ADVANCE Webinar – Manufacturing of ATMPs

ADVANCE is an innovative and focused learning programme for future advanced therapies developers. This scientific webinar of the last ADVANCE Webinar series will present an overview of important aspects of ATMP manufacturing.

Over the past decade, cell & gene therapy has evolved into clinical reality with several products reaching the market. Being part of the innovative class of advanced therapy medicinal products (ATMPs), cell & gene therapy products provide novel treatment options for otherwise untreatable disorders in multiple fields of medicine. Previously untreatable diseases can now be cured or at least halted with single intravenous injections of gene therapy vectors or viral vector corrected cells. In the years to come, cell & gene therapy (and ATMPs in general) will become an intrinsic part of our standard armamentarium to treat human disease. In this webinar, we will discuss some of the technologies underpinning the silent revolution of the past few decades and review the critical discoveries, milestones and lessons learned in the development and clinical & industrial translation of cell & gene therapies. We touch upon the current portfolio of cell & gene therapeutic tools and discuss some of the success stories available on the market, as well as where challenges still lie, with a focus on (personalized) manufacturing, quality control, and cost of goods.

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SPEAKERS

Rik Gijsbers, KU Leuven

Prof. Dr. Rik Gijsbers is trained as bioscience engineer in cell- & gene-technology. He is associate professor at the Faculty of Medicine and PI at the Laboratory for Molecular Virology and Gene Therapy (LMVGT, Department of Pharmaceutical and Pharmacological Sciences) at the KU Leuven and is responsible for the day-to-day management and scientific innovation of the Leuven Viral Vector Core (LVVC, established in 2010 at the Faculty of Medicine). His research focusses on

• engineering gene therapeutic approaches using viral vector technology,
• employing these tools for target identification and validation (molecular medicine) for rare genetic disorders,
• and technology development to improve viral vector production and purification.

Via the LVVC core facility a platform is available for molecular imaging, target identification and validation, and to develop both cell and small animal models using different viral vector-based technology platforms (RV, LV and rAAV – www.lvvc.be).

Jan Schrooten, Antleron

Dr. ir. Jan Schrooten is co-founder and CEO of Antleron, an R&D company on a mission to enable personalized manufacturing 4.0 of advanced therapies. Antleron integrates innovative technologies like 3D printing with engineered cell-production processes in bioreactors and digital process control & optimization into factories-of-the-future for cell therapy, vaccine- and tissue-manufacturing. Jan Schrooten is board member of flanders.bio and MEDVIA, respectively the cluster organisation for the life sciences sector in Flanders and the industry driven public private partnership with the Flemish government to stimulate healthcare innovations. Previously Jan Schrooten was senior research manager at KU Leuven, responsible for the long-term management and technology transfer of biomaterials and tissue engineering research. He also co-founded and managed Prometheus, the KU Leuven R&D division of Skeletal Tissue Engineering. Trained as a materials engineer, with an engineering PhD in biomaterials and a postgraduate in business administration, he scientifically focused on translational regenerative medicine, with special attention for tissue engineering applications.

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