Programme

Monday 15 May 2017
15:00 - 20:00
Registration
19:15 - 20:00
Opening Remarks & Keynote Lecture

"The Vitality of the Plasma Therapeutics Industry"

Keynote Lecturer: John Perkins, CEO, BPL Holdings, United Kingdom
Tuesday 16 May 2017
Session 1 Manufacturing Perspectives
Chair: Geoffrey Pot, Shire, Belgium
08:30 - 09:00
101 Impact of Filter Membrane Orientation on Depth Filter Performance During Commercial Production of Plasma Derived Products: A Case Study

Gert Verheyden et al, Shire, Lessines, Belgium

09:00 - 09:30
102 Optimizing Automated Buffer Management in Plasma Fractionation

Joakim Lundkvist et al, GE Healthcare, Uppsala, Sweden

09:30 - 10:00
103 Improving the Purity of Plasma Proteins

Steve Burton et al, Prometic Bioseparations Ltd.

10:00 - 10:30
Coffee break
10:30 - 11:00
104 Affinity Chromatography, a Robust Technology for the Purification of a rhFVIIa Coagulation Factor

Damien Bataille et al, LFB Biotechnologies, Les Ulis, France

11:00 - 11:30
105 Analytical Refractometry for Protein Determination: Evaluation of Manual and Automated Instruments and Procedures for Process Analytical and Quality Control Application

Heinz Anderle, Alfred Weber*, Karin Herbinger, and Stefan Zlabinger

Shire, Vienna, Austria
11:30 - 12:00
106 High Viscosity Tangential Flow Filtration (TFF) Applications in IgG

Craig Jackson* et al, Merck Life Science, Bedord, MA, USA

12:15 - 16:00
Lunch break and Valletta tour
16:25 - 19:00
Session 2 Quality and Regulatory Affairs
Chair: Albert Farrugia, Kedrion Biopharma, Italy
16:30 - 17:00
201 The German Experience in Policy Evolution for Haemophilia Therapies – From IQWIG to AMNOG to ACCESS

Uwe Schlenkrich, Publisher Haemophilia News, Leipzig Germany

17:00 - 17:30
202 Evolution of National Self-sufficiency in Haemotherapies in Malta – From Aspiration to Achievement

Alex Aquilina, Director, Maltese National Blood Transfusion Service

17:30 - 18:00
203 Improved Concept for Process Validation Stage 1 (Process Design)

Lars Sejergaard et al, Novo Nordisk A/S, Bagsvaerd, Denmark

18:00 - 18:30
Coffee break
18:30 - 19:00
204 Technology Transfer and Change Management – Case Studies

Estelle Darnon & Anne Bajon, LFB Biomedicaments, Les Ulis, France

19:00 - 19:30
205 Global Manufacturing Technology Transfer: the R&D Contribution

Robert Forrest et al, CSL Behring (Australia) Pty Ltd, Melbourne, Australia

Wednesday 17 May 2017
Session 3 Pathogen Safety
Chair: Albrecht Gröner, Pathoguard Consulting, Germany
08:30 - 09:00
301 Source Plasma Safety

George B Schreiber, Plasma Protein Therapeutics Association Annapolis,MD USA

09:00 - 09:30
302 Epidemiology of New Emerging Viruses and Impact on Pathogen Safety of Plasma Derived Products

Albrecht Gröner, PathoGuard Consult, Germany

09:30 - 10:00
303 Confirmation of Effective Virus Clearance of Emerging Pathogens

Nathan J. Roth et al, CSL Behring , Switzerland, Germany & Australia

10:00 - 10:30
Coffee break
10:30 - 11:00
304 Understanding Virus Filtration Mechanisms and Designing Robust Virus Filtration Processes

Tomoko Hongo-Hirasaki, Asahi Kasei Medical Co., Ltd., Nobeoka-city, Miyazaki, Japan

11:00 - 11:30
305 Diagnostic Assays for Variant Creutzfeldt-Jakob Disease-challenges Facing Appropriate Selection Criteria

Jillian K. Cooper, NIBSC, South Mimms, Hertfordshire, United Kingdom

11:30 - 12:00
306 Pharmacovigilance in Blood / Plasma Derived Biologics / Business as Usual or What? / Experiences from ~5 years Working Under the Revised EUPV Legislation

Rainer Schmeidl, Corporate Drug Safety / EU QPPV, Biotest AG, Dreieich, Germany

12:00 - 13:00
Lunch break
13:00 - 15:30
Palazzo Parisio Tour
15:30 - 17:00
Poster Session
Session 4 Applications of Plasma Products and Clinical Developments
Chair: Merche Faro, Instituto Grifols S.A., Spain
17:00 - 17:30
401 Biochemical Properties and Stability of CUVITRU, a Launched 20% Subcutaneously Administrable Immunoglobulin Preparation from Human Plasma

