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The
Sixth Plasma Product Biotechnology Meeting (PPB09) will be held at Insotel Club Punta Prima Menorca, Spain May 11th - 15th, 2009 |
Final Program
Session 1| Session 2 |Session 3 | Session 4 | Session 5 | Session 6Back to Start Page | Poster List
Guidelines for presentations
Final Program to be printed
Updated March 22, 23, 30, 31, April 22, 2009
| Monday May 11, 2009 | |
| 15.00-19.00 | Poster Setup Registration Desk Open |
| 18.00-19.00 | Welcome Reception |
| 19.00-19.10 | Welcome Address; |
| 19.10-19.20 | In Memory of David Hammond; Timothy Hayes, ProMetic BioTherapeutics, Inc., USA "His life and influence on the plasma fractionation industry" |
| 19.20-20.15 | Keynote Lecture; Victor Grifols, CEO, Instituto Grifols, Spain ”Grifols: from the family to the company - Contributions to Hemotherapy” |
| Tuesday May 12, 2009 | |
| Session 1 Manufacturing Johan Vandersande, Baxter Healthcare Corp., U.S.A. |
|
| 08.30 - 08.35 | Chairperson´s Introduction |
| 08.35 - 09.05 | 101 |
| 09.05 - 09.35 | 102 Application of a Novel Affinity Adsorbent for the Capture and Purification of FVIII Compounds Justin McCue, Senior Engineer, Biogen Idec Corporation, 14 Cambridge Center, Cambridge, MA 02142, U.S.A. |
| 09.35 - 10.05 | 103 The Potential for Low Cost Manufacturing of Safe Plasma Products John Curling*1, Christopher Bryant2, Tom Chen2, Timothy Hayes2, Neil Goss3, Andrew Sinclair4, Janice Lim4 and Mahesh Prashad5. 1. Presenting author, John Curling Consulting AB, Sweden and Senior Advisor ProMetic BioTherapeutics, Inc., 2. ProMetic BioTherapeutics, Inc., U.S.A. 3. Further Options Pty Ltd., Australia, 4. BioPharm Services Ltd., UK, 5. Sartorius Stedim Biotech, U.S.A. |
| 10.05 - 10.30 | Coffee Break |
| 10.30 - 11.00 | 104 Recent Developments & Future Directions in the Production of Monoclonal Antibodies Rob Noel PhD, Upfront Chromatography A/S, Copenhagen, Denmark |
| 11.00 - 11.30 | 105 Implementation of a New Syringe Filling Facility with Isolator Technology Herbert Hrbek, Senior Project Manager, Baxter BioScience, Benatzkygasse 2-6, Vienna, Austria Presented by Ernst Hetzl |
| 11.30 - 12.00 | 106 Grifols' Sterile Filling System Sergi Roura, Instituto Grifols, S.A., Parets del Vallès, Barcelona, Spain |
| 12.00 - 12.45 | Lunch |
| 11.45 - 16.45 | Island Tour |
17.15 - 18.00 |
Focus Lecture; Jan Over, Sanquin Plasma Products, The Netherlands ”Impact of Technology Transitions in the Plasma Business” |
| Session 2 New Approaches to Quality Timothy K. Hayes, ProMetic BioTherapeutics, Inc., U.S.A. |
|
| 18.00 - 18.05 | Chairperson´s Introduction |
| 18.05 - 18.35 | 201 |
| 18.35 - 19.05 | 202 Improving Reliability and Efficiency of a Biopharmaceutical Manufacturing Facility: Risk-based Analysis Chor Sing Tan*(1), Tim Hughes(2) and Joe Bertolini(1), (1)CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia (2)CSL Limited, 45 Poplar Road, Parkville, Victoria 3052, Australia |
| 19.05 - 19.30 | Coffee Break |
| 19.30 - 20.00 | 203 Chromatographically purified albumin: a new surprise K McCann* and J Bertolini, CSL Bioplasma, 189-209 Camp Road, Broadmeadows VIC 3047, Australia |
| 20.00 - 20.30 | 204 Product Brand Integrity: A Global Challenge Stephanie Brecht, Baxter Healthcare Corporation, Westlake Village, CA, U.S.A. |
