Title
Journey to commercialization of a complex, biological ancillary material
Conference Dates
February 6 – 10, 2022
Abstract
Raw materials used in the manufacture of cell therapies require robust qualification and characterization studies to ensure safety and understanding of material variability and function, and their effects on the manufacturing process and final product. Many commercially available cell therapy ancillary materials are complex, proprietary materials which challenge a user’s understanding of how to control and evaluate these materials. T cell activation is a critical step in the manufacture of cell therapies such as CAR-T cells, which require precise control over the initiation and termination of the activation stimuli imparted to achieve high level of T cell transduction, as wells as ideal T cell phenotypes and function. We have developed a novel, modular activation reagent named Expamers to provide a more precise control over the timing of T cell activation stimuli compared to current proprietary T cell activation reagents on the market. Expamers are comprised of anti-CD3 and anti- CD28 Fab fragments that are multimerized with the aid of a StrepTactin backbone for efficient CD3 and CD28 crosslinking on the T cell surface.
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Recommended Citation
Lili Belcastro, Norbert Hentschel, and Takeshi Nishiura, "Journey to commercialization of a complex, biological ancillary material" in "Advancing Manufacture of Cell and Gene Therapies VII", Sharon Brownlow, Cell & Gene Therapy Catapult, UK; Sean Palecek, University of Wisconsin, USA; Damian Marshall, Achilles Therapeutics, UK; Fernanda Masri, Cell & Gene Therapy Catapult, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/cellgenetherapies_vii/54