Harald Arno Butterweck et al, Shire, Vienna, Austria

17:30 - 18:00
402 Development of a Novel Polyclonal Antibody Preparation for the Treatment of Patients with Severe Community-acquired Pneumonia

Joerg Schuettrumpf et al, Biotest AG, Dreieich, Germany

18:00 - 18:30
403 Feasibility to Nebulize and to Topically Apply Human Plasma-derived Immunoglobulins into the Lungs

Cedric Vonarburg et al, CSL Behring AG, Bern, Switzerland, PARI Pharma GmbH, Gräfelfing, Germany and Medizinische Hochschule Hannover, Hannover, Germany

18:30 - 19:00
Coffee break
19:00 - 19:30
404 Development of Inter-alpha Inhibitors as A Novel Neuroprotective Agent in Hypoxic-Ischemic Brain Injury

Yow-Pin Lim, ProThera Biologics, Providence, RI, USA

19:30 - 20:00
405 IVIG-inspired Drugs for Improved Therapy in Autoimmune Diseases

Carlos J. Bosques

20:00 - 20:30
406 Use of SOMAscan as an Analytical Tool for the Plasma Fractionation Industry

Karl McCann et al, CSL Behring (Australia), Broadmeadows, Australia

Free evening
Thursday 18 May 2017
Session 5 Markets, Policies and Strategy
Chair: John Curling, John Curling Consulting AB, Sweden
08:30 - 09:00
501 The World Needs Plasma: From The USA And Other Countries

Jan M Bult, Plasma Protein Therapeutics Association

09:00 - 09:30
502 The Nordic Market: Is the Supply of Plasma Products Secured?

Leni von Bonsdorff,  Sanquin Oy, Espoo, Finland

09:30 - 10:00
503 Local Fractionation – An African Model

David Stubbings, National Bioproducts Institute, Pinetown, South Africa

10:00 - 10:30
Coffee break
10:30 - 11:00
504 The Successes, and the Failures, of the Plasma Fractionation Industry

 Albert Farrugia,  Kedrion Biopharma, Lucca, Italy

11:00 - 11:30
505 Plasma Protein Fractionation, a Leading Example for Ecological Footprint Awareness?

Thijs Groenewegen*, Bas Stevens, Anita Oosterveld-Janssen, and Marcel Raedts, Proxcys b.v., Nieuw-Amsterdam, The Netherlands

11:30 - 12:30
Focus Lecture

"Darwin’s Medicine: How Business Models are Evolving in the Life Sciences Industry" 

Focus lecturer: Professor Brian D. Smith, Pragmedic, United Kingdom
12:30 - 14:00
Lunch break
Session 6 New Products & Innovations in Plasma Processing
Chair: Sami Chtourou, LFB Biotechnologies, France
14:00 - 14:30
601 Fc Multimers as IVIG Mimetics — Potential Next Generation Biologics

Fabian Käsermann et al, CSL Behring, Bern, Switzerland

14:30 - 15:00
602 Generation and characterization of a Novel Thrombin-activable Factor X Correcting Factor VIII, Factor IX and Factor XI Deficiencies

Jean-Luc Plantier et al, LFB Biotechnologies, Loos, France

15:00 - 15:30
603 In Vivo Efficacy of an Innovative Biological Fibrin Glue Containing Fibrinogen and Activated Factor VII (FVIIa)

Philippe Mondon et al, University Hospital of Lille, Lille, France, Hopitaux Universitaires de Genève, Genève, Suisse and   LFB Biotechnologies, Loos, France

15:30 - 16:00
Coffee break
16:00 - 16:30
604 Eshmuno® P anti-A and Anti-B: Affinity Resins for Removal of Anti-A and Anti-B Isoagglutinins

Santosh B. Rahane et al, EMD Millipore Corp. Bedford, MA, USA

16:30 - 17:00
605 Streamlined Quantification and Identification Analysis in Plasma Fractionation using Surface Plasmon Resonance

Fredrik Sundberg et al, GE Healthcare, Uppsala, Sweden

17:00 - 17:30
606 Continuous Process Robustness Improvement with Regard to the Process Parameter pH– An Approach beyond DoE and QbD

Harald Arno Butterweck, Shire, Vienna, Austria

17:30 - 17:45
Closing remarks
Conference chair: Joseph Bertolini, CSL Behring, Australia
19:00 - 22:00
Closing dinner