Insights and Case Studies of GMP Quality Control Testing of ATMPs

Speaker: Dr. Christian Schiller, Deputy Head of ATMP & Biologics, Eurofins BioPharma Product Testing Germany

Short CV: Christian Schiller received his PhD from the Ludwig Maximilian University (LMU) in Munich, Germany. He then spent 8 years as a postdoctoral researcher and lecturer at the Faculties of Biology and Medicine at LMU. During this time, Christian's research focused on immunology and molecular biology. After joining Eurofins BioPharma Product Testing Munich in 2018, he specialised in the development and validation of ELISA, FACS, cell-based methods, qPCR and ddPCR. Christian is currently the Deputy Head of the ATMP & Biologics Testing Department. In addition, he acts as Quality Control Manager and is responsible for all GMP testing in the department using molecular biology methods.

Speaker: Dr. Nicole Rieth, Head of ATMP and Biologics Testing, Eurofins BioPharma Product Testing Germany

Short CV: After her diploma in Biology, with a strong focus on tumor immunology, Nicole Rieth received her PhD from the Ludwig Maximilian University (LMU) in Munich, Germany in 2011. After her work as a senior scientist in a biotechnology company, she held the position of the lead for in vitro pharmacology developing and validating assay formats for proof of concept of two biologic lead candidates at Baxalta and Shire until 2018. She joined Eurofins BioPharma Product Testing Munich in 2018 as a group leader and deputy head of the Immunoanalytics department, further specialising in the development and validation of ELISA, FACS, MSD and cell-based methods. Nicole is currently the Head of the ATMP & Biologics Testing Department.

Speaker: Dr. Nicolò Sacchetti, Cells & Gene Science and Business Manager, Eurofins BioPharma Product Testing Italy

Short CV: Nicolò Sacchetti originally trained as a biochemist at the University of Milan and earned his doctorate in Molecular Medicine from the San Raffaele Telethon Institute for Gene Therapy (SR – TIGET), where he also conducted translational research in development of gene therapy approaches. Transitioning from academia, he first joined AstraZeneca's medical affairs team and later took on business development roles in CDMO and CRO companies, gaining further experience in ATMP development. Currently, Nicolò is the Science and Business Manager at Eurofins CDMO. As a core team member establishing C&G CDMO operations, he provides strategic direction and technical expertise, supporting the growth of the division.

Speaker: Dr. Sylvia May, Scientist, Eurofins BioPharma Product Testing Germany

Short CV: Sylvia May received her PhD from the Johannes Gutenberg university in Mainz, Germany. Afterwards, she joined Eurofins PHAST GmbH and was involved in setting up the BSL2 laboratories in Homburg. She specialised in the development and validation of bioassays such as cell-based methods like ADCC and potency assays, qPCR-based analyses and protein methods like ELISAs, Western Blots and analysis of transfection and protein expression in target cells. Sylvia is currently as Scientist responsible for development of customised bioassays and validation of bioassays in the Eurofins PHAST Bioassay department.

Speaker: Dr. Sabine van der Sanden, Head of Department Eurofins Proxy Laboratories, Eurofins BioPharma Product Testing Netherlands

Short CV: Dr. Sabine van der Sanden received her PhD degree in virology at the Erasmus University Rotterdam in the Netherlands in 2012. From 2012 to 2014 she worked as a postdoctoral researcher at the Centers for Disease Control and Prevention (CDC) in Atlanta (USA), where she genetically engineered an improved poliovirus vaccine manufacturing cell line. From 2012 to 2016, she performed postdoctoral research at the Academic Medical Center of Amsterdam with a focus on virus-host interaction studies in human 3D culture models and development of an immunotherapy against enterovirus infections. Since 2016, she has been applying her knowledge on viruses and viral assays in the field of cell & gene therapy. She worked on exosome mediated delivery of adeno associated virus (AAV) based gene therapy for ocular diseases at the Erasmus Medical Center in Rotterdam. From 2017 until 2022 she led the department of vector development at Arthrogen B.V (acquired by MeiraGTx in 2019), focusing on the design and manufacturing of novel AAV-based vectors targeting inflammatory and heart diseases. Since 2022, she has led the Viral Safety and Cell Banking department at Eurofins Microsafe in the Netherlands, where she oversees the quality and safety testing of biopharmaceutical products, including Advanced Therapy Medicinal Products (ATMPs). Her drive within Eurofins is to keep up to date with latest developments within biopharmaceutical industry and to provide clients with cutting-edge testing solutions.