Designing production facilities of the future

Engineered autologous T cell products have proven to be an extremely promising new therapeutic modality, but they are currently time-consuming and costly to manufacture. This presentation will review the history of biotherapeutics development to look for lessons we can learn that may accelerate advances in autologous cell therapy manufacturing. It will also highlight the differences between traditional biotherapeutics manufacture and autologous cell manufacture to identify areas which may require us to look to other industries for inspiration. Finally, it will present an integrated vision for an autologous cell therapy manufacturing facility of the future which incorporates current initiatives, lessons from the past, and ideas from other industries to improve the robustness, cost, and time of autologous cell therapy manufacture.
Presented by Geoffrey Hodge, Chief Technical Officer at Unum Therapeutics

Geoff is responsible for leading the development and execution of Unum’s CMC and technical operations, including process and analytical development, manufacturing, and quality, for the company’s proprietary antibody-coupled T-cell receptor (ACTR) therapies. He has over 25 years of experience in the biotechnology industry, providing bioprocessing technical solutions for companies including Millennium Pharmaceuticals, Genetics Institute (Wyeth), and Alpha-Beta Technology. Prior to joining Unum, Geoff was a co-founder of Xcellerex, inventor on several of Xcellerex’s foundational single-use technology patents, and an operations leader at Xcellerex. He holds an M.S. from WPI and bachelor’s degree from Colgate.
Followed by Enterprise solutions for cell and gene therapy
The cell and gene therapy industry is growing at a rapid pace, with more and more attention on manufacturing rigor and scalability. Solutions are needed to achieve these outcomes while providing the speed and agility to succeed in this dynamic space. To tackle these issues and make life-saving therapies more accessible, the industry needs a new way of thinking. This presentation will discuss approaches that can be applied in modular fashion to create a customized production facility with the flexibility to evolve over time.
Modern facilities include integrated technologies that close and automate processing, delivering the scalability and control lacking in typical manual workflows. An integrated platform can be housed inside a prefabricated structure – a cleanroom or a larger manufacturing facility. Both options allow for quick addition of GMP manufacturing capacity without interrupting existing work. A manufacturing execution system can be added to bring facilities together with cloud-based oversight of what is happening in real time. By weaving in the digital thread from the planning phases, the facility of the future will be primed to use data to continually improve production while controlling costs.
Presented by Gary M. Pigeau, Ph.D., Director – Centre for Advanced Therapeutic Cell Technologies at GE Healthcare

Gary Pigeau received his Ph.D. in Biotechnology from Brock University in St. Catharines, Ontario. He completed a postdoctoral fellowship at the University of Alberta with a visiting scientist appointment at the University of Oxford. Gary moved to private industry in 2008, where his research group focused on process development and scale-up of a proprietary bioprocess technology. He then moved to commercial, large-scale biomanufacturing in 2013. Gary joined GE Healthcare and the Centre for Advanced Therapeutic Cell Technologies (CATCT) @ CCRM in 2016 and led the pluripotent stem cell process development, scale-up and manufacturing efforts. Today, Gary is the GEHC Director of the CATCT delivering on customer-focused fee for service process, media and assay development projects, development of new products for GE Healthcare and internal technology development projects to continue to develop and grow capabilities within the group.
Sponsored by GE Healthcare Life Sciences

At GE Healthcare’s Life Sciences, we accelerate precision medicine by helping researchers, pharmaceutical companies, and clinicians discover and make new medicines and therapies. We provide expertise, technology, and services for the life sciences industry. This includes contrast agent manufacturing for diagnostic imaging, basic cell and protein research, and technologies for large-scale vaccine, biologic, and cell therapy manufacturing.
Cell therapy is emerging as a treatment for challenging diseases, including cancer. Our Cell Therapy business provides the tools, technology, and processes to enable customers from pharmaceutical manufacturing as part of our Cell Processing segment, to clinicians and technicians in our Cell Banking and Point of Care segments. We are investing in the field for the long-term, and partnering with pharma, biotech, and clinical researchers. GE brings expertise in quality, global distribution, R&D, and regulatory that will transform cell therapy from small-scale treatment to a globally accessible personalized medicine.