| Tuesday May 08, 2007 |
| 15.00 – 19.00 |
Registration Desk Open (Sala Elba, 2nd floor Hermitage Hotel)
Poster Setup (Sala Elena, Congress Center) |
| 18.00 – 19.00 |
Welcome Reception (Roof terrace of Hermitage Hotel) |
| 19.00 – 20.15 |
Keynote Lecture; (Sala Maria Luisa, Congress Center)
"Plasma Protein Products and Biotechnology: Facts and Ideas for New Issues and Developments"Dr. Paolo Marcucci, President and CEO of Kedrion, Italy |
| 20.15 – |
Dinner (Fuoco di Bosco) |
| Wednesday May 09, 2007 |
Session 1 Manufacturing (Sala Maria Luisa, Congress Center)
Chair: Johan Vandersande/Po-Shing Wah, Baxter Healthcare Corp., USA |
| 08.30 - 08.35 |
Introduction
Po-Shing Wah, Baxter Healthcare Corp., Belgium |
| 08.35 – 09.05 |
101
Design, Commissioning and Start-up of a State-of-the-art Fractionation Facility.
Bernard Desmet, Technical Director Engineering, Baxter Bioscience, 4501 Colorado Boulevard, Los Angeles, CA, 90039, USA |
| 09.05 - 09.35 |
102
Set Up of an Ion Exchange Chromatographic Method for the Large Scale Purification of FVIII/vWF Concentrates
Claudio Farina*, Filippo Mori, Ilaria Nardini, Paola Rossi, Claudia Nardini Kedrion S.p.A., via G.Pascoli, 21, 55020 Castelvecchio Pascoli, Lucca Italy |
| 09.35 - 10.05 |
103
The Australian Fractionation Experience
John Lontos, Fractionation Manager CSL Bioplasma,
189-209 Camp Road, Broadmeadows, Victoria 3047 Australia |
| 10.05 - 10.30 |
Coffee break |
| 10.30 - 11.00 |
104
New Facility Design- Flex for Multiple Products
William Bees*, Allan Faurschau and David Kukelko,
Cangene Corp, Winnipeg, Manitoba, Canada |
| 11.00 - 11.30 |
105
High Performance Virus Filtration: Scale-Up and Manufacture of a new 20nm filtered Intravenous Immunoglobulin
John More*, Mark Bulmer, Tara Dolan, Shirley Stagg and Peter Roberts,
BioProducts Laboratory, Elstree, UK. |
| 11.30 - 12.00 |
106
GMP upgrade of a Fractionation plant leads to reduced energy usage.
Giuseppe Piergiovanni, Baxter Bioscience, via della chimica 5, Rieti, Italy |
| 12.00 – 12.45 |
Cold Buffet (Fuoco di Bosco) |
| 12.45 – 16.45 |
Isola d’Elba Tour. Bus leaves from parking lot. |
17.15 - 18.00 |
Focus Lecture
“FDA’s Pharmaceutical Quality Initiatives: Opportunities and Challenges in the Plasma Fractionation Industry”
Andrew C. Chang, Ph.D., Senior Director, PharmaNet Development Group |
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Session 2 New Approaches to Quality (Sala Maria Luisa, Congress Center)
Chair: Timothy Hayes, ProMetic BioTherapeutics, USA |
| 18.00 - 18.05 |
Introduction
Timothy Hayes, ProMetic BioTherapeutics, USA |
| 18.05 - 18.35 |
201
Case study: PAT implementation strategy and Design Space definition for biopharmaceutical downstream processing based on process understanding
Gunnar Malmquist*, Günter Jagschies, Karol Lacki, Hans J. Johansson GE Healthcare Bio-Sciences AB, SE-751 84 Uppsala, Sweden
|
| 18.35 - 19.05 |
202
Process Analytical Technologies for Plasma-Derived Therapeutic Proteins
Pete Vandeberg, Ph.D.
