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


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


Session 1 Pathogen Manufacturing Perspectives


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


Optimizing Automated Buffer Management in Plasma Fractionation

Joakim Lundkvist et al, GE Healthcare, Uppsala, Sweden


Improving the Purity of Plasma Proteins

Steve Burton et al, Prometic Bioseparations Ltd.


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

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


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


High Viscosity Tangential Flow Filtration (TFF) Applications in IgG

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


Session 2 Quality and Regulatory Affairs


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

Uwe Schlenkrich, Publisher Haemophilia News, Leipzig Germany


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

Alex Aquilina, Director, Maltese National Blood Transfusion Service


Improved Concept for Process Validation Stage 1 (Process Design)

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


Technology Transfer and Change Management ‐ Case Studies

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


Global Manufacturing Technology Transfer: the R&D Contribution

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


Session 3 Pathogen Safety


Source Plasma Safety

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


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

Albrecht Gröner, PathoGuard Consult, Germany


Confirmation of Effective Virus Clearance of Emerging Pathogens

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


Understanding Virus Filtration Mechanisms and Designing Robust Virus Filtration Processes

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


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

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


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


Session 4 Applications of Plasma Products and Clinical Developments


Biochemical Properties and Stability of CUVITRU, a Launched 20% Subcutaneously Administrable Immunoglobulin Preparation from Human Plasma

Harald Arno Butterweck et al, Shire, Vienna, Austria


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


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


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

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


IVIG-inspired Drugs for Improved Therapy in Autoimmune Diseases

Carlos J. Bosques


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

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


Session 5 Markets, Policies and Strategy


The World Needs Plasma: From The USA And Other Countries

Jan M Bult, Plasma Protein Therapeutics Association


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

Leni von Bonsdorff, Sanquin Oy, Espoo, Finland


Local Fractionation ‐ An African Model

David Stubbings, National Bioproducts Institute, Pinetown, South Africa


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

Albert Farrugia, Kedrion Biopharma, Lucca, Italy


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


Session 6 New Products & Innovations in Plasma Processing


Fc Multimers as IVIG Mimetics ‐ Potential Next Generation Biologics

Fabian Käsermann et al, CSL Behring, Bern, Switzerland


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


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


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


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

Fredrik Sundberg et al, GE Healthcare, Uppsala, Sweden


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

Harald Arno Butterweck, Shire, Vienna, Austria



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

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


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

Alfred Weber et al, Shire, Vienna, Austria


Removal of Isoagglutinins from IVIG and Plasma using Affinity Chromatography

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


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

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


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

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


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


Enabling Custom Solutions for Downstream Processing

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


Purification of Plasma Derived Proteins by Novel Column chromatography Resins

Hironobu Shirataki, Asahi Kasei Medical, Tokyo, Japan


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

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


Measles Neutralizing Antibodies in Patients Receiving IGIV

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


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

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


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


Plasma-derived Products in Ukraine: Current Status and Perspectives

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


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


Continuous Chromatography in IgG Purification

Martin Hall et al, GE Healthcare, Uppsala, Sweden


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


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

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


Functional Significance of Physical Attributes in HP-RFC

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


Suitability Range of Radial Flow Chromatography in Affinity Separation

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


Automating Buffer Preparation Through In-line Conditioning for Economical Benefits

Joakim Lundkvist et al, GE Healthcare, Uppsala, Sweden