The Fifth
Plasma Product Biotechnology Meeting (PPB07)
will be held at Hotel Hermitage-Biodola
Elba, Italy
May 8th - 12th, 2007

Final Program
being printed

Session 1| Session 2 |Session 3 | Session 4 | Session 5 | Session 6 | Poster List
Presentation guidelines

Updated June 11, 2007

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

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)
Timothy Hayes, ProMetic BioTherapeutics, USA

18.00 - 18.05 Introduction
Timothy Hayes, ProMetic BioTherapeutics, USA
18.05 - 18.35

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)
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)
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)
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)
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)

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Poster list

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
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

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,

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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