Program

Monday 13 May 2019
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

Tuesday 14 May 2019
Session 1. Manufacturing perspectives
Session chair: Geoffrey Pot, Takeda, Belgium
101 Ethanol-free fractionation of plasma for simultaneous production of IgG and Albumin

Fereidoun Mahboudi, Morteza Jaffaraghaei*, Hesam Tavoli, Forugh Havasi, Amir Hossein Karagah

PersisGen Par, Tehran-Iran

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

103 Sustainability @ Takeda´s Plasma Business

Alexander Eder*, Head of Vienna Site Development

Takeda Vienna / Austria

104 AlbuRx Polishing by a Weak Anion Exchanger

Adrian Alder*, Joel Kuon, Michael Steinmann, Jeannette Erne, Ibrahim El-Menyawi

CSLBehring

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

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

Takeda Lessines Belgium ; Merck

Session 2: Applications of Plasma Products and Clinical Developments
Session chair: Merche Faro, GRIFOLS, Bioscience Industrial Group, Spain
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

202 Treatment of Aceruloplasminemia with fresh frozen plasma transfusion – case report and review of the literature

Rosaria Bonini*1, Alberto Piperno2

1Blood Transfusion Centre, Lucca, Italy ,  2 Internal Medicine Unit, S. Gerardo Hospital, Monza, Italy

203 ClearPlasma™ a novel treatment for massive bleeding

Zeev Dvashi, Nuha Higazi, samah waked, Abd Al-Roof Higazi

PlasFree, Nazareth, Israel

204 Primary Immunodeficiencies: a model how to personalize medicine

P. Martin van Hagen*

Erasmus Medical Center, Rotterdam , The Netherlands

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.

Wednesday 15 May 2019
Session 3: New Products & Innovations in Plasma Processing 
Session chair: Sami Chtourou, LFB Biotechnologies, France
301 Hemopexin: The Potential Therapeutic Role for Treatment of Hemolytic Disease

Nathan Brinkman, CSL Behring, Kankakee, IL

302 Flow Induced Dispersion Analysis (FIDA) for size-based characterization of proteins and aggreagates under native conditions

Morten E. Pedersen1, Sarah I. Gad1, Brian Sørensen1, Jesper Østergaard1,2, and Henrik Jensen1,

1FIDA-Tech Aps, Universitetsparken 2 (C/O University of Copenhagen), 2100 Copenhagen, Denmark,
2Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.

303 New Insights on Inter-alpha Inhibitors: Emergence of Broad Inflammatory Targets

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

304 Comparison of antioxidant properties and posttranslational modifications between various commercial albumins

Filippo Mori* and Claudio Farina

Kedrion, Lucca , Italy

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

Guido Stroehlein1,*, Gerald Platteau1, Jim Van Alstine2, Masayoshi Nagaya3

1JSR Life Sciences, Technologielaan 8, 3001 Leuven, Belgium 2JMVA Biotech, Orvar Odds väg 8, Stockholm, Sweden, 112 54 3JSR Life Sciences, 1280 N. Mathilda Ave., Sunnyvale, CA 94089, USA

306 Use of immune receptor-based affinity purification technology to enable the rapid production of highly potent plasma Immunoglobulin G therapy against emerging viral threats

Austin Boesch1*, Glen Bolton1, Julie Fox2, Michael Diamond2

1. Zepteon, Inc, Boston, MA, United States.
2. Washington University in St. Louis, St. Louis, MO, United States.

Session 4: Quality and Regulatory Trends
Session chair: Albert Farrugia, Kedrion Biopharma, Italy
401 The European Medicines Agency post-Brexit – Implications for biological therapies

Sol Ruiz

Head of Biologics, Biotechnology and Advanced Therapies, Spanish Medicines Agency, chair of the Biologics Working Party (BWP), co-opted Member of the Committee for Medicinal Products for Human Use (CHMP) at EMA

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).

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

404 Managing choices in the era of riches – what do patients with haemophilia REALLY want

Andrea Buzzi*

Fondazione Paracelso, Milan, Italy

405 Innovation in Italian Biotechnology

Davide Rosiello

BIOVIIIx S.r.L.

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
Session 5: Pathogen Safety
Session chair: Albrecht Gröner, PathoGuard Consult, Germany
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

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

erapore Technologies  South San Francisco , CA . USA

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

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

505 Perceived or real risk from prions in plasma-derived medicinal products (PDMPs)

Larisa Cervenakova

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

506 Development Pathways for Advanced Therapy Medicinal Products - Virus Safety Challenges and Regulatory Perspectives

Andy Bailey

ViruSure GmbH, Vienna, Austria

Session 6: Markets, Policies and Strategies
Session chair: John Curling, John Curling Consulting AB, Sweden
601 An Italian model of Plasma and PDMP Self-sufficiency

GC Liumruno, INBC

602 Current situation on the quality and safety of the supply of plasma for manufacturing in Asia

P Strengers, IFPA

603 Global Sufficiency and the Global Donor

J Penrod, PPTA

604 The Changing Economics of Plasma Fractionation

R Cummins, MST

605 An evolutionary tale of the plasma protein industry. What has evolved and what has not.

J Bult, PPTA