Updated June 28, 2001

Final Programme
Plasma Product Biotechnology Meeting 2001
May 14th - 17th

 

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Session 1| Session 2 |Session 3 | Session 4 | Session 5 | Session 6 | Posters

Monday, May 14th, 2001, 19.15 - 20.00

19.15-20.00

“Past, present and future directions in plasma protein biotechnology”  

Professor Juhani Leikola, Finnish Red Cross Blood Transfusion Service,. Finland

Tuesday, May 15th, 2001, 08.30 - 12.00

Session 1; Research and novel technologies
Chairman; Jan Over
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 

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Tuesday, May 15th, 2001, 17.00 - 20.30

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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Wednesday, May 16th, 2001, 08.30 - 12.00

Session 3; Clinical Issues
Chairman; Darryl Maher
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

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Wednesday, May 16th, 2001, 17.00 - 20.30

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

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Thursday, May 17th, 2001, 08.30 - 12.00

Session 5; Manufacturing
Chairman; Johan Vandersande
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

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Thursday, May 17th, 2001, 15.00 - 18.30

Session 6; Safety Considerations
Chairman; Bernard Horowitz
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

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Tuesday - Thursday

 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

 722

 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

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