Cell-derived nanoparticles: a new paradigm for CAR-T cell activation and manufacturing

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Cell-derived nanoparticles: a new paradigm for CAR-T cell activation and manufacturing

Activation is the rate-limiting step in the manufacture of CAR-T and other genetically modified T cell therapies, with downstream consequences for vein-to-vein time, product quality, and cost of goods. This webinar presents mechanistic and clinical data on cell-derived nanoparticle (CDNP)-based T cell activation as an alternative to synthetic and soluble antibody/cytokine systems, with a focus on what the data mean for translational and commercial manufacturing programs.

Speakers will present emerging trends shaping next-generation cell therapies (e.g., construct design, non-viral gene delivery such as electroporation). As programs become more complex, control of activation kinetics and cell phenotype emerges as a key determinant of manufacturing success and clinical performance.

The session will highlight quantitative activation kinetics, phenotypic profiling, and in vivo potency data alongside real-world manufacturing outcomes, including clinical evidence from CDNP-based activation (NCT04684563, huCART19-IL18).

A presenter from Ori Biotech will discuss how Synecta^TMperforms in automated, closed systems with a dynamic culture system. Attend this webinar to:

Examine mechanistic and kinetic data showing how Synecta simulates the immunological synapse to drive earlier, more complete T cell activation (e.g., CD25 kinetics), reduced exhaustion markers, and favorable memory subset distribution (e.g., improved central memory (CD62L))
See how the automated, closed-system manufacturing IRO^®’s dynamic mixing improves lentiviral transduction efficiency and total CAR-T yield to enable rapid manufacturing
Review manufacturing data demonstrating faster time-to-target dose (3 days), elimination of de-beading and exogenous cytokines, improved lot-to-lot consistency, and successful expansion of difficult-to-grow clinical samples that fail under standard bead-based protocols
Assess in vivo potency and clinical durability data, including persistence outcomes from NCT04684563, to evaluate how CDNP-based activation translates from bench to patient
Understand how to leverage an FDA-accepted DMF and BlueWhale’s and Ori’s FDA AMT designations to de-risk regulatory submissions for programs adopting next-generation manufacturing

Pedro Moura

Senior Vice President, Head of Technology at BlueWhale Bio

Pedro Moura is Senior Vice President, Head of Technology at BlueWhale Bio, bringing more than 20 years of experience across biologics, vaccines, and gene therapy manufacturing and CMC. He is a strategic technical leader with a track record of building and scaling manufacturing platforms, driving process characterization and validation, and improving productivity and cost through data driven, modern manufacturing approaches. Most recently, Pedro served as Senior Director and Head of Vaccines Platform Technology at GlaxoSmithKline, where he led global manufacturing technology strategy across MSAT, R&D, quality, and supply chain. Prior to GSK, he was Senior Director and Head of Upstream Process Development at Spark Therapeutics (Roche), leading vector, cell line, and cell culture process development from early development through commercial filing. Earlier in his career, he held senior technical and commercialization roles at Merck & Co., supporting the launch of multiple marketed vaccines and biologics and global regulatory submissions. Pedro holds a PhD in Microbiology and Immunology from Albert Einstein College of Medicine and Columbia University and a BS in Biochemistry and Molecular Biology from Fairfield University.

Brian Shy

Director of the Human Islet and Cellular Transplantation GMP Facility (HICTF), UCSF

Brian Shy is an Assistant Professor in the Department of Laboratory Medicine at the University of California, San Francisco (UCSF), a Visiting Investigator at the Gladstone–UCSF Institute of Genomic Immunology, and Director of the UCSF Investigational Cell Therapy Program. His work focuses on advancing next-generation cell therapies through the integration of genome and epigenome engineering, with the goal of improving the safety, potency, and manufacturability of engineered immune cells. His research spans the development of novel therapeutic strategies across cancer, immune disorders, and infectious disease. At UCSF, Brian leads a multidisciplinary effort that brings together research, manufacturing, and clinical translation to accelerate the development and delivery of cell therapies to patients.

Ke Li

Scientific Director of the Investigational Cellular Therapy Program, UCSF

Ke Li is an Assistant Professional Researcher at the University of California, San Francisco (UCSF), where his work focuses on immune cell engineering and the development of next-generation cell therapies. He completed his Ph.D. in Molecular Genetics at Albert Einstein College of Medicine and conducted postdoctoral research at UCSF, where he applied proteomic approaches to identify regulators of cellular fitness and cell competition. At UCSF, Ke leads research aimed at translating advances in cell engineering into preclinical applications, with a focus on improving the design and performance of engineered immune cells.

Jessica Weaver

Bioengineer at Ori Biotech

Jessica Weaver is a Bioengineer in the Technical Solutions group at Ori Biotech, where she leads internal studies focused on platform characterization and supports external partners in transferring and optimizing their manufacturing processes onto the IRO^® platform. Jessica brings experience across leading cell therapy and biopharmaceutical organizations, including Century Therapeutics, Merck, and Johnson & Johnson, where she supported process development and manufacturing efforts spanning cell therapies and biologics. Her background includes work in iPSC-based systems, downstream process development, and analytical methods to enable robust and scalable manufacturing. Jessica holds a Bachelor’s degree in Biomedical Engineering from Drexel University.

In 41 Days

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