Talecris Biotherapeutics Inc., Clayton, NC USA. |
| 19.05 - 19.30 |
Coffe Break |
| 19.30 - 20.00 |
203
Variability and Comparability of alpha-1-Antitrypsin concentrates: Implications for
Diagnosis and Therapy
Robin Carrell*, Maurice Owen, and Peter Elliott
University of Cambridge, UK, and Canterbury Scientific Ltd, Christchurch, New Zealand. |
| 20.00 - 20.30 |
204
Molecular Characterization of alpha1-Proteinase Inhibitor (A1PI) Present in Products Approved for Augmentation Therapy
P.L. Turecek1), D. Kolarich2), A. Weber1*), A. Mitterer1), M. Graninger1), F. Altmann1), H.P. Matthiessen1), T. Nicolaes3), and H.P. Schwarz1) 1)Baxter BioScience, Vienna, Austria, 2)University of Natural Resources and Applied Life Sciences, Vienna, Austria and 3)University of Maastricht, Netherlands. |
| 20.30 - |
Dinner (Hermitage Restaurant) |
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Thursday May 10, 2007 |
Session 3 Pathogen Safety Issues (Sala Maria Luisa, Congress Center)
Chair: Hannelore Willkommen, NewLab BioQuality AG, Germany |
| 08.30 - 08.35 |
Introduction
Hannelore Willkommen, NewLab BioQuality AG, Germany |
| 08.35 - 09.05 |
301
Progress in the Development of Rapid Blood Screening Tests for Prion
Alex J. Raeber, Ph.D., Director of Research, Prionics AG |
| 09.05 - 09.35 |
302
Analysis of PRDT Affinity Ligand Binding of Disease- Associated Prion Protein and Plasma Proteins from Plasma, Whole Blood, and Plasma Derivatives
Julia Tait Lathrop*1, Luisa Gregori2, Melanie Poncheri1, Brian Lambert2, and Patrick V. Gurgel3
1 American Red Cross R&D, Rockville, MD, 20855 USA
2 University of Maryland, Baltimore, MD 21201 USA
3 Prometic Life Sciences, Montreal, H4P 2L7 CA |
| 09.35 - 10.05 |
303
Viral risk assessment of plasma products, development of a probabilistic model
M.P. Janssen*, J. Over#, H.T.M. Cuijpers#, C.L. van der Poel#, Th. Evers$, and B.A. van Hout*
*Julius Center, University Medical Center Utrecht, The Netherlands
# Sanquin Blood Supply Foundation, Amsterdam, The Netherlands
$ International Plasma Fractionation Association, Amsterdam, The Netherlands |
| 10.05 - 10.30 |
Coffee Break |
| 10.30 - 11.00 |
304
UV-C as an alternative viral inactivation step in the bioplasma industry
David Eakins*; Todd Nikolof; Michelle Burns; Connie Broumis; Randel Fang; Joseph Bertolini; Darryl Maher,
CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia |
| 11.00 - 11.30 |
305
Double Dye: A Method for Reducing Infectivity of Whole Blood
William Owens*(1), Thomas Cesario(1) and Edward Shanbrom(2), University of California, Irvine, (1)Orange, CA and (2)Santa Ana, CA, USA |
| 11.30 - 12.00 |
306
The consideration of the model virus as WNV in virus removal filter
Terry Sato*, Kouichro Yanagida,
Adress: Asahi kasei Medical Co., Ltd. 9-1 Kanda Mitoshiro-cho, Chiyoda-ku Tokyo Japan |
| 12.00 – 13.00 |
Lunch (Fuoco di Bosco) |
| 13.00 – 16.00 |
Afternoon free |
16.00 - 17.30 |
Poster Session (Sala Elena, Congress Center) |
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Session 4 Clinical Studies (Sala Maria Luisa, Congress Center)
Chair: Darryl Maher, CSL Limited, Australia |
| 17.30 - 17.55 |
401
Human Albumin: Is it safe and what is its role?
Darryl Maher*, Fiona Wilson and Joseph Bertolini, CSL Bioplasma, 189 - 209 Camp Road, Broadmeadows, Victoria 3047, Australia |
| 17.55 - 18.20 |
402
Substitution Therapy of a Dilutional Coagulopathy and Organ Trauma by Coagulation Factor Concentrates
G. Dickneite, CSL Behring GmbH, Pharmacology/Toxicology, Emil von Behring-Straße 76, 35041 Marburg |
| 18.20 - 18.45 |
403
Pharmacokinetics, Efficacy and Safety of Human Hepatitis B Immunoglobulin for Intravenous and Intramuscular Use in Prophylaxis of Hepatitis B After Liver Transplantation.
P.Burra#, P.Andreone§, R.Volpes$, D.Canova#, C.Cursaro§, A.Riili§, B.Fiorentino°*, M.Bacci°, S.Guazzini° and A.Marzano°°.
