Century recognizes the critical importance of cellular product manufacturing, and is committed to building in-house GMP Operation capabilities and expertise.
Abstract: Throughout development of iPSC-derived immune effector cell therapies, Century recognizes the critical importance of cellular product manufacturing, and is committed to building in-house GMP Operation capabilities and expertise. This investment will not only enable vertical integration of the company, but also bring benefits such as iterative learnings from clinical production, improved probability of success for process and analytical technology transfer, the ability to better troubleshoot problems and optimize processes. Manufacturing processes for allogeneic cell therapies must be scalable, cost-effective, robust, and reproducible in order to fulfill their promise to make products (e.g., CAR-T) affordable and accessible to patients. We will discuss some of the manufacturing challenges that must be surmounted, and some of the strategies and methodologies that could be considered, to enable the successful commercialization of these therapies. These challenges include scaling up cell expansion, harvesting and filling operations; testing of cell banks and final product to ensure patient safety and product quality; and shipping and supply chain logistics for living, cellular products.
Bio: Bruno Marques leads the Process & Product Development team at Century Therapeutics, with a focus on genetically engineered, universal iPSC-derived immune effector cell products (NK, T cells) that target hematologic and solid tumor cancers. Prior to Century, Bruno spent 14 years developing and commercializing biopharmaceutical products at Merck and GlaxoSmithKline, while directing biotechnology industry-related courses at Rutgers University. At GSK, Bruno held leadership roles in process development and portfolio management, contributing to the launch of drugs such as Nucala (mepolizumab). He eventually joined GSK’s Cell & Gene Therapy platform to support autologous immunotherapies as Director of Manufacturing Strategy. Bruno is a Chemical Engineer by training, with a PhD from Carnegie Mellon University and a BS from the Illinois Institute of Technology.