The Canadian not-for-profit organization Centre for Commercialization of Regenerative Medicine (CCRM) focuses on developing and commercializing regenerative medicine technologies and cell and gene therapies. Since 2016, they have partnered with GE Healthcare to industrialize and scale those therapies. Advancing cell-based therapies provide hope in advances for many diseases, including cancer, heart disease, neurodegenerative diseases, musculoskeletal disorder, and autoimmune diseases.

At the 2019 World Stem Cell Summit in Miami, FL, GEN sat down with Michael May, PhD, CEO of CCRM and Amit Dua, the global marketing director of cell and gene therapy at GE Healthcare to talk about the latest news from their collaboration, in partnership with the Government of Canada.

A cell therapy clean room in the Centre for Cell and Vector Production (CCVP)

May tells GEN that CCRM has recently launched a Phase I/Phase II GMP facility, the Centre for Cell and Vector production (CCVP), that houses viral vectors manufacturing capacity and eight cell processing suites. “The idea here is to intimately connect the process development capabilities and the team that we built with GE to a clinical phase facility to accelerate clinical trials and clinical validation,” May says. Dua adds, “Customers not only want development, they want the ability to produce Phase I and Phase II vector material.”

GE’s Xuri Cell Expansion System inside the CATCT.

Together, CCRM and GE Healthcare established the Centre for Advanced Therapeutic Cell Technologies (CATCT) in Toronto, Canada with a focus on the industrialization of cell manufacturing. Here, they focus on scaling—for example, the production of 36 billion pluripotent stem cells in a 10 L batch. They also work to improve existing technologies and are currently focused on the development of advanced media customization and other capabilities to optimize cell culture and cell therapy workflows. May tells GEN, “The industry is growing rapidly and GE’s customers are demanding closed, automated, and turnkey manufacturing workflows that will produce high quality, sterile product at a reasonable cost.” Dua adds that their customers frequently have sterility concerns, prompting GE to think about connecting technologies to improve the closed systems that are required.

The CCVP facility is a partnership between CCRM and the Toronto-based University Health Network to enable academic clinical projects and industry projects, including many emerging small companies. This project is designed to support both industry and academia. May says that having a large process development facility tied into a clinical phase manufacturing facility, embedded in a clinical system composed of 10 research hospitals with clinical trial infrastructure, is a key component of their partnership with GE. Dua says that the collaboration is helpful because “innovating technologies in a blackbox is the worst thing they can do.” They appreciate that working with CCRM allows them to innovate in a real-world environment that bridges the gap between research protocols and industrial manufacturing.

In the future, CCRM and GE Healthcare would like to deepen their activities in process analytics, cell engineering, and more complex automation. They would also like to tie commercial scale infrastructure to their existing capabilities in process development and clinical phase manufacturing.

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