#Azienda Ospedaliera, Padova; §Azienda Ospedaliera S.Orsola Malpighi, Bologna; $ ISMETT, Palermo; °Kedrion S.p.A. °° UODU Gastroepatologia, A.O. San Giovanni Battista, Torino. |
| 18.45 - 19.15 |
Coffee break |
| 19.15 - 19.40 |
404
Plasma Derived Inter-Alpha Inhibitor Complex Proteins: A Novel Immunomodulator in Systemic Inflammation & Sepsis
Y.-P. Lim*, L. Zhang, E. Siryaporn, S.M.Opal, J.F. Padbury, D. Josic, D.C. Hixson.
ProThera Biologics, 551 Warren Ave, East Providence, RI 02914, USA and Rhode Island Hospital/Brown Medical School, Providence, RI, USA. |
| 19.40 - 20.05 |
405
European Guideline for Virus Safety Evaluation of Clinical Trial Material
Hannelore Willkommen, NewLab Bioquality AG, Germany |
| 20.05 - 20.30 |
406
Usage trends of Fresh Frozen Plasma and Human Serum Albumin in Croatia
B. Gebauer *, A. Trescec, D. Hecimovic, B. Golubic Institute of Immunology Rockefeller str. 2 10 000 Zagreb Croatia |
| 20.30 - |
Dinner (Hermitage Restaurant) |
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Friday May 11, 2007 |
Session 5 Innovations in Plasma (Sala Maria Luisa, Congress Center)
Chair: Claudia Nardini, Kedrion SpA, Italy |
| 08.30 - 08.35 |
Introduction
Claudia Nardini,Kedrion SpA, Italy |
| 08.35 - 09.05 |
501
A Novel Method to Separate Blood Proteins with Improved Yields and Activity
William Owens*(1), Thomas Cesario(1) and Edward Shanbrom(2), University of California, Irvine, (1)Orange, CA and (2)Santa Ana, CA, USA |
| 09.05 - 09.35 |
502
Use of fluidised bed chromatography in plasma fractionation
McCann KB*, Wu J, Gomme PT and Bertolini J
CSL Bioplasma, 189-209 Camp Road, Broadmeadows VIC 3047, Australia |
| 09.35 - 10.05 |
503
Second Generation Expanded Bed Adsorption (EBA) Technology For The High Throughput Processing of Cohn Fraction Intermediates
Rob Noel1 and Andrea Morelli2,
1Upfront Chromatography a/s,
Lerso Parkalle 42, Copenhagen DK-2100, Denmark, 2Kedrion S.p.A., Via Provinciale 1, 55027 Bolognana, Gallicano, Lucca, Italy. |
| 10.05 - 10.30 |
Coffee break |
| 10.30 - 11.00 |
504
Direct capture of immunoglobulin G from plasma: a method suitable for hyperimmune globulin production.
Davida Blackman*, Christopher Bryant, Tom Chen, John Curling*, Timothy Hayes, Dale Schmidt, ProMetic BioTherapeutics, Inc., Rockville, Maryland, USA. *John Curling Consulting AB, Uppsala, Sweden. |
| 11.00 - 11.30 |
505
Preparation of human haptoglobin from Cohn fraction V precipitate
Peter Kumpalume, Joan Dalton*, Richard Chester, Adrian Podmore.
R&D, Bio Products Laboratory, Dagger Lane, Elstree, Herts, WD6 3BX, UK. |
| 11.30 - 12.00 |
506
Evaluation of a Chromatographic Manufacturing Step for IgG
Hugh Price*1, Ognjen Grujic1, Jeff Morier1, Andrew Griffiths1, Rob Noel2 1Cangene Corporation, Winnipeg, Canada 2Upfront Chromatography, Copenhagen, Denmark |
| 12.00 – 15.00 |
Lunch (Fuoco di Bosco) and free afternoon |
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Session 6 Recombinant Plasma Proteins(Sala Maria Luisa, Congress Center)
Chair: Joseph Bertolini, CSL Limited, Australia |
| 15.00 - 15.05 |
Introduction
Joseph Bertolini, CSL Limited, Australia |
| 15.05 - 15.35 |
601
CGE-on-the-chip, GEMMA and MALDI TOF mass spectrometry: tools for quality-control of plasma-derived and recombinant (glyco)proteins beyond molecular weight 250 kDa
R. Müller (1), J. Hirschmann (1), M. Kratzmeier (2), H. Elgass (2), C. Laschober (1,2) M. Marchetti (1), W. Szymanski (3) and G. Allmaier* (1)
(1) Institute of Chemical Technologies and Analytics, Vienna University of Technology, Vienna, Austria
(2) Agilent Technologies, Waldbronn, Germany
(3) Institute of Experimental Physics, University of Vienna, Vienna, Austria |
| 15.35 - 16.05 |
602
Mechanisms of action of immunoglobulins : What do they teach us to overcome the shortage of IVIg
Srini V Kaveri,
INSERM UMRS 872,
Centre de Recherche des Cordeliers,
15, Rue de l'Ecole de Médecine,
75006 PARIS,
FRANCE |
| 16.05 - 16.35 |
603
Development of Biopharmaceuticals Based on Recombinant and Natural Proteins in Institute of Highly Pure Biopreparation (HPB).
