Program

Monday 13 May 2019
15:00 - 20:00
Registration and Poster Setup
18:00 - 19:00
Welcome Reception
19:00 - 19:15
Opening Remarks

Joseph Bertolini, Chairperson, Organizing Committee

19:15 - 20:15
Keynote: How to Address Growing Plasma Demand while Retaining the Principles of Voluntary non-Remunerated Donation?

Dr Pieter de Geus, Member Executive Board, Sanquin Blood Supply, The Netherlands

20:30 - 22:30
Opening Dinner
Tuesday 14 May 2019
08:20 - 12:00
Session 1. Manufacturing Perspectives
Session chair: Geoffrey Pot, Takeda, Belgium
08:30 - 09:00
101 Scale-Down-Model (SDM): Advantages and Limitations

Miloš Komenda and Ibrahim El Menyawi*
Research and Development, CSL Behring AG, Berne, Switzerland

09:00 - 09:30
102 Next Generation Technology for the Extraction of Human Plasma Proteins

Fiana Levitin PhD, David Miller BASc, Mark Krause, BSc, MBA; 
Evolve Biologics, Mississauga, Canada

09:30 - 10:00
103 Sustainability @ Takeda´s Plasma Business

Alexander Eder*, Head of Vienna Site Development
Takeda Vienna, Austria

10:00 - 10:30
Coffee break
10:30 - 11:00
104 Safeguarding the Biomanufacturing Supply Chain: Practical Steps to Manage Raw Material and Process Risks in the Plasma Industry

Elles Steensma*, Security of Supply Program Leader, GE Healthcare, Uppsala, Sweden

11:00 - 11:30
105 Interaction Effects of Process Related Non-ionic Surfactants and Solvents on PES and Cellulose Membranes that are commonly Used in Plasma Purification for Virus Filtration, Ultrafiltration and Sterile Filtration process steps

Benjamin Schneider*, Björn Hansmann, Geert Lissens
Sartorius Stedim Biotech GmbH, Göttingen, Germany

11:30 - 12:00
106 From Concept to Reality: Successful use of Single-pass TFF to reach High Protein Concentrations during Commercial Production of Plasma derived Products

Torsten Bisschop and Gert Verheyden
Merck, Vienna, Austria and Takeda, Lessines, Belgium

12:15 - 16:00
Busses depart for Gole Alcantara

Lunch included

16:20 - 19:00
Session 2: Applications of Plasma Products and Clinical Developments
Session chair: Merche Faro, GRIFOLS, Bioscience Industrial Group, Spain
16:30 - 17:00
201 Non-additive Effects on in vitro Thrombin Generation when Combining pdFVIII/VWF with Emicizumab in Hemophilia A Plasma with or without Inhibitors

Maria Isabel Bravo* (1), Aida Raventos (1), Alba Perez (1), Montserrat Costa (1), Todd Willis (2)
(1) Discovery Research, Bioscience Industrial Group, Grifols, Barcelona, Spain
(2) Discovery Research, Bioscience Industrial Group, Grifols, Raleigh NC, United States

17:00 - 17:30
202 Treatment of Aceruloplasminemia with Fresh Frozen Plasma Transfusion – Case Report and Review of the Literature

Rosaria Bonini*(1), Alberto Piperno(2)
(1) Blood Transfusion Centre, Lucca, Italy , (2) Internal Medicine Unit, S. Gerardo Hospital, Monza, Italy

17:30 - 18:00
203 ClearPlasma™ a Novel Treatment for Massive Bleeding

Zeev Dvashi, Nuha Higazi, Samah Waked, Abd Al-Roof Higazi
PlasFree, Nazareth, Israel

18:00 - 18:30
Coffee break
18:30 - 19:00
204 Primary Immunodeficiencies: a Model how to Personalize Medicine

P. Martin van Hagen*
Erasmus Medical Center, Rotterdam , The Netherlands

19:00 - 20:00
Focus Lecture: Next Generation Disruptive Therapies for Haemophilia

Professor John Pasi, Professor of Haemostasis and Thrombosis
Barts and The London School of Medicine and Dentistry, UK.

20:10 - 22:30
Buffet Dinner
Wednesday 15 May 2019
08:20 - 12:00
Session 3: New Products & Innovations in Plasma Processing 
Session chair: Sami Chtourou, LFB Biotechnologies, France
08:30 - 09:00
301 Protein Purification using Novel Chromatographic Affinity Ligands

Achim Schwämmle*1, Anne Chevrel2, Olivier Kittén2, Elisa Innocenti3, Mikkel Nissum3,
and Ricardo Silva4
1 Merck KGaA, Darmstadt, Germany
2 Affilogic, Nantes, France
3 GSK Vaccines S.r.l., Siena, Italy
4 iBET, Oeiras, Portugal

09:00 - 09:30
302 Flow Induced Dispersion Analysis (FIDA) for Size-based Characterization of Proteins and Aggregates under Native Conditions

Morten E. Pedersen (1), Sarah I. Gad (1), Brian Sørensen (1), Jesper Østergaard (1,2), and Henrik Jensen (1)
(1) FIDA-Tech Aps, Universitetsparken 2 (C/O University of Copenhagen), 2100 Copenhagen, Denmark,
(2) Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.

