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PPB05
Crete, Greece
May 9th - 12th, 2005 |
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Program structure
View
the final program.
Keynote
Lecture
"Plasma Protein Products: how
far have we come, how far do we go?"
Dr. Graham D. Sher,
Chief Executive Officer, Canadian Blood Services, Ottawa, ONT,
Canada
Focus
Lecture 1
Comparability Protocols, FDA´s
Perspective and Experience
Dr. Andrew Chang
Div Hematology, FDA, Rockville, MD, USA
Focus Lecture 2
TSE’s and Medicinal Products. Regulatory
aspects in the EU.
Dr. Sol Ruiz
Spanish Medicines Agency, Madrid, Spain
The program of PPB05 will be structured around the
following sessions.
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Main Topic |
Chairman |
Affiliation |
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Product Developments and New Technologies |
Jan Over |
Sanquin Blood Supply Foundation, The Netherlands |
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Recombinant Plasma Proteins |
Joe Bertolini |
CSL Ltd, Australia |
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Manufacturing |
Johan Vandersande |
Baxter Healthcare Corp., USA |
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Pathogen Safety Issues |
Bernard Horowitz |
New York, USA |
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Hyperimmune and Intraveneous IgG |
Wytold Lebing |
Bayer Corp., USA |
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Applications of Plasma Products and Clinical Developments |
Hubert Heinrichs |
ZLB Behring GmbH, Germany |
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Return to Program Structure
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Session
1; Product Developments and New Technologies
Chairman; Jan Over, Sanquin Blood Supply Foundation, The Netherlands
The Product Development and New Technologies session will
primarily focus on leads for developing new plasma proteins for
clinical application, and on the development of new protein purification
technologies and other production technologies applicable in
the area of downstream processing.
Novel applications of already existing production technologies,
as well as innovative improvements of existing protein products
may also qualify for presentation. The same holds for techniques
which can be used for characterising protein products. |
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Session
3; Manufacturing
Chairman; Johan Vandersande, Baxter Healthcare Corp.,
USA
With today's pressures on margins in the plasma business,
the Manufacturing Session should primarily focus on Cost. Therefore
topics should preferably be related to cost reduction such as:
yield improvement, supplies and labor cost reduction through
automation initiatives and efficiency improvement as well as
inventory reduction by cycle time improvement. |
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Session
4; Hyperimmune and Intraveneous IgG
Chairman; Wytold Lebing, Bayer
Corp., USA
This section will explore new uses for both Hyperimmune and
Polyimmune IgG's. Papers on clinical experience with new indications
for IgG's as well as novel and improved dosage forms will be
encouraged. This section will also explore new manufacturing
procedures. With special attention to methodologies which improve
product safety and recovery. |
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Session
5; Pathogen Safety Issues
Chairman; Bernard Horowitz, Horowitz
Consulting, New Yourk, USA
Questions concerning the safety of purified blood derivatives
continue despite their amassing an admirable safety record over
the past 15 years. In addition to frequently explored topics
- emerging threats, new methods of viral inactivation or removal,
and the validity of viral samples used in spiking studies - the
Safety Session of PPB2005 invites presentations that address
the potential threat from vCJD sparked by its recent putative
transmissions by red cell concentrates in the UK. Specifically,
abstracts that address estimates of risk, assays applicable to
blood screening, methods of removal including the development
of specialized affinity resins, validation of high titered materials
used in spiking studies, and cleaning protocols are encouraged |
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