Valeriy DOBRITSA, M.D.,Ph.D.,Professor,Director, Institute of Highly Pure Biopreparation, 7,Pudozhskaya Str, 197110,Saint Petersburg, Russia |
| 16.35 - 17.00 |
Coffee break |
| 17.00 - 17.30 |
604
Affinity chromatography media for plasma products and recombinant plasma proteins.
L.N. Sierkstra, BAC BV, Huizerstraatweg 28, 1411 GP Naarden, The Netherlands |
| 17.30 - 18.00 |
605
In silico prediction of FVIII epitopes recognized by natural autoantibodies in large plasma pools intermediate fractions and intravenous immunoglobulins (IVIG)
Mario Di Giambattista, Theo Branckaert and Ruth Laub*, Research & Development Unit, Central Department for Fractionation, Red Cross, Brussels, Belgium |
| 18.00 - 18.05 |
Closing remarks |
| 19.30 - |
Closing Dinner (Maitu Restaurant) |
|
701
|
A Unique Method for the Removal of Infectious Agents from Plasma or Serum
Thomas Cesario*(1), William Owens(1) and Edward Shanbrom(2), University of California, Irvine, (1)Orange, CA and (2)Santa Ana, CA, USA |
702
|
IgG purification by different technological approaches
Arianna Petrucci*, Alessia Satti, Elena Giovannini, Sabrina Esposito, Pierangelo Giovacchini, Alessandra Lazzarotti, Andrea Morelli, Claudio Farina and Claudia Nardini.
Kedrion S.p.A., Via Provinciale 1, 55027 Bolognana, Gallicano, Lucca, Italy. |
| 703 |
Non-invasive Characterization of Protein Adsorption on Chromatographic Resins
Egbert Müller, Technical Director, Tosoh Bioscience GmbH, Im Erlich 10, Stuttgart, Germany |
| 704 |
Development of a USP Chapter on Human Plasma
Jean F. Huxsoll, Ph.D., Norvartis Corporation, Emeryville, CA, USA; Timothy K. Hayes, Ph.D.*, Prometic Biotherapeutics, Gaithersburg, MD, USA*; Anita Y. Szajek, Ph.D., United States Pharmacopoeia, Rockville, MD, USA and the members of USP Human Plasma Advisory Panel |
| 705 |
A novel multimodal anion exchange chromatography resin for purification of IgG
Anna Gronberg* Sr. Research Engineer,
Inger Andersson Sr. Research Engineer and
Anders Ljunglof Scientist,
GE Healthcare Bio-Sciences AB, Bjorkgatan 30,
751 84 Uppsala,
Sweden |
| 706 |
Authenticity of virus infection test results using immunoenzyme analysis
Prof. Karyakin AV,
Head of Department of the Government Quality Control and Study of Resources of Transfusion-Infusion Therapy, Scientific Hematology Center, Russian Academy of Medical Science, Moscow, Russia. |
| 707 |
Proteomic investigation of some plasma-derived therapeutic proteins: How important is the quality control of starting materials?
Djuro Josic, Proteomic Core, COBRE Center for Cancer Research Development, Rhode Island Hospital and Brown University, Providence, RI, 02904 USA. |
| 708 |
Improving analytical testing of Intravenous Immunoglobulin (IVIG) products
Owen Tatford*, Vladimir Gurevich, Ying Ha and Joseph Bertolini CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria, Australia 3047 |
| 709 |
Expanded Bed Adsorption: a future alternative to the Cohn fractionation process?
