Webinar - From Bench to Bedside: Development of a Virus-Free Clinical CAR T Manufacturing Protocol

Virus-free gene transfer technologies are gaining increasing attention as the cell therapy field moves toward safer, more scalable, and more cost-efficient manufacturing approaches. For CAR T cell and similar therapies, transposase-mediated gene transfer offers an attractive alternative to viral vectors, but translation from research-scale protocols to clinical manufacturing requires careful process development, validation, and regulatory preparation.

In this context, Minicircle DNA provides a bacterial-backbone-free vector format that is particularly well suited for transposase-based gene transfer into primary cells such as T cells. Compared to conventional plasmid DNA, Minicircles can support more efficient virus-free gene delivery while reducing unwanted bacterial backbone–related sequences.

In this webinar, Dr. Katrin Mestermann, Group leader at Fraunhofer IZI, Würzburg, will present the development of a virus-free CAR T cell manufacturing protocol, from early optimization of transposase-mediated gene transfer to the establishment of an at-scale, GMP-compliant process. The session will cover key considerations for process upscaling, preclinical data package generation, clinical trial application, and manufacturing for patient treatment.

The webinar will also provide perspectives on future CAR T manufacturing concepts, including automation, shortened manufacturing timelines, and the potential application of these approaches to next-generation immune cell therapies.

Learning Objectives

At this webinar, participants will gain insights into:

• • Optimization of a virus-free CAR T cell manufacturing process using transposase-mediated gene transfer

• • Establishment and validation of an at-scale, GMP-compliant manufacturing process

• • Development of a preclinical data package and preparation for clinical trial application

• • Clinical manufacturing of CAR T cells for patient treatment

• • Future applications in next-generation manufacturing, including automation and shortened manufacturing timelines

• • The role of Minicircle DNA as a bacterial-backbone-free vector format for efficient virus-free gene transfer

• • How Minicircle DNA can support transposase-based CAR T cell engineering compared to conventional plasmid DNA

Speaker Bio - Dr. Katrin Mestermann, PhD:

Dr. Katrin Mestermann is Group leader at Fraunhofer IZI, Würzburg. She completed her Master of Science in Biology in Würzburg and received her PhD in 2019 in the Chair of Prof. Michael Hudecek, focusing on the pharmaceutical control of CAR T cells using small molecule inhibitors.

Since then, her work has focused on optimizing lab-scale and clinical-grade manufacturing of CAR T cells, as well as improving CAR T cell function. Working at the interface of scientific research and clinical translation is a key motivation for her. In 2024, she joined the newly established Würzburg branch of Fraunhofer IZI. Since January 2026, she has co-led the GMP Development Unit, where her work focuses on ATMP manufacturing and future applications beyond CAR T cells, including NK cells, macrophages, and other immune cell types.