Tait Lathrop1*, Tammy Chihos1, Zhong Ming Li1, Jasmine Riley1, and David M. Mann2 1Plasma Derivatives Laboratory, The American Red Cross Holland Laboratory, Rockville, MD 20855, 2 Clearant, Inc., Gaithersburg, MD, 20850 |
| 20.20-20.30 | Discussion | |
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Session 3; Clinical Issues Chairman; Darryl Maher |
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| 08.30-09.00 | 301 |
COMPARATIVE IMMUNOGENICITY
OF PLASMA DERIVED AND RECOMBINANT FVIII PRODUCTS IN HAEMOPHILIA
A MICE R. Kotitschke1, M. Behrmann2, M. Kloft1, J. Pasi3, J.M. Saint-Remy4. 1 Biotest Pharma GmbH, Dreieich, D; 2 University of Frankfurt, D; 3 University of Leicester, UK; 4 University of Leuven, B |
| 09.00-09.30 | 302 |
Clinical Uses
of Plasma Derived Tissue Adhesives: William Spotnitz, Temple University, 3rd Floor Parkinson Pavilion, Suite 300, Philadelphia, PA, USA E-mail: spotniwd@tuhs.temple.edu |
| 09.30-10.00 | 303 |
Practical Applications
of Plasma Derived Tissue Adhesives: Sandra Burks, University of Virginia , Tissue Adhesive Center, Charlottesville, Virginia, USA E-mail: sgb2c@virginia.edu |
| 10.00-10.30 | Coffee Break | |
| 10.30-11.00 | 304 |
Clinical experience
with a human surgical sealant (Quixil), a plasma
derivative of human origin, in liver and orthopaedic surgery. Bernadette Hendrickx*, Lode Dewulf, Sue Bhadare, Andy Smith |
| 11.00-11.30 | 305 |
Development of
Therapeutic Use of Plasma Apotransferrin Jaakko Parkkinen*, Leni von Bonsdorff, Sanna Matinaho, Freja Ebeling, Leila Sahlstedt, Eeva Juvonen, Tapani Ruutu, Finnish Red Cross Blood Transfusion Service and Helsinki University Hospital, Finland |
| 11.30-12.00 | 306 |
Renewed Evaluation
of Fibronectin in the Treatment of Chronic Skin Wounds Bernard Horowitz, Ph.D*, Horowitz Consultants, LLC, New Rochelle, NY, USA and André Beaulieu, MD, Dermacor, Inc., Sainte-Foy, QC, Canada, Fax: 914-636-5620 E-mail: horowitzconsult@aol.com |
| 12.00 Lunch | ||
|
Session 4; Regulatory Perspectives Chairman; Albert Farrugia |
||
| 17.00-17.10 | 401 |
The role of regulation
in shaping the plasma products industry in the 21ST century
Chairman´s Introduction Albert Farrugia, Manager, Blood and Tissue Services, Therapeutic Goods Administration, Australian Commonwealth Department of Health. |
| 17.10-17.40 |
402 |
Optimal use of
plasma products - an essential component of the blood safety
paradigm Rainer Seitz, Paul-Ehrlich-Institut, 63225 Langen, Germany FAX +49-6103-771250; E-mail: seira@pei.de |
| 17.40-18.10 | 403 |
Prevention of
infections by blood products: Recent activities of the German
Natl. Advisory Committee "Blood" (Arbeitskreis Blut) Reinhard Burger, Robert Koch-Institute, Berlin |
| 18.10-18.40 | 404 |
Regulatory issues
in the provision of "in-house" autologous fibrin sealant
Rick Tocchetti*, Fibrin Sealant Services, Transfusion Medicine Unit, Division of Haematology Institute of Medical and Veterinary Science, Royal Adelaide Hospital, North Tce SA 5000 Australia |
| 18.40-19.00 | Coffee Break | |
| 19.00-19.30 | 405 |
"Use of international
guidelines for national regulation of plasma products -help or
hindrance?" Rachel Karpel, Director, Institute for Standardization and Control of Pharmaceuticals, Ministry of Health, State of Israel |
| 19.30-20.00 | 406 |
Monitoring the
viral safety of plasma products by nucleic acid amplification
technology Karen Cristiano*, Giulio Pisani, Maria Wirz, Guillermo Bisso, Carlo Pini, Giuliano Gentili Laboratory of Immunology, Istituto Superiore di Sanità, Rome, Italy |