Allan Lihme1*, Marie Bendix Hansen1, Inga Vaarst Andersen1, Thierry Burnouf2
1UpFront Chromatography A/S, Copenhagen, Denmark
2 Human Plasma Product Services, Lille, France |
| 710 |
A new high yielding process for the manufacture of AAT
Peter Kumpalume, Adrian Podmore, Joan Dalton*,Christopher LePage, Bio Products Laboratory, Dagger Lane, Elstree, Herts, WD6 3BX. |
| 711 |
High throughput process development: Determination of dynamic binding capacity
K. M. Lacki*, A. Grönberg, T. Bergander, G. Jagschies GE Healthcare Bio-Sciences AB, Uppsala, Sweden |
| 712 |
Multimodal media libraries for new and old separation challenges
Jean-Luc Maloisel* and Bo-Lennart Johansson; GE Healthcare,
Bio-Sciences AB, SE-751 84 Uppsala Sweden |
| 713 |
Aggregation of protein therapeutics: Is it amyloid formation?
Peter Asimakis 1, Paul Hamilton-Brown 1, Joseph Bertolini 2*, David E Dunstan 1,
1 Department of Chemical and Biomolecular Engineering, University of Melbourne, Parkville, Australia,2 R&D, CSL Bioplasma, Broadmeadows, Australia |
| 714 |
Viral safety of C1-inhibitor NF.
Koenderman AHL1*, Terpstra FG2, Kleijn M1, Over J1, van Engelenburg FA2,
Schuitemaker H2, Van't Wout AB2.
1 Department of Product Development, Sanquin Plasma Products, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands
2 Sanquin Research and Landsteiner Laboratory of the Academic Medical Center of the University of Amsterdam, The Netherlands |
| 715 |
Reduction of irreversible melting and disintegration of the Factor VIII
during virus inactivation by solvent - detergent method
Georgii L. Volkov, Olena S. Havryliuk, Oleksiy N. Savchuk, Sergiy P. Havryliuk, Tseren Purev, Mongol Life Sciences Institutes, Shijir International Co. Ltd,
Booro Valley, Ulaanbaatar, Mongolia, georgii.volkov@mail.ru |
| 716 |
Comparison of plasma derived and recombinant FIX products for prophylaxis and acute treatment of factor IX deficiency
U. Kronthaler*, G. Dickneite; CSL Behring GmbH, Pharmacology/Toxicology, Emil von Behring-Straße 76, 35041 Marburg, Germany |
| 717 |
Interaction of PRDT affinity resin with human serum albumin solutions: binding and removal of disease-specific prion protein
Julia Tait Lathrop1, Patrick V. Gurgel2, Melanie Poncheri1, Brian C. Lambert3 and Luisa Gregori*3
1 American Red Cross R&D, Rockville, MD, 20855 USA
2 Prometic Life Sciences, Montreal, H4P 2L7 CA
3 University of Maryland, Baltimore, MD 21201 USA |
| 718 |
Application of Capto Q for Purification of Immunoglobulin G.
Maria A. Azhigirova, Tatiana L. Dereza*, Oksana G. Kuturova, The National Research Centre for Haematology, Moscow, Russia |
| 719 |
CaptureSelect Ligands; A Novel Purification Platform
Ingeborg Gemeren, BAC BV, Huizerstraatweg 28, NL-1411 GP Naarden, the Netherlands |
| 720 |
Process Optimization of an Anionic-Exchange-Chromatography Method for Large Scale Immunoglobulin Purification
V. Förtsch *, S. Gilgen, I. Stempfel, P. Kipfer, J. Berger, A. Nigsch, CSL Behring, Bern Switzerland |
| 721 |
Influence of construction on the functionality of a chromatography column
V.Förtsch, A.Nigsch, W.Läderach, R.Kraus, M.Rentsch*, CSL Behring, Berne Switzerland |
| 722 |
Characterization of a New IgG Binding Adsorbent
Patrik Adielsson*, Hanna Wlad, Stefan Eriksson, Faramarz Alamravesh, and Johan Färenmark
GE Healthcare Bio-Sciences AB, SE-751 84 Uppsala Sweden |
| 723 |
Characterization of a New Albumin Binder Adsorbent
Johan Färenmark*, Anna Stjerndorff, Anna Mattson, Åsa Lundström, Jenny Lundberg
GE Healthcare Bio-Sciences AB, SE-751 84 Uppsala Sweden |
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