Medicon Valley Alliance and Svar Life Science would like to welcome you to a Good Morning Meeting 21st of October 2025.
As regulatory expectations continue to evolve, the demand for potency assays that accurately reflect a drug’s mechanism of action has never been greater. Potency must be tightly controlled, recognized as a critical quality attribute (CQA), since even minor deviations can impact patient safety and therapeutic efficacy. Increasingly, cell-based assays are favored for their ability to deliver functional relevance, reproducibility, and alignment with regulatory standards, particularly for complex modalities like cell and gene therapies.
Join us for this Good Morning Meeting, where Svar Life Science and AGC Biologics will share insights into the strategic development of potency assays across the drug development lifecycle. We’ll explore how early-stage flexibility transitions into late-stage regulatory rigor, and present a case study where a multi-day cell assay was successfully transformed into a robust, five-hour QC-ready method using cryopreserved, assay-ready cells—demonstrating how innovation can accelerate timelines without compromising quality.
This session will highlight practical approaches to building efficiency into bioanalytical strategies, supporting faster and more reliable pathways from discovery to patient. Whether you’re navigating early-stage candidate screening or preparing for GMP lot release, you’ll gain actionable insights into designing potency assays that are both scientifically rigorous and operationally efficient.
Date: Tuesday, 21st October 2025
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Svar Life Science introduction & updates Anne Thjømøe, Chief Executive Director, Svar Life Science |
| 9:10 | Potency and cell-based asssys – why it’s a match made in heaven Therese Segerstein, Portfolio Director, Svar Life Science |
| 9:30 | Keeping it simple: Making A Cell-Based Potency Assays Work Better for QC Peter Betz Wolff, Ph.D. Senior Scientist, Analytical Development, AGC Biologics |
| 10:10 | Q&A |
| 10:30 | Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Peter Betz Wolff, Ph.D. Senior Scientist, Analytical Development, AGC Biologics Peter Betz Wolff is a Senior Scientist at AGC Biologics, bringing over two decades of experience in the biopharmaceutical industry. He has specialized in the development of cell-based potency assays and currently works within the Analytical Bioassay Development group. Peter is responsible for designing, optimizing, and implementing robust analytical methods for release testing, with a strong focus on regulatory compliance and ease of use. His work is grounded in rigorous statistical analysis to ensure seamless method transfer to the QC department. Peter holds a Ph.D. in Molecular Biology and Biochemistry and has contributed to advancing analytical standards across multiple therapeutic platforms. |
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Anne Thjømøe, Chief Executive Director, Svar Life Science Anne Thjømøe became CEO of the Svar Group in September 2022. Before then she was the CEO of Svar subsidiary Calpro AS since 2014. Anne has extensive management experience and has been heading functions such as Finance, HR, IT, Commercial services and Sales and Marketing. She holds a Master of Business and Economics from BI Norwegian Business School and has experience from various industries, such as manufacturing, finance, insurance and enterprise federations. She has also held various board positions. |
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Therese Segerstein, Portfolio Director, Svar Life Science Therese Segerstein is Portfolio Director at Svar Life Science AB, a role she has held since March 2022. She joined the company in 2017 as Product Manager and brings over 15 years of experience in product management and marketing within the life science and medical device industries. Prior to joining Svar, she held international product management roles at Mediplast AB and HemoCue AB, and earlier positions at LifeAssays AB. Her career spans both global and regional markets, with a strong focus on diagnostic solutions and customer-centric innovation. Therese holds a Master of Science in Biotechnology from the Faculty of Engineering at Lund University. |
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