09:30 - 10:00
303 New Insights on Inter-alpha Inhibitors: Emergence of Broad Inflammatory Targets

Yow-Pin Lim*,
ProThera Biologics, Inc., Providence, Rhode Island, USA

10:00 - 10:30
Coffee break
10:30 - 11:00
304 Comparison of Antioxidant Properties and Posttranslational Modifications between Various Commercial Albumins

Filippo Mori* and Claudio Farina
Kedrion, Lucca , Italy

11:00 - 11:30
305 Introducing Modular Chromatography: A Novel, Lattice-Supported, Stackable Chromatography Cassette for Intensified Bioprocessing

Guido Stroehlein (1)*, Gerald Platteau (1), Jim Van Alstine (2), Masayoshi Nagaya (3)
(1) JSR Life Sciences, Technologielaan 8, 3001 Leuven, Belgium
(2) JMVA Biotech, Orvar Odds väg 8, 112 54 Stockholm, Sweden, 
(3) JSR Life Sciences, 1280 N. Mathilda Ave., Sunnyvale, CA 94089, USA

11:30 - 12:00
306 Use of ImmuneReceptor-based Affinity Purification Technology to Enable the Rapid Production of Highly Potent Plasma Immunoglobulin G Therapy against Emerging Viral Threats

Austin Boesch (1)*, Glen Bolton (1), Julie Fox (2), Michael Diamond (2)
(1) Zepteon, Inc, Boston, MA, United States.
(2) Washington University in St. Louis, St. Louis, MO, United States.

15:15 - 16:20
Poster Session
16:20 - 20:00
Session 4: Quality and Regulatory Trends
Session chair: Albert Farrugia, Kedrion Biopharma, Italy
16:30 - 17:00
401 The European Medicines Agency post-Brexit – Implications for biological therapies

Dominika Misztela

Senior Director, Regulatory Policy Europe, Plasma Protein Therapeutics Association

17:00 - 17:30
402 Good Practices and Good Manufacturing Practices – Introduction of Quality Concepts in Blood Component Production in the Italian Transfusion Service.

Pierluigi Berti*
Regional Blood Centre, Aosta Valley, Italy and President, Italian Society of Transfusion Medicine and Immunohematology (SIMTI)

17:30 - 18:00
403 The Evolution of the Plasma Master File – Managing Cross Border Plasma Traffic across and beyond the EU

Karen Cristiano
Biologicals and Biotechnologicals Unit, National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore di Sanità, Rome, Italy

18:00 - 18:30
Coffee break
18:30 - 19:00
404 Managing Choices in the Era of Riches – what do Patients with Haemophilia REALLY Want

Andrea Buzzi*
Fondazione Paracelso, Milan, Italy

19:00 - 19:30
405 Innovation in Italian Biotechnology

Davide Rosiello
BIOVIIIx S.r.L.

19:30 - 20:00
406 The Continuing Saga of Specific Antibody Titre in Polyclonal Therapeutic Immunoglobulin – an Unholy Alliance between Regulators and Industry?

Albert Farrugia
Kedrion S.p.A, Lucca, Italy

Thursday 16 May 2019
08:20 - 09:00
Session 5: Pathogen Safety
Session chair: Albrecht Gröner, PathoGuard Consult, Germany
08:30 - 09:00
501 Valid down scale of production to laboratory scale – a prerequisite for virus reduction factors predictive for finished product

Klaus Schmitt, Albrecht Gröner*

CSL Behring, Marburg, Germany; PathoGuard Consult, Seeheim-Jugenheim, Germany
09:00 - 09:30
502 Self-Assembled Isoporous Nanofilters for High Throughput Viral Clearance Applications in Bioprocessing

Marty Siwak*,  Christopher Crock, Yibei Gu, Jake Maslowski, Jiawei Zhu, Rachel Dorin
Terapore Technologies  South San Francisco , CA . USA

09:30 - 10:00
503 Extending Parvovirus Removal Filter Applications to Large Plasma Molecules

Nigel Jackson*, Daniel Lourenco, Aernout Martens
Pall Europe Ltd, Portsmouth, UK; Pall Europe Ltd, Portsmouth, UK; Pall Netherlands B.V., Medemblik, Netherlands

10:00 - 10:30
Coffee break
10:30 - 11:00
504 Overview of Virus Filtration for Manufacturing Plasma-Derived Products: 30 Years’ History and Advances

Tomoko Hongo-Hirasaki
Bioprocess Division, Asahi Kasei Medical Co., Ltd., Tokyo Japan

11:00 - 11:30
505 Perceived or Real Risk from Prions in Plasma-derived Medicinal Products (PDMPs)

Larisa Cervenakova
Plasma Protein Therapeutics Association (PPTA), Annapolis, Maryland, USA

11:30 - 12:00
506 Development Pathways for Advanced Therapy Medicinal Products - Virus Safety Challenges and Regulatory Perspectives

Andy Bailey
ViruSure GmbH, Vienna, Austria

13:50 - 17:00
Session 6: Markets, Policies and Strategies
Session chair: John Curling, John Curling Consulting AB, Sweden
14:00 - 14:30
601 An Italian Model of Plasma and PDMP Self-sufficiency
Giancarlo Maria Liumbruno
National Blood Centre, Istituto Superiore di Sanità, Rome, Italy
14:30 - 15:00
602 Current Situation on the Quality and Safety of the Supply of Plasma for Manufacturing in Asia
Paul Strengers
International Plasma and Fractionation Association, Amsterdam, The Netherlands
15:00 - 15:30
603 Global Sufficiency and the Global Donor
Joshua Penrod
Plasma Protein Therapeutics Association, Annapolis, MD, USA
15:30 - 16:00
Coffee break
16:00 - 16:30
604 The Changing Economics of Plasma Fractionation

Rosemary Cummins
MST Marquee, Melbourne, Australia

16:30 - 17:00
605 An Evolutionary Tale of the Plasma Protein Industry. What has Evolved and what has not.
Jan M Bult
Plasma Protein Therapeutics Association, Annapolis, MD, USA
17:00 - 17:30
Concluding Remarks

Dr. Joeseph Bertolini
CSL Behring, Broadmeadows, Australia

20:00 - 22:30
Closing Dinner