Development Of A Universal, GMP-Ready, Clonal HEK293 Cell Line For The Manufacturing Of Adeno-Associated Virus, Lenti- And