Medicon Valley Alliance and ViruSure & Asahi Kasei would like to welcome you to a Boost Seminar on 24th of September 2025.
Biosafety testing and virus filtration are critical pillars in safeguarding the quality and safety of biopharmaceutical products. This seminar will explore the evolving landscape of virus safety, with a focus on emerging technologies, filtration mechanisms, and the latest regulatory developments shaping the future of virus safety testing and filtration.
The first session will focus on the practical application of the ICH Q5A (R2) guideline, a key reference for virus safety evaluation of biotechnology-derived products. The updated guideline represents a shift in regulatory expectations, particularly with the inclusion of Next Generation Sequencing (NGS) for adventitious virus detection. We will explore the potential of NGS, its advantages, and implementation strategies in virus safety testing.
In the second session, we shift to downstream bioprocessing, where virus removal filters are essential for ensuring the safety of the final product. You will be introduced to virus filters produced by Asahi Kasei Life Sciences, including key features of high-flux, high-capacity hollow fiber filters. We will examine filtration mechanisms, performance characteristics under different conditions, and operating procedures, with the aim to provide guidance for selecting the most appropriate virus removal filter for specific processes in biopharmaceutical manufacturing.
The seminar is tailored for biotechnology companies developing their own products, CDMOs and pharma companies with focus on operational leaders (USP, DSP, manufacturing), regulatory professionals, quality control experts, scientists and consultants seeking in-depth knowledge and practical insights into biosafety testing and virus filtration technologies.
Date: Wednesday 24th September 2025
Time: 08:30 – 15:30
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 08:30 | Networking, registration and light refreshments |
| 09:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 09:05 | Welcome and Introduction to ViruSure & Asahi Kasei Bioprocess Katy Lorineau, Scientific Officer ViruSure Roya Dayani, Head of Product Management, Asahi Kasei Bioprocess |
| 09:15 | Practical Considerations in Application of the new ICH Q5A (R2) to Ensure Virus Safety of Biological Products Katy Lorineau, Scientific Officer ViruSure |
| 09:50 | NGS as a Powerful Tool to Overcome the Limitations of Traditional in vitro and in vivo Methods for Virus Detection Katy Lorineau, Scientific Officer ViruSure |
| 10:25 | Q&A Session and Open Discussion |
| 10:30 | Coffee Break & Networking |
| 10:50 | Introduction of Planova Virus Removal Filters Roya Dayani, Head of Product Management, Asahi Kasei Bioprocess |
| 11:30 | Demonstration of Planova Handling Procedure Pinar Carkci, Senior Product Manager, Asahi Kasei Bioprocess |
| 12:10 | Q&A Session and Open Discussion |
| 12:15 | Light Lunch/Refreshments and Mingle |
| 12:35 | 1:1 Meetings |
| 15:30 | End of 1:1 Meetings |
Speakers
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Katy Lorineau, Scientific Officer ViruSure
Katy Lorineau is a Scientific Officer at ViruSure in Vienna, where she began in 2006 as a GLP Study Director and later became Head of GLP Validation Studies. In her current role, she takes part in consultancy activities to support biopharmaceutical companies in implementing robust virus safety strategies for their downstream processes. She contributes to the promotion of prion and viral safety by delivering internal and external training as well as leading the establishment of a BSL-3 laboratory for HIV studies within ViruSure.
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Roya Dayani, Head of Product Management (Benelux, Nordics & South Europe) Asahi Kasei Bioprocess
Roya Dayani has more than 15 years experience in application of Planova virus removal filters in downstream processing (DSP) of biopharmaceuticals. As Head of Product Management (Benelux, Nordics & South Europe) she is responsible for pre and after-sales services and business development. Together with her team she aims providing the best customer support at every stage of drug development.
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Pinar Carkci, Senior Product Manager, Asahi Kasei Bioprocess
Pinar Carkci has been working for the Japanese company Asahi Kasei Bioprocess for 8 years. She is a specialist in virus removal filtration. Within Asahi Kasei Bioprocess, Pinar is the Senior Product Manager in charge of technical support and business development in Europe. Before joining Asahi Kasei Bioprocess, she worked for Tosoh Bioscience, giving technical and scientific support for diagnostic systems as a Junior Application Specialist.
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