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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

GE Healthcare to collaborate with G-CON for cell therapy and vector manufacturing

GE Healthcare has announced its collaboration with G-CON manufacturing for developing cleanroom infrastructure to advance its cell therapy and viral vector production needs.

G-CON is a Texas-based company providing prefabricated cleanroom solutions to the pharmaceutical industry. Its combined, flexible, and readily deployable manufacturing platform is suitable for early-stage clinical or commercial production.

By incorporating its modular, end-to-end cell therapy and viral vector technologies and process designs into G-CON’s proprietary cleanroom technology, GE aims to simplify its early-stage cell therapy and viral vector manufacturing efforts.

The collaboration announcement comes just days after 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. Currently the production queues at service providers span from months to years, and therefore many companies are turning towards developing in-house production facilities.

The collaboration will also include cleanroom technology required for manufacturing lentivirus and adeno-associated viral vectors.

The GE and G-CON collaboration will ultimately benefit drug developers and manufacturers as they will be able to purchase their own full production lines and cleanroom environments, which can be housed in a warehouse-type structure. Drug developers can either seek the combined solution for their cell therapy and vector development and production needs or choose the independent solutions.

Catarina Flyborg, General Manager GE’s Cell and Gene Therapy unit commented: “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. 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.”

Source: G-CON Manufacturing and GE Healthcare Announce Collaboration to Advance Early-Stage Cell Therapy and Viral Vector Manufacturing; Press Release