Strategies for streamlined manufacturing and analytics in CGT development

Tuesday 14:00 BST / 15:00 CEST / 15:00 EET / 16:00 EAT / 17:00 +04

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Strategies for streamlined manufacturing and analytics in CGT development

Navigating the path from CGT discovery to market approval can be complex, with challenges in regulatory landscapes, process scalability, and analytical consistency. This webinar will show how to replace fragmented workflows and manual processes with flexible yet standardized manufacturing and analytics processes that adapt as therapies progress through the pipeline.

During the session, we will explore practical strategies to overcome key bottlenecks and enhance efficiency, standardization, and scalability. Attendees will learn how integrated manufacturing and analytical solutions can help address common roadblocks, support regulatory compliance, and reduce time to commercialization.

Discover strategies to overcome critical pain points in CGT process development and commercialization
Enhance efficiency and standardization with automation, integration, and scalability while preserving flexibility
Explore how to customize cell processing and QC workflows to meet specific needs
Gain insights into comprehensive support strategies for LVV and CGT product development

Laura Mueller

Group Leader CGT Analytics at Miltenyi Biotec

Laura Mara Müller joined Miltenyi Biotec in 2021, where she leads the Cell & Gene Therapy analytics application team. Together with R&D, she drives projects and innovations to advance the development of tools that enable reliable and standardized CGT analytics.

Laura is a molecular biologist with experience in stem cell biology for seven years. She conducted her PhD studies at the Max Delbrück Center for Molecular Medicine in Berlin. Laura completed her postdoctoral research at King's College London gaining profound knowledge in gene editing and cell therapy developments for diseases such as diabetes.

Silvio Weber

Scientific Director of the Industrial Workflow Development at Miltenyi Biotec

Silvio Weber is the Scientific Director of the Industrial Workflow Development Team at Miltenyi Biotec being responsible to provide automated Cell and Gene Therapy procedures on the CliniMACS Prodigy® for industrial customers.

He has more than 15 years of R&D experience in various fields of cell biology, including Immunology, regenerative medicine and pharmacology. After joining Miltenyi, Silvio has been coordinating custom-tailored development of automated processes for T-cell mediated Immunotherapy, stem cell engineering and other innovative Cell and Gene Therapy approaches using the Miltenyi Biotec CliniMACS Prodigy platform.

Silvio holds a diploma degree in biochemistry from the University of Bielefeld and a doctoral degree in Biochemistry from the University of Kiel.

Dirk Windgassen

Group Leader Assay Development at Miltenyi Bioindustry

Dirk Windgassen, PhD, is a results-oriented leader with deep expertise in process and assay development for molecular diagnostics and cell therapy. He currently leads the Miltenyi Bioindustry Assay Development group, driving innovation in San Jose, CA.

Previously, he led teams at Exact Sciences and Thermo Fisher Scientific, ensuring successful market launch of novel molecular assays. His experience extends to cell therapies, having played a key role in the BLA submission for Provenge®, a pioneering cellular immunotherapy, at Dendreon.

Dirk holds a PhD in bioprocess engineering from the University of Erlangen-Nuremberg and completed his doctoral thesis on ex vivo T cell expansion at Northwestern University.