A dual platform revolutionizing gene therapy manufacturing
February 6 – 10, 2022
Advanced therapies enable for many indications with no current treatment a significant improvement in quality of life and in some cases a chance at life altogether. The commercialization of those breakthrough therapies rely on manufacturing technologies primary developed for the mAbs industry. Indeed, the commercialization of mAb products was accompanied by technology advances reaching high-capacity and cost-effective processes within integrated and continuous solutions. Nevertheless, in contrast with mAbs where the annual demand (in the US) can be estimated between hundreds of grams to hundreds of kilograms, GT products show an annual demand variability of over 7 logs. Currently used technologies present some limitations in reaching the capacity required by high-demand GT indications resulting in process scale-out and related overall performance decrease. As GT developers often endeavor to target numerous indications, the significant variability in annual demand has pushed them to adopt technologies depending on the types of applications, rather than adopting a single flexible technology. As lessons learn from the mAbs industry the development of a flexible technology accommodating most process requirements adapted to GT products could facilitate viral vector manufacturing while accelerating the availability of advanced therapies at reduced costs.
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Tania Pereira Chilima, "A dual platform revolutionizing gene therapy manufacturing" 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/64