| 20.30 - | Dinner |
| Wednesday May 13, 2009 | |
| Session 3 New Products Juan I.Jorquera , Grifols S.A., Spain |
|
| 08.30 - 08.35 | Chairperson´s Introduction |
| 08.35 - 09.05 | 301 Production of Flebogamma® DIF: A New Double Inactivated and Nanofiltered Liquid IGIV J. Fernández, P. Ristol* and J.I. Jorquera. R&D Area, Instituto Grifols, S.A., Parets del Vallès, Barcelona, Spain |
| 09.05 - 09.35 | 302 Potential for Better Thrombolytic Therapy with Plasmin, a Novel Plasma Product. Valery Novokhatny, Talecris Biotherapeutics, Research Triangle Park, NC , 27709 U.S.A. |
| 09.35 - 10.05 | 303 Purification and Characterization of a New Highly Purified, Double Inactivated, vWF F. Mori*, I. Nardini, P. Rossi, C. Farina and C. Nardini, Kedrion S.p.A., Via Provinciale n°1, 55027 Bolognana, Lucca Italy |
| 10.05- 10.30 | Coffee Break |
| 10.30 - 11.00 | 304 Structure and Character of Recombinant Human Albumin from Saccharomyces cerevisiae Kazuyuki Nakashima*, Tomoko Fuji, Shinichi Shibata, Tetsuro Tanabe, Kumiko Naotsuka, Shinji Akasaki, Hiroshi Okamura, Masahiro Sakaguchi, Yoshinobu Miyatsu and Hiroshi Mizokami, *The Chemo-Sero-Therapeutic Research Institute Kawabe Kyokushi Kikuchi, Kumamoto 869-1298, Japan |
| 11.00 - 11.30 | 305 Designing Next Generation Chromatography Media for Modern High-Throughput Plasma Processes Mats Gruvegard* and Klas Allmér, GE Healthcare, Uppsala, Sweden |
| 11.30 - 12.00 | 306 Management of a Multi-Product Facility Hugh Price, Sr. Director, Product Development, Cangene Corporation, Winnipeg, Manitoba R3T 5Y3, Canada |
| 12.00 - 16.00 | Lunch and free afternoon |
| 13.00 - 15.30 | Optional tour to Binibequer |
16.00 - 17.00 |
Poster Session |
| Top of page | |
17.15 - 18.00 |
Focus Lecture; Jeffrey Ravetch, Rockefeller University, U.S.A. ”Novel roles for IgG glycans” |
| Session 4 Clinical and Medical Developments Darryl Maher, CSL Bioplasma, Australia |
|
| 18.00 - 18.05 | Chairperson´s Introduction |
| 18.05 - 18.35 | 401 Effect of stabilizers on albumin antiodixant capacity S. Baurin, Th. Branckaert, D. Timmerman, R. Laub* Central Department for Fractionation, Red Cross, Brussels, Belgium |
| 18.35 - 19.05 | 402 |
| 19.05 - 19.30 | Coffee Break |
| 19.30 - 20.00 | 403 Recombinant Human Hyaluronidase Facilitates Dispersion of Subcutaneously Administered Gammagard Liquid Enabled Administration of Full Monthly Dose in a Single Site with Improved Bioavailability in Patients with Immunodeficiency Diseases Richard Schiff, Heinz Leibl*, Werner Engl. Baxter BioTherapeutics |
| 20.00 - 20.30 | 404 Plasma-derived Reconstituted High Density Lipoprotein and its Potential Role in Coronary Atherosclerosis Darryl Maher*, Peter Lerch, Joseph Amon and Russell Basser, CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria, Australia |
| 20.30 - | Dinner |
| Thursday May 14, 2009 | |
| Session 5 Pathogen Safety Hannelore Willkommen, Regulatory Affairs & Biological Safety Consultant, Germany |
|
| 08.30 - 08.35 | Chairperson´s Introduction |
| 08.35 - 09.05 | 501 Challenges for Pathogen Testing Micha Nübling, Head, Molecular Virology, Paul-Ehrlich-Institut, Paul-Ehrlich-Str. 51-59, DE-63225 Langen, Germany |
| 09.05 - 09.35 | 502 |
| 09.35 - 10.05 | 503 |
| 10.05 - 10.30 | Coffee Break |
