15:00 -18:30  REGISTRATION & COCKTAIL

8:30 Registration

9:30 Opening Remarks

Mr. Yutaka Shibata, President of Asahi Kasei Medical Co., Ltd., Japan

CHAIRPERSON: Herbert Dichtelmüller Ph.D., Director of Virus Validation,
Biotest AG, Germany

9:45 - The Goal of Increasing Safety in Different Plasma Derivative Manufacturing Processes: 15 Years Experience of Grifols with Planova™ Nanofilt

Santiago Caballero, Ph.D., Biology, Head of Virus Validation Section (R&D),
Instituto Grifols, S.A., Spain 

10:15 - Experience with Reduction of Small Non-enveloped Viruses

Johannes Blümel, Ph.D., Head of virus safety section,
Paul Ehrlich Institute, Germany

10:45 - COFFEE BREAK

11:15 -Consistent and Reliable 100% Retrovirus Removal by Planova™ 20N filter: Demonstration of Robust Log Reduction (>6.0) by Co-spiking Study

Dayue Chen, Ph.D., Virology Group Bioprocess Research and Development,
Eli Lilly and Company, USA

11:45 - Selection of a Virus Filter for a Plasma Product

Shirley Stagg, Ph.D., Senior Project Scientist, Biosafety and Product Development,
Bio Products Laboratory Ltd. (BPL), UK

12:15 - LUNCH

13:15 - Comparison of Downscale and Process Virus Retentive Filter

Marcel Asper, Ph.D., Study Director,
Charles River Biopharmaceutical Services GmbH, Germany

13:45 - Host Cell Protein (HCP) Removal by QyuSpeed™ D: Buffer Type Dependence and Two-Dimensional Electrophoresis (2DE) Profiling

Hironobu Shirataki, Ph.D., Manager, Technology Development Department,
Asahi Kasei Medical Co., Ltd., Bioprocess Division, Japan

14:15 - COFFEE BREAK

14:45 - Virus Removal by Adsorber Membrane QyuSpeed™ D

Eckhard Flechsig, Ph.D., Head of Virus Validation,
Biotest AG, Germany

15:15 - An Evaluation of the Removal of Porcine Circovirus by the Asahi Planova™15N, 20N, BioEX and QyuSpeed™ D (Membrane Absorber) Filtration Devices

Andy Bailey, Ph.D., CEO,
ViruSure GmbH, Austria

(120min) Demonstration of Automated Systems at the COLOGNE TECHNICAL CENTER,  There will be two groups. One on Wednesday and the other on Thursday. Please register.

at the   KÖLN SKY over the Top of the City

Session B: Process Validation / Optimization / Production

CHAIRPERSON: Michael Dieterle, Ph. D., Associate Director Downstream Development Process Science Biopharmaceuticals,
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

9:30 - Virus Inactivation at Low pH: Impact of Buffers, pH Value, Protein Concentration and Temperature on the Inactivation of Retroviruses

Michael Dieterle, Ph. D., Associate Director Downstream Development,
Boehringer Ingelheim GmbH&Co.KG, Germany

10:00 - Process Designing for Virus Removal Filter

Tomoko Hongo-Hirasaki, Ph.D., Manager, Technology Development Department,
Asahi Kasei Medical Co., Ltd., Bioprocess Division, Japan

10:30 - COFFEE BREAK

11:00 - Use of In-house Platform Data to Support Reduced Viral Clearance Validation

Stefan Hepbildikler, Ph.D., Director Recovery &Downstream Processing C,
Roche Pharma Biotech Development, Germany

11:30 - Implementation of Quality by Design to Nanofiltration of Plasma Products

Monique Ollivier, Ph.D., Head of Process Development,
Laboratoire Français du Fractionnement et des Biotechnologies (LFB), France

12:00 - Development & Comparability Data for QyuSpeed™ D Implementation in an Existing GMP Production Process of a Recombinant API

Iann Rancé, Ph.D., Director Process Development-Downstream & Analytics,
Cytheris S.A., France

12:30 - LUNCH

13:30 - FULL PLASTICS for a 1000L Disposable Production Line for Generic Antibody Manufacturing

Peter Rogge, Director DSP Production,
Rentschler Biotechnologie GmbH, Germany

14:00 - Implementation of Automatic Cleaning and Integrity Testing of Planova™ Filters at Sanquin Plasma Products

J.F. van de Laar, M.Sc., Plasma Products, Dept. of Process Support and Development,
Sanquin, The Netherlands

14:30 - New Concept of Integrity Test for Planova™ BioEX

Shinya Sekine, Manager, Technology Development Department,
Asahi Kasei Medical Co., Ltd., Bioprocess Division, Japan

by Mr. Takashi Tsuboi, Managing Director Asahi Kasei Bioprocess Europe N.V./S.A

(120 min.) Demonstration of Automated Systems at the COLOGNE TECHNICAL CENTER,  There will be two groups. This the second group date. Please register.