| 20.00-20.30 | 407 |
Regulation and
the Plasma Industry: An Impediment to Innovation or a Stimulus
to Excel ? Thierry Burnouf, PhD, HPPS, 18 Rue Saint-Jacques, 59800 Lille, France |
|
Session 5; Manufacturing Chairman; Johan Vandersande |
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| 08.30-08.55 |
501 |
Implementation
of a State-of-the-Art Zone Concept Ernst Hetzl*, Heinrich Mahler, Peter Neuper, Christian Weiner Baxter Hyland Immuno, Benatzkygasse 2-6, A-1220 Vienna, Austria |
| 08.55-09.20 | 502 |
Innovative Automated
Filling Line With Isolation Technology for Lyophilized Coagulation
Products, Archie Woodworth, Hyland Immuno Division of Baxter Healthcare International |
| 09.20-09.45 | 503 |
Plasma fractionation
using Powerfuge centrifugation technology: A case study. Rudy Vasquez, MedImmune, 550 Research Dr., Frederick, MD 21703, U.S.A. |
| 09.45-10.10 | Coffee Break | |
| 10.10-10.35 | 504 |
Manufacturing
and Characterization of ReFacto, a B-Domain-Deleted Recombinant
Factor VIII Product Helena Sandberg, Plasma Products, Pharmacia, Stockholm, Sweden |
| 10.35-11.00 | 505 |
Evaluation and
development of regeneration conditions for chromatography and
filtration steps Frank van Engelenburg, Jan Over, and Harry Hiemstra, CLB-Amsterdam |
| 11.00-11.25 | 506 |
Design, construction
and validation of a dedicated production facility for the large-scale
production of Human Immune Globulin Intravenous by a highly efficient,
chromatographic purification process. Ron Newcomb, IGIV-Chromatography. Bayer Corporation, Biological Products, Clayton, NC 27520, USA |
| 11.25-11.50 | 507 |
Reconstruction
of a Plasmaprotein Production Plant at Aventis Behring, Marburg Dr. Horst Boeder, Aventis Behring GmbH, P.O. Box 1230, D-35002 Marburg |
| 11.50-12.00 | Discussion | |
| 12.00 Conference Photograph | ||
| 12.30 Lunch | ||
|
Session 6; Safety Considerations Chairman; Bernard Horowitz |
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| 15.00-15.20 |
601 |
Experimental designs
as a basis for robustness studies of viral inactivation methods. Harry Hiemstra 1* and Frank van Engelenburg 2 CLB, Sanquin Blood Supply foundation, Plesmanlaan 125, 1066 CX, Amsterdam, the Netherlands 1 Department of Product and Process Development, e-mail; h_hiemstra@clb.nl & 2 Virus Safety Services |
| 15.20-15.40 | 602 |
Establishing Process
Robustness: Bench-scale Designed Experiments for Process Validation
of Monoclonal Antibody Chromatography Step Used in the Manufacturing
of a Factor IX Product. Nagender Yerram*, James Cavanaugh, Douglas Bigler and Christopher Bryant, Aventis Behring L.L.C, P.O. Box 511, Kankakee, IL 60901, USA |
| 15.40-16.00 | 603 |
Partitioning of
PrPsc in the chromatographic processes of plasma derived proteins. Eric Uren*, Michael Kleinig, Pat Thomas, Neil Goss, CSL Bioplasma, Melbourne, Australia, Fax: +61 3 9246 5469 e-mail:eric_uren@csl.com.au |
| 16.00-16.20 | 604 |
Demonstration
of the partitioning of endogenous human parvovirus B19 (B19)
in the production intermediate samples of chromatographic steps
of plasma derived products and in B19 scale-down studies. David Johnstone, Connie Broumis, Trudi Wentzel, Randel Fang, Neil Goss, Eric Uren*, CSL Bioplasma, Melbourne, Australia, Fax: +61 3 9246 5469 e-mail:eric_uren@csl.com.au |
| 16.20-16.40 | Discussion | |
| 16.40-17.10 | Coffee Break | |
| 17.10-17.30 | 605 |
The Development
of PureBright® Technology as a Virus Inactivation Step for
