Trends in innovation for downstream process intensification, product yield, single-use closed systems, and gentle ATMP bioprocessing: a KOL panel discussing 2024 insights in gene therapy manufacturing

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In the rapidly evolving landscape of gene therapy manufacturing, it is critical to understand trends and share knowledge. As the industry prepares for the challenges of 2024, this webinar addresses the pressing need for advancements in downstream processes to better accommodate more complex and fragile advanced therapy medicinal products (ATMPs). The timely nature of this topic is underscored by this critical juncture in gene therapy manufacturing, where efficiency gains and intensified processes are paramount.

This panel of scientific thought leaders will delve into key areas of innovation such as more tailored platforms and consumables, process optimization, and automation, highlighting their transformative impact on maximizing product recovery yield. The adoption of single-use solutions, a critical component of the discussion, is explored in the context of ensuring product quality and safety. The specific focus on addressing the unique needs of gene therapy CDMOs will also be addressed.

By attending, you will gain valuable insights into overcoming the challenges inherent in gene therapy manufacturing in its current state. From streamlining processes to enhancing efficiency, this webinar provides a comprehensive exploration of cutting-edge strategies. By engaging with this panel, attendees will gain a nuanced understanding of new solutions driving downstream process development and optimization, positioning them to navigate the evolving landscape with heightened expertise and preparedness.

• Forecast of 2024 downstream process optimization and automation trends for gene therapy development
• Trends in single-use closed systems for end-to-end process and how companies are launching innovations to support manufacturers in meeting these evolving risk mitigation strategies to ensure product quality and safety
• Addressing the unique needs of gene therapy CDMOs during tech transfer - examining solutions designed to optimize this process
• Ensuring a robust and secure supply chain for critical raw materials and the benefits of securing long-term supply agreements

Rachel Legmann

Senior Director of Technology, Gene Therapy at Repligen

Rachel has more than 25 years of experience in the field of scalable biologics and gene therapy manufacturing of therapeutic products, viral vectors and proteins for gene therapy and biologics. She completed her Ph.D. in Food Engineering and Biotechnology at the Technion-Israel Institute of Technology, Israel. Rachel joined Repligen in 2021 as a subject matter expert leading the global gene therapy organization helping customers achieve their technical and operational objectives in their manufacturing of vector-based therapeutics and vaccines with a focus on gene therapy processes including upstream, downstream, analytics and scalability. In addition to supporting global customers and building high level networks, Rachel is supporting various internal cross-functional activities and external collaborations. Prior to joining Repligen, Rachel held several scientific and leadership roles at Microbiology and Molecular Genetics department at Harvard Medical School, CRO SBH Sciences, Seahorse Biosciences part of Agilent, CDMO Goodwin Biotechnology and Pall Corp part of Danaher.

Andrew Tustian

Senior Director, Preclinical Manufacturing and Process Development at Regeneron Pharmaceuticals

Andrew leads the viral vector process development group at Regeneron Pharmaceuticals, focused on developing bioprocesses for Adeno-associated virus (AAV) based viral vectors. Andrew has worked at Regeneron since 2009. Prior to moving to gene therapy Andrew co-led the purification development group for protein therapeutics, working on Fc-fusion, monoclonal antibody, and bispecific processes. He has worked on the process development for the FDA-approved drugs Dupixent®, Libtayo®, Inmazeb™, Kevzara®, Evkeeza™ and Praluent®, and helped develop the bispecific antibody platform at Regeneron. Andrew received his doctorate in biochemical engineering from University College London and his undergraduate masters in biochemistry from the University of Oxford.

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SPEAKERS

Rachel Legmann

Senior Director of Technology, Gene Therapy at Repligen

Andrew Tustian

Senior Director, Preclinical Manufacturing and Process Development at Regeneron Pharmaceuticals

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