Scaling non-viral cell therapy approaches for solid tumor treatments

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

Sponsor

Scaling non-viral cell therapy approaches for solid tumor treatments

The need for standardization and high manufacturing success rates are critical drivers of innovation in cell therapy. Thermo Fisher Scientific has built a fit-for-purpose portfolio of modular instrumentation platforms designed to support closed, large-scale cell manufacturing. Importantly, this enables automation of the end-to-end manufacturing workflow, starting from cell isolation and activation, through to genetic-modification and expansion.

Automation of the isolation and activation steps ensures that the manufacturing workflow will be closed at the outset of the process. The Gibco™ CTS™ DynaCellect™ Magnetic Separation System and consumables are thoughtfully designed to achieve this goal with high precision and in a very timely manner, all while supporting large volumes and large cell numbers.

The subsequent transformation of target cells into a functional therapeutic involves a genetic modification step. There has been a renewed interest in nonviral gene modification approaches as an alternative to viral vectors due to the increased focus on personalized therapies and solid tumors. Non-viral electroporation is emerging as the method of choice, especially given demonstrated efficacy, safety benefits, and flexibility of utilizing CRISPR-Cas9 gene editing. The CTS™ Xenon™ Electroporation System is a closed, modular, large-scale device with full control over electroporation parameters delivering improved transfection, cell viability and recovery. The larger volume MultiShot™ consumable supports sterile processing of up to 2.5x109 cells (a volume of 25 mL), and an OPC-UA interface allows connectivity to a 21 CFR Part 11–compliant system. Given the ease of use and superior performance, this approach has the capability of transfecting a large number of cells in a short time with high efficacy.

PACT Pharma has developed a robust single-step, targeted, non-viral method for the manufacturing of personalized adoptive cells therapies for the treatment of solid cancers (NCT03970382). In this process a neoepitope-specific T cell receptor (neoTCR) is precisely inserted into the endogenous locus while simultaneously eliminating the expression of the endogenous TCR. This results in neoTCR-specific T cells in which neoTCR expression is naturally regulated and not impeded by competition for CD3 by the endogenous TCR. Issues associated with retroviral manufacturing are avoided, including cost and dysregulation from random integration. PACT's single-step non-viral precision genome engineering technology is also highly versatile with the ability to knock-out, knock-down, knock-in, and precisely regulate additional genes in a single step. These modifications have the potential to expand the applicability of T cell drug products and are broadly applicable to a variety of other cellular therapies and research models.

During this webinar, we will discuss these critical innovations to the cell therapy manufacturing workflow. Key highlights from our speakers include:

Scaling and automating the cell therapy manufacturing process (Evan)
Safety, regulatory advantages, and performance of nonviral transfection for cell therapy (Nektaria)
A highly efficient non-viral precision genome engineering process to manufacture personalized cell therapies for solid tumors (PACT Pharma)

Nektaria Andronikou

Senior R&D Manager at Thermo Fisher Scientific

Nektaria Andronikou is a Senior R&D Manager for Thermo Fisher Scientific’s Biosciences Division focused on the development and improvement of mechanical based delivery products for use within cell and gene therapy workflows. She currently leads a small team of innovative scientists working with various primary cell models and payload/cargo types (CRISPR, mRNA, DNA, etc.) to improve non-viral based transfection and delivery. Throughout her time at Thermo Fisher Scientific, Nektaria was an integral member of the cross-functional teams that developed the Lipofectamine 3000, MessengerMAX and Invivofectamine 3.0 transfection reagents. She began her professional career at Ionis Pharmaceuticals (formerly ISIS Pharmaceuticals), as a research associate for the Cardiovascular Drug Discovery program. She received a Bachelor of Science in Biochemistry with a minor in Cellular and Molecular Biology from UCSD. She has been with Thermo Fisher for eleven years and has been dedicated to the understanding and commercialization of improving delivery technologies for clinical, translational and research markets.

Evan Zynda PhD

Staff Scientist, Cell Biology at Thermo Fisher Scientific

Dr. Evan Zynda has been with Thermo Fisher Scientific for almost 5 years. He serves as a Senior Scientist in R&D for the department of Cell Culture and Cellular Medicine and has been focused on Cell Therapy process development and product development. He first began studying T cell biology in 2005 at Roswell Park Cancer Institute, where he received a Ph.D. in Molecular and Cellular Biophysics and Biochemistry. During his academic years, he elucidated mechanisms by which tumor cells evade the immune system and went on to apply this knowledge in drug development and cell therapy manufacturing.

Kyle Jacoby PhD

Senior Director of Gene Editing at PACT Pharma, Inc.

Dr. Kyle Jacoby is currently the Senior Director of Gene Editing for PACT Pharma, a personalized adoptive T cell therapy company. The Gene Editing group has developed and characterized a non-viral precision genome engineering method to produce PACT’s clinical cell products.Prior to PACT Pharma, Dr. Jacoby led the technology development group at Seattle Children’s Program for Cell and Gene Therapy. This group was responsible for creating molecular tools and assays for engineered T cell and HSC therapies. His PhD was granted from the University of Washington’s Molecular and Cell Biology program for work on the discovery and characterization of nucleases for genome engineering.