Plasma Derived Therapeutic Proteins. William H. Cover* and Kent Salisbury. Pathogen Inactivation Research Laboratories; PurePulse Technologies, Inc., San Diego, CA |
| 17.30-17.50 | 606 |
Pathogen Inactivation
of Plasma Derivatives by Broad Spectrum Pulsed Light Thomas F. Busby *, PhD and Hao Xue, MS; Holland Laboratory American Red Cross; Rockville, MD 20855, USA & William H. Cover, PhD; PurePulse Technologies Inc.; San Diego, CA 92123, USA |
| 17.50-18.10 | 607 |
INACTINE(TM) Technology:
Product Applications And Critical Parameters Influencing Pathogen
Inactivation Aris Lazo*; Veronica Gibaja; Douglas Lunderville, Andrei Purmal, Kevin Plunkett; Richard Keys; Wenjie Cheng; Clark Edson; Asa Ohagen and John Chapman. V.I.Technologies, Inc. Watertown, MA 02472 |
| 18.10-18.30 | Discussion and Closing Remarks | |
| Posters | |
| 701 |
New More Efficient
Method of Cryogranulation for Freezing High Density Biopharmaceuticals David Sesin, Integrated Biosystems, 536 Stone Road, Suite H, Benicia, CA 94510, USA, dsesin@integratedbio.com |
| 702 |
HYQ-GRANUSEAL:
AN INNOVATIVE DRY GRANULAR FIBRIN TISSUE ADHESIVE FOR NEW APPLICATIONS
IN WOUND CLOSURE, DRUG DELIVERY AND GENERAL TISSUE ENGINEERING Dr. Armin Prasch*, Dr. Bernhard Luy HyQSovelopment, 79589 Binzen, Germany, info@HyQsolvelopment.com |
| 703 |
Shelf-Life Stability
Study For Immune Globulin Intravenous (Human) S/D, 5% Solution Rajesh Parti.,* Meg Silva., Baxter Healthcare Corporation, Hyland Immuno, 1720 Flower Avenue, Duarte, CA 91010 |
| 704 |
Ultrafiltration:
Method for Removal of Endotoxins from IgG Solutions G. Coppola, S. Vyas, N. H. Goss and J. Bertolini, Bioplasma Division, CSL Limited, 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia |
| 705 |
A chromatographic
method for purification of Intravenous Immunoglobulin. I.Andersson, L. Huebinette and L-O Lindquist. Amersham Pharmacia Biotech, Uppsala, Sweden |
| 706 |
Biological Properties
of a New Solvent-Detergent treated Anti-D Immunoglobulin John More, Bio Products Laboratory, Elstree, Herts, UK, WD6 3BX |
| 707 |
Process safety:
Resin lifetime & monitoring for chromatography processes. Etienne Vandamme*, Baxter Hyland Immuno, Lessines, Belgium. |
| 708 |
THE FIRST IN RUSSIA
EXPERIENCE OF THE USE OF LARGE-SCALE CHROMATOGRAPHY IN PRODUCTION
OF PLASMA PROTEIN PREPARATIONS. Ò.Dereza*, À.Berkovski, Ì.Àjiguirova. National Research Centre for Haematology, Moscow, Russia. |
| 709 |
REGISTRATED PRODUCTS
OF SPECIFIC IMMUNOGLOBULINS OBTAINED FROM PLASMA PHERESIS DONORS
IN YUGOSLAVIA Romic M*., Tomovic O., Plecaš D1., Laloševic D.2, Trkuljic3., Gligorovic V National Blood Transfusion Institute,Belgrade 1Institute of Obs. and Gyneacol, Clinical Center of Serbia, 2Pasteur Institute,Novi Sad, 3Military Medical Academy, Belgrade |
| 710 |
Cleaning and Process
Qualification Studies for Plasma Protein Products with Tangential
Flow Ultrafiltration Pellicon 2 Cassettes Marty Siwak, Ken Dibble, Aline Seilly, Charles Christy, Robert Blanck*, Millipore Corporation, Michael Morey, Keith Schokman, CSL Bioplasma |
| 711 |
Application of
nanofiltration as viral removal step during factor IX concentrate
(AIMAFIX ®D.I.) production process Antonietta Morrica, Sara Mondini, Arianna Petrucci, Andrea Morelli*, Elisa Moretti, Anna Falbo, Claudia Nardini. Kedrion S.p.A., via Provinciale 1, 55027 Bolognana, Gallicano (Lucca), Italy. |
| 712 |
Characteristics
of Benzamidine Sepharose 4 Fast Flow (high sub) J Färenmark, J Gustavsson, I Lagerlund, T Pless, J Sigrell, H Westergren, Amersham Pharmacia Biotech, Sweden |
