GE Healthcare has begun working with G-CON Manufacturing, makers of prefabricated cleanrooms, to offer a combined and deployable platform for early-stage manufacturing of cell therapies and viral vectors.
G-CON will provide modular cleanroom infrastructure for GE’s clinical and commercial production platforms to help simplify the manufacturing process. The end goal is for drug developers and manufacturers to be able to purchase their own full production lines and cleanroom environments, which can be housed within an “off-the-shelf” warehouse-like building.
“It is well-recognized that the commercialization of the cell therapy industry requires a paradigm shift in manufacturing, because of the highly individual and complex nature of the production process,” Maik Jornitz, G-CON president and CEO, said in a statement.
With production queues at service providers spanning months to years, many innovator companies are weighing the risks and benefits of developing in-house production facilities versus contracting out, or pursuing a mix of both.
“This combination will provide manufacturers with turnkey processing capacities with speed and reliability. Such an approach will remove manufacturing bottlenecks that currently delay production of this critical new class of therapies,” Jornitz added. Both GE Healthcare and G-CON, which previously collaborated on similar processes for vaccine production, will also continue selling their products and services separately.
Last year, GE Healthcare launched its modular FlexFactory line for end-to-end cell therapy production, offering semi-automated and digitized processes at a size that can be installed into G-CON’s scalable, pod-like cleanrooms.
In addition, the collaboration will also include the cleanroom technology required for the manufacture of lentivirus and adeno-associated virus vectors, used as delivery vehicles for gene therapy treatments.
“The combination of the G-CON infrastructure along with GE Healthcare’s cell therapy and vector platform will aid in reducing the time to market for cell therapies that need vector manufacturing to be on-site and connected to the overall therapy workflow,” said Catarina Flyborg, general manager of cell and gene therapy at GE Healthcare.
“It has been designed with early-stage manufacturing processes in mind, which is the much-needed stepping stone for validating large-scale manufacturing and investment decisions in the future,” Flyborg said.
Earlier this month, the FDA said it was expecting a new wave of cell and gene therapy applications in the coming years, projecting at least 200 new IND submissions annually by the end of 2020. By 2025, the agency expects to be approving 10 to 20 therapies each year.
FDA Commissioner Scott Gottlieb and CBER Director Peter Marks outlined plans to hire at least 50 new clinical reviewers focused in the space, as well as issue new guidance, including on how changes in manufacturing techniques for CAR-T therapies can be introduced without sponsors performing new clinical investigations or bridging studies, and instead possibly submit real-world data.