Advancing non-viral CAR-NK development: LNP engineering insights and cell therapy regulatory trends

Tuesday 09:00 PDT / 12:00 EDT / 16:00 GMT / 17:00 CET

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Advancing non-viral CAR-NK development: LNP engineering insights and cell therapy regulatory trends

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

Gain practical insight into how to design, test, and advance NK cell therapy programs while staying ahead of evolving regulatory expectations. This Live30 session delivers actionable data and regulatory considerations to streamline early-stage development and enable scalability for CAR-NK and iPSC-derived platforms.

Join Sandy Tretbar (Fraunhofer IZI) as she shares real-world learnings from Fraunhofer’s NK cell therapy pipeline. She’ll walk through end-to-end development of CAR-NK processes, including non-viral mRNA-LNP engineering strategies, insights on transient mRNA-based CAR expression in NK cells, delivery optimization, and functional testing using both automated and manual workflows.

You’ll also hear from a senior regulatory science and strategy expert, Limin Wang (Cytiva), who will break down the latest regulatory expectations for cell therapies. Gain clarity on regulatory frameworks governing cell therapy, and the emerging trends shaping regulatory pathways in the US and Europe.

Key takeaways:

Actionable insights from functional testing of mRNA-engineered CAR-NK cells, including transient CAR expression and cytotoxicity outcomes—plus lessons learned from optimizing NK cell transfection and handling.
A clear understanding of regulatory expectations for allogeneic and iPSC-based NK platforms, from CMC requirements to potency standards.
First-hand perspective on Fraunhofer IZI’s approach to regulatory readiness—covering non-viral (mRNA-LNP) engineering, persistence strategies, multi-gene editing, and overcoming hurdles in scalability and compliance.
Practical guidance on how to anticipate regulatory challenges early, align process design with long-term scalability, and manage risk during tech transfer and process evolution.

Sandy Tretbar, PhD

Group Leader, Cell and Molecular Biology Unit at Fraunhofer Institute for Cell Therapy and Immunology (IZI)

Dr. Tretbar is a molecular biologist with a PhD from Leipzig University. She has conducted postdoctoral research in RNA biochemistry at the University of Wisconsin-Madison and in immunology at Martin-Luther-Universität Halle-Wittenberg. Her work focuses on mRNA-based cell and gene therapies, particularly the use of mRNA-LNP platforms for transient and precise engineering of immune cells such as CAR T cells. She is recognized for her contributions to developing safer and scalable cell therapy technologies.

Limin Wang, PhD, RAC

Manager, Regulatory Science and Strategy at Cytiva

Limin is a regulatory professional at Cytiva that partners with scientific and strategic experts across Cytiva to optimize regulatory support for innovation and growth. Particularly, Limin and her team have worked on approaches to enable Cytiva product and their customers to meet regulatory goals.

In 27 Days

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