| 713 |
Assessment of
remaining protein residues after regeneration of the CM-Sepharose
and sanitation of the ultrafiltration system used in the purification
of Immunoglobulins. Anna-Lena Löf*, Ann-Charlotte Hinz, Anders Johansson Michael Löf. Pharmacia AB, Stockholm, Sweden |
| 714 |
New Clinical Indications
and New Deliveries for Old Products. A. Johnston, N. H. Goss, Research and Development, Bioplasma, CSL Limited, 189-209 Camp Road, Broadmeadows, VI 3047. anna_johnston@csl.com.au |
| 715 |
Impact of Platelets
on Plasma Quality as Assessed by Platelet Surrogate Markers and
Factor VIII Recovery. J. Siekmann1, B. Pretterhofer1, A. Weber1, P.L. Turecek1, J. Moriarty2, J. Dieter2, G. Kunas2, K. Earles3, and D. Amrani3. Baxter Healthcare Corp., Hyland Immuno, Vienna, Austri; Fenwal2 and CRTS3, Round Lake, IL USA. |
| 716 |
FACTOR VIII SD-35-15NM:
A NEW SAFETY STANDARD FOR PLASMA-DERIVED FACTOR VIII S. Chtourou*, P. Porte, C. Mazurier, R. Schmitthaeusler, N. Bihoreau, A. Sauger, F. Bridey, Laboratoire Français du Fractionnement et des Biotechnologies, France, 33 1 69 82 73 72 chtourou@lfb.fr |
| 717 |
APPLICATION
OF PCR FOR THE QUALITY CONTROL OF PLASMA FOR FRACTIONATION WITH
RESPECT TO NON ENVELOPED VIRUSES. Aubin J-T1*, Aleman M-H2, Defer C3, Ferré V2, Peyre R4, Barin F4, Billaudel S2, Maniez Montreuil M3, Vidaud M5, Bergeat P1, Flan B1. 1Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis. 2CHU de Nantes. 3EFS Lille. 4CHU de Tours. 5 Faculté Paris V France. |
| 718 |
ADDITION OF A
75 - 35 NM FILTRATION STEP TO THE PH4 - PEPSIN TREATMENT OF IGG
PRODUCTION PROCESS. P. Porte, N. Bihoreau*, C. Groseil, F. Dhainaut, O. Just, C. Potentini, I. Sans, A. Sauger, S. Chtourou.Laboratoire Français du Fractionnement et des Biotechnologies. |
| 719 |
STUDY ON THE SCALE-UP
OF HUMAN IgG3 PURIFICATION USING PROTEIN A AFFINITY CHROMATOGRAPHY J.E.Amaral (1,2)*, M.Inganas (3), J.M.S.Cabral (2), D.M.F.Prazeres 2). (1) Department of Chemical Engineering, Instituto, Superior de Engenharia de Lisboa (ISEL), R.Conselheiro Emídio Navarro, Lisboa, Portugal. (2) Centre for Biological and Chemical Engineering, Instituto Superior Técnico de Lisboa (IST), 1049-001 Lisboa, Portugal. (3) Amersham Pharmacia Biotech, SE-75184 Uppsala, Sweden. |
| 720 |
The Role of Various
Stabilizers in the Acquisition of Thermo- Tolerance in Factor
VIII Activity. T. Zandieh, M. Farhadi*, M. Sharhr-Abadi** and H. Lotfi, From the Iranian Blood Fractionation and Research Company, Tehran, the *Iranian Blood Transfusion Service, Tehran and the **Virology Lab, Rasool Akram Hospital, Tehran, I.R. Iran |
| 721 |
Inactivation
of enveloped and non enveloped viruses in protein solutions with
halogenacetaldehydes. Peder Bergvall*, Tanja Ahmad, Herbert Bauman, Henrik Wadensten, Magnus Towner, Amersham Pharmacia Biotech, Uppsala, Sweden |
|
Isolation
of ATIII from Cohn fraction IV-1: A Comparative Evaluation of
several affinity chromatography supports. Zarzur Jorge*, Bernardi M. Eugenia, Bermudez Cecilia, Oviedo Sergio, Hurvitz Ariela, Moya Cristian, Vitali Susana.. Laboratorio de Hemoderivados. Universidad Nacional de Córdoba (UNC-HEMODERIVADOS) República Argentina. |
|
| 723 |
Methods
for the removal of INACTINE™ compound from human plasma. I.Andersson, S. Eriksson, O. Lind. Amersham Pharmacia Biotech, SE-751 84 Uppsala Sweden. |
| 724 |
APV
& coll. :20 years of Worldwide experience in Fractionation
facility concept, installation & start-up. Petel Damien & Jacques Carme, APV France |