| 10.30 - 11.00 | 504 B19V and Animal Parvoviruses: a Comparison Jens Modrof, Andreas Berting and Thomas R. Kreil Global Pathogen Safety, Baxter BioScience, 1221 Vienna, Austria |
| 11.00 - 11.30 | 505 A Comparison of the Removal of Parvovirus B19 and Model Parvoviruses from Plasma Products by Virus Filtration Shirley Stagg*, Samantha Fernando, Amy Shackell, Peter Roberts and Joan Dalton, BioProducts Laboratory, Elstree, UK. |
| 11.30 - 12.00 | 506 Prion Infectivity Removal from Human Plasma and Plasma Products Using Affinity Ligands L. Gregori (1,5), B. Lambert (1), P.V. Gurgel* (2), J. Lathrop (3), M. Behizad (4), S. Jordan (4), R. Rohwer (1) 1 VA Medical Center, University of Maryland, Baltimore, MD, USA 2 ProMetic Life Sciences, Mont-Royal, Canada 3 Prolias, Rockville, MD, USA 4 ProMetic BioSciences, Cambridge, UK 5 Current affiliation: Food and Drug Aministration, Center for Biological Evaluation and Research, Rockville, MD, USA. |
| 12.00 - 15.00 | Lunch and free afternoon |
| Session 6 Innovations in Plasma Processing Claudia Nardini, Kedrion S.p.A., Italy |
|
| 15.00 - 15.05 | Chairperson´s Introduction |
| 15.05 - 15.35 | 601 Innovative High Throughput Protein Purification in 96-Array Format Dr. Juergen Friedle, Atoll GmbH, Ettishofer Straße 10, D-88250 Weingarten, Germany |
| 15.35 - 16.05 | 602 Proteomics as an important tool for development of a new process for isolation of clotting factor IX from human plasma Feilei Huang*, Xinli Yang*, James Clifton**, Spomenka Kovac***, Douglas C. Hixson*, Djuro Josic*, ***, *Proteomics Core, COBRE Center for Cancer Research Development, Rhode Island Hospital, Providence, Rhode Island, USA, **Department of Molecular Pharmacology, Physiology and Biotechnology, Brown University, Providence, RI, USA, ***J. J. Strossmayer University of Osijek, Department of Chemistry, HR-31000 Osijek, Croatia. |
| 16.05 - 16.35 | 603 Technical transfer of Kedrion fibrin sealant: evaluation of product scale up and consistency between Giving Site and Receiving Site Arianna Petrucci, Kedrion S.p.A., Via Provinciale 1, 55027 Bolognana, Gallicano, Lucca, Italy. |
| 16.35 - 17.00 | Coffee Break |
| 17.00 - 17.30 | 604 A Modified ManufacturingProcess of Alpha-1 Proteinase Inhibitor Leading to Improved Product Purity James Rebbeor1, William Alonso1, Wytold Lebing1, Charles Ndarathi1, Michelle St Peter1, Kevin Koski1, Chad Ennis1, Eric Schnake1, John Hegarty1, Scott Cook2, Chris Dadd3 Presented by Deborat Barnette1 1Talecris Biotherapeutics, Research Triangle Park, NC, USA 2Wyeth Pharmaceuticals, Sanford, NC, USA 3Unaffiliated, Email: James.Rebbeor@talecris.com, Funding: Talecris Biotherapeutics |
| 17.30 - 18.00 | 605 Development of a recombinant polyclonal antibody product Rozrolimupab to replace plasma derived anti-D products Torben P. Frandsen, Symphogen A/S, Elektrovej, Building 375, DK-2800 Lyngby, Denmark tpf@symphogen.com |
| 18.00 - 18.05 | Closing remarks |
| 19.30 - 20.00 | Cocktail |
| 20.00 - | Closing Dinner |
| Poster list (Guidelines for poster presentation will be available shortly) | |
| 701 |
Small scale automated high throughput chromatographic separations in process development, in-process monitoring and validation of biopharmaceutical production Tim Schroeder and Jürgen Friedle, Atoll GmbH, Ettishofer Straße 10, D-88250 Weingarten, Germany |
