Ninth Internation Meeting
Chia Laguna, Sardinia, Italy 11-15 May 2015

Program

Article in Process Development Forum, June 2017.
From Darwin to Recombinant Fc Multimers


Presentations authorized to show for the delegates at PPB2017

Keynote Lecture; The Vitality of the Plasma Therapeutics Industry

John Perkins

1

Session 1 Pathogen Manufacturing Perspectives

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

102

Optimizing Automated Buffer Management in Plasma Fractionation

Joakim Lundkvist et al, GE Healthcare, Uppsala, Sweden

103

Improving the Purity of Plasma Proteins

Steve Burton et al, Prometic Bioseparations Ltd.

104

Affinity Chromatography, a Robust Technology for the Purification of a rhFVIIa Coagulation Factor

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

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

106

High Viscosity Tangential Flow Filtration (TFF) Applications in IgG

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

2

Session 2 Quality and Regulatory Affairs

201

The German Experience in Policy Evolution for Haemophilia Therapies ‐ From IQWIG to AMNOG to ACCESS

Uwe Schlenkrich, Publisher Haemophilia News, Leipzig Germany

202

Evolution of National Self-sufficiency in Haemotherapies in Malta ‐ From Aspiration to Achievement

Alex Aquilina, Director, Maltese National Blood Transfusion Service

203

Improved Concept for Process Validation Stage 1 (Process Design)

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

204

Technology Transfer and Change Management ‐ Case Studies

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

205

Global Manufacturing Technology Transfer: the R&D Contribution

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

3

Session 3 Pathogen Safety

301

Source Plasma Safety

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

302

Epidemiology of New Emerging Viruses and Impact on Pathogen Safety of Plasma Derived Products

Albrecht Gröner, PathoGuard Consult, Germany

303

Confirmation of Effective Virus Clearance of Emerging Pathogens

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

304

Understanding Virus Filtration Mechanisms and Designing Robust Virus Filtration Processes

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

305

Diagnostic Assays for Variant Creutzfeldt-Jakob Disease-challenges Facing Appropriate Selection Criteria

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

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

4

Session 4 Applications of Plasma Products and Clinical Developments

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

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

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

404

Development of Inter-alpha Inhibitors as A Novel Neuroprotective Agent in Hypoxic-Ischemic Brain Injury

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

405

IVIG-inspired Drugs for Improved Therapy in Autoimmune Diseases

Carlos J. Bosques

406

Use of SOMAscan as an Analytical Tool for the Plasma Fractionation Industry

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

5

Session 5 Markets, Policies and Strategy

501

The World Needs Plasma: From The USA And Other Countries

Jan M Bult, Plasma Protein Therapeutics Association

502

The Nordic Market: Is the Supply of Plasma Products Secured?

Leni von Bonsdorff, Sanquin Oy, Espoo, Finland

503

Local Fractionation ‐ An African Model

David Stubbings, National Bioproducts Institute, Pinetown, South Africa

504

The Successes, and the Failures, of the Plasma Fractionation Industry

Albert Farrugia, Kedrion Biopharma, Lucca, Italy

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

Focus Lecture: Darwin's Medicine: How Business Models are Evolving in the Life Sciences Industry

Brian D. Smith, United Kingdom

6

Session 6 New Products & Innovations in Plasma Processing

601

Fc Multimers as IVIG Mimetics ‐ Potential Next Generation Biologics

Fabian Käsermann et al, CSL Behring, Bern, Switzerland

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

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

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

605

Streamlined Quantification and Identification Analysis in Plasma Fractionation using Surface Plasmon Resonance

Fredrik Sundberg et al, GE Healthcare, Uppsala, Sweden

606

Continuous Process Robustness Improvement with Regard to the Process Parameter pH — An Approach beyond DoE and QbD

Harald Arno Butterweck, Shire, Vienna, Austria

Posters

701

Establishment of a Competitive Enzyme-linked Immunosorbent Assay for the Measurement of Heparin in Plasma Products

Andrea Engelmaier and Alfred Weber*, Shire, Vienna, Austria

702

Sensitive and Specific Measurement of Low Avidity Natural Occurring Immunoglobulin G Antibodies

Alfred Weber et al, Shire, Vienna, Austria

703

Removal of Isoagglutinins from IVIG and Plasma using Affinity Chromatography

Patrick V. Gurgel et al, Prometic Bioseparations Ltd., USA

704

Specific Protein Quantification during Cell Culture and Process Development using SurfacePlasmon Resonance

Fredrik Sundberg* et al, GE Healthcare, Uppsala, Sweden

705

Removal of Isoagglutinins at Large Scale using an Innovative & Patented Oligosaccharides Production Process

Bernard Mandard & Henri Sors*, GlycoBAR, Meylan, France

706

Innovative Hydrophobic Interaction Chromatography (HIC) Resins for Next Generation Molecule Challenges

Ingeborg van Gemeren et al, Thermo Fisher Scientific, Leiden, The Netherlands and Bedford, MA, USA

707

Enabling Custom Solutions for Downstream Processing

Ingeborg van Gemeren et al, Thermo Fisher Scientific, Leiden, The Netherlands and Bedford, MA, USA

708

Purification of Plasma Derived Proteins by Novel Column chromatography Resins

Hironobu Shirataki, Asahi Kasei Medical, Tokyo, Japan

709

Robustness Studies for Albumin Fractionation Process Based on Design of Experiment (DoE)

Seohyeon Kim* et al, Green Cross Corp., Yongin, Korea

710

Measles Neutralizing Antibodies in Patients Receiving IGIV

Martyn Paddick* et al, Bio Products Laboratory Elstree United Kingdom

711

Glycation of Polyclonal IgGs: Effect of Sugar Excipients During Stability Studies

Nicolas Bihoreau et al , LFB Biotechnologies, Les Ulis, France

712

Treatment of Hepatitis E virus (HEV) Particles with Ethanol or Detergent Alters their Physical Behavior During Chon’s Ethanol Fractionation

Hideki Maeno* et al, Japan Blood Products Organization, Kobe, Japan

713

Plasma-derived Products in Ukraine: Current Status and Perspectives

Vitaliy Karbovskyy* and Olexander Makovskiy, Biofarma-Plasma, Bila Tserkva, Ukraine

714

Viral Clearance Study Optimization for Planova Virus Filters and Technical Support by Asahi Kasei

Esha Vyas* et al, Asahi Kasei Bioprocess America, Reston, VA, USA

715

Continuous Chromatography in IgG Purification

Martin Hall et al, GE Healthcare, Uppsala, Sweden

716

An Improved Fc Function Assay Incorporating CMV Antigen-coated Red Blood Cells Generated using the KODE Technology

Owen Tatford et al, CSL Behring (Australia), Broadmeadows, Australia

717

Plasma Protein Fractionation, a Leading Example for Ecological Footprint Awareness?

Thijs Groenewegen et al, Proxcys B.V., Nw-Amsterdam, Netherlands

718

Functional Significance of Physical Attributes in HP-RFC

Marcel Raedts* et al, Proxcys B.V., Nieuw-Amsterdam, Netherlands

719

Suitability Range of Radial Flow Chromatography in Affinity Separation

Marcel Raedts et al, Proxcys b.v. Nw-Amsterdam, Netherlands,

720

Automating Buffer Preparation Through In-line Conditioning for Economical Benefits

Joakim Lundkvist et al, GE Healthcare, Uppsala, Sweden