Key considerations for selecting raw materials in gene therapy manufacturing: expertise, scalability and compliance

Tuesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Sponsor

Key considerations for selecting raw materials in gene therapy manufacturing: expertise, scalability and compliance

Efficient removal of nucleic acids is essential for achieving high viral titers, reducing residual DNA, and maintaining control over critical quality attributes. In this webinar, experts from Roche – leveraging deep experience in gene therapy and advanced raw material manufacturing at the Penzberg, Germany facility– share practical insights to help process development and manufacturing professionals evaluate and implement new endonuclease technologies with confidence.

Join the webinar for:

A strategic view on gene therapy and raw material standards

The presenters will share a deep dive into industry challenges and opportunities in in vivo gene therapy, detailing the critical requirements for raw materials (e.g., quality, characterization, operational use) and introducing Roche's platform approach and its "plug-and-play" methodology.

A focus on an endonuclease meeting CGT requirements

See a comprehensive look at EndoCleave as a raw material, detailing exactly how this advanced endonuclease meets the stringent quality and performance requirements for advanced therapies.

Benchmarking data you can act on

See head-to-head performance comparisons of a wild-type endonuclease versus Roche’s enzyme.

Scalability insights and manufacturing excellence

Review real-world scale-up data from our Penzberg facility demonstrating robust performance from early development through manufacturing scale. Integration and regulatory strategies Learn from our expert’s experience how to introduce new raw materials into complex manufacturing platforms with minimal disruption. The presenters share key cross-functional and regulatory considerations for successful qualification and documentation when making raw material changes in even late-stage pipeline projects.

Watch the webinar to bring data-driven clarity to raw material decisions and streamline the integration of EndoCleave into running AAV projects.

Amelie Bauer

Senior Scientist - Gene Therapy Cell Culture Process Development at Roche

Amelie Bauer is a Senior Scientist in the Cell Culture Process Development Team within Roche's Gene Therapy Department. She holds a doctorate in virology from Ludwig Maximilians University Munich, where she specialized in the small-scale production and characterization of rAAV vectors. Since joining Roche in 2022, Amelie has been committed to developing and scaling Roche's cell culture platform process from bench to pilot production. As a Science and People Matrix Lead, she leads the Technology and Innovation functional team, focusing on process robustness and continuous improvement through the implementation of advanced technologies.

Ulrike Strauss

Material Science Product Lead - Gene Therapy at Roche

Ulrike Strauss is a senior scientist within Roche's Cell & Gene Therapy department. She holds a Diploma in Chemical Engineering from TH Lund, Sweden, and a PhD in Biotechnology from TU Graz, Austria. Since joining Roche in 2005, she has held key roles, including Analytical Laboratory Manager and Senior Scientist in Manufacturing Science & Technology, where she managed troubleshooting for DSP commercial manufacturing. In 2019, Ulrike led the ADAPT initiative, focusing on Advanced Data Analytics to improve yield and performance in commercial manufacturing. She previously served as a QC Manager at Sandoz GmbH and completed a postdoctoral fellowship at Aventis SA.

Nicholas DePrimo

Director - Cell Culture Process Development at Genentech

Nicholas (Nick) DePrimo is a Director of Cell Culture and Upstream Process Development within Roche Innovation Center - Philadelphia (RICP), which is part of Genentech/Roche. He holds a Master of Science degree from Drexel University along with over 15 years of industry experience spanning early and late phase large molecule and rAAV gene therapy process development, technology transfer, process validation, and commercialization. Nick is a skilled scientist and people leader, currently focused on progressing early and late phase clinical programs through their lifecycle phases within Roche's gene therapy portfolio, using innovative technologies to improve the upstream process, and optimizing workflows in daily operations.

You have registered for this webinar