| 702 |
Separation of fibrinogen precipitate by a multipurpose processor Arianna Petrucci, Kedrion S.p.A., Via Provinciale 1, 55027 Bolognana, Gallicano, Lucca, Italy. Tel. Number: 0039 1969355 Fax number: 0039 0583 1969966, E-mail: a.petrucci@kedrion.com |
| 703 | Optimisation of Ultrafiltration and Diafiltration for bioprocessing Owen Tatford*, Chor Sing Tan and Joseph Bertolini CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia |
| 704 | Chromatographic purification of a protein C/protein S concentrate, from a waste fraction of plasma fractionation Angelini C, Giovacchini P, Lazzarotti A, Menconi M.C., Farina C., Kedrion S.p.A., Via Provinciale n°1, 55027 Bolognana, Lucca Italy. |
| 705 | Introduction of membrane chromatography in the LFB platform purification process of monoclonal antibodies. Jacky Lirochon, Michel Poulle, Frédéric Dhainaut, Annick Sauger, Monique Ollivier* LFB - Biotechnologies, 3 avenue des Tropiques, BP 305 - Les Ulis, 91958 Courtaboeuf (FRANCE) |
| 706 | Study of the anion exchange chromatographic step operating conditions of the new IgG manufacturing process - Characterisation by Design of Experiment P. Paolantonacci*, D. Gachelin, S. Nakache, A. Poncin, A. Sauger, M. Ollivier LFB Biotechnologies, Les Ulis, France |
| 707 | Biopharmaceuticals and Products for Therapy and Diagnosing of Blood Disorders Developed at Institute of Highly Pure
Biopreparations Valeriy P. Dobritsa*, MD, Prof., IHPB, Saint-Petersburg |
| 708 | Separation and proteomic analysis of therapeutic proteins from human plasma after chromatographic fractionation by a new developed, high capacity anion-exchange resin Egbert Mueller*, Feilei Huang**, Spomenka Kovac***, Xinli Yang**, Djuro Josic**, *** *Tosoh Bioscience GmbH, Zettachring 6, 70567 Stuttgart, Germany, **Proteomics Core, COBRE Center for Cancer Research Development, Rhode Island Hospital, Providence, Rhode Island, USA, ***J. J. Strossmayer University of Osijek, Department of Chemistry, HR-31000 Osijek, Croatia. |
| 709 | Human Alpha-1 Proteinase Inhibitor (TAL6004) Manufacturing Process and Pathogen Safety Nathan J Roth*, Greg Buczynski, Kang Cai, Wendy P Osheroff, & JoAnn Hotta, Pathogen Safety, Talecris Biotherapeutics, Research Triangle Park, NC, USA |
| 710 | Does the Anticomplementary Activity characterize the quality of IVIG preparations ? A. Buchacher*, P. Schluga, J. Müllner and J. Weinberger, Octapharma Pharmazeutika ProduktionsGmbH, Vienna, Austria |
| 711 | Viral safety of specific i.m. immunoglobulins; is it cold-ethanol fractionation and heat treatment at 45°C sufficient for viral inactivation? B. Gebauer*, A. Tre čec, M. imić, D. Hećimović Department of Plasma Fractionation, Institute of Immunology, Zagreb, Croatia, e-mail: bgebauer@imz.hr, atrescec@imz.hr |
| 712 | Analysis of Aggregates in IgG Products Using GEMMA Owen Tatford(1), Phillip Tan(2) and Joseph Bertolini(1) (1)CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia & (2)TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126 USA |
| 713 | Structural characterization of plasma-derived coagulation factor ix using mass spectrometry. CHEVREUX Guillaume, TILLY Nolwenn, FAID Valegh, RAMON Christine, GROSEIL Catherine, RIANDE Sandrine, ANDRE Magali, SCOHYERS Jean-Marc, BIHOREAU Nicolas, SIRET Laurent Laboratoire du Fractionnement et des Biotechnologies (LFB) Unité de caractérisation structurale et d'analyse protéomique 3, avenue des Tropiques, Les Ulis BP 305, 91958 COURTABOEUF |
| 714 | Biochemical Characterization and Virus Reduction of a Novel Human Plasma- Derived 20 Percent Liquid Subcutaneously Administrable Immunoglobulin Preparation Wolfgang Teschner*, Harald Arno Butterweck, Gerhard Pölsler, Thomas R. Kreil, Alfred Weber, Hartmut J. Ehrlich and Hans-Peter Schwarz, Baxter Innovations GmbH, Industriestr. 131, A- 1220 Wien, Austria |
| 715 | Protein stability issues during bioprocessing Peter Asimakis1, Joseph Bertolini2, Owen Tatford2 and Dave E. Dunstan1 1Department of Chemical and Biomolecular Engineering, The University of Melbourne, Victoria 3010, Australia, 2CSL Bioplasma, 189-209 Camp Road, Broadmeadows, Victoria 3047, Australia |
| 716 | The S/D method of Factor VIII virus inactivation using directly in chromatographic procedure 1Georgii L. Volkov*, 1Olena S. Gavryliuk, 3Oleksiy N. Savchuk, 4Sergiy P. Gavrylyuk, 3Ievgeniia N. Krasnobryzha, 1Tseren Purev, 2Turbat Demchigsuren 1Mongol Sciences Institutes, 2Plasomics LLC, 3Shijir International Co. Ltd, Boroo Valley, Mongolia, 4Taras Shevchenko Kyiv National University, Ukraine. georgii.volkov@shijir.mn |
| 717 | Robustness Evaluation of the Nanofiltration Step of the IgG Manufacturing Process on PPV Removal: Effect of Pressure P.Paolantonacci*, J.Kermarrec, C.Goussen, S.Berend, C.Kimmel-Jehan, J.Lirochon, M.Ollivier and B.Flan LFB Biotechnology, Les Ulis, France |
| 718 | Viral safety evaluation of chromatography sanitisation by carry-over study P.Paolantonacci*, S.Boyer, S.Berend, C.Kimmel-Jehan, C.Chenou, B.Flan, M.Ollivier LFB Biotechnology, Les Ulis, France |
| 719 | Capto Blue and Capto Blue (high sub), two new adsorbents for binding of albumin Jenny Lundberg*, Anna Stjerndorff, Åsa Lundström and Johan Färenmark, GE Healthcare, Bjorkgatan, Uppsala, Sweden |
| 720 | VIIISelect affinity purification of recombinant factor VIII Jenny Lundberg, Hanna Wlad, Henrik Neu and Johan Färenmark, GE Healthcare, Bjorkgatan, Uppsala, Sweden |
| 721 | Characterization of a new affinity chromatography resin for purification of human IgG Klas Allmér*, Johan Färenmark, Stefan D Eriksson, Elin Rann Wobbeking, Faramarz Alamravesh and Patrik Adielsson, GE Healthcare, Bjorkgatan, Uppsala, Sweden |
| 722 | Development of CaptoTM Heparin media for purification of MonoFIX®-VF a plasma derived factor IX. Duy Nguyen*, Hung Pham and Darryl Maher, CSL Bioplasma, 189 Camp Rd, Broadmeadows, Victoria 3047, Australia and Klas Allmér*, Björn Garpefjord, Linus Laurin, Ulrika Meyer and Johan Norén, GE Healthcare Bio-Sciences AB, Björkgatan 30, SE-751 84 Uppsala, Sweden |
| 723 | A Comparability Study following ICH Q5E Guidelines for a Change in Virus Filter used to Manufacture a New IVIG John More*, Tara Dolan, Martyn Paddick BPL, Dagger Lane, Elstree, Herts, WD6 3BX, UK |
| 724 | Assist Software and PreDictor plates: De-bottlenecking of the HTPD workflow Carina Engstrand, GE Healthcare Bio-Sciences AB, Bjorkgatan 30, SE-751 84 Uppsala, Sweden Presented by Anna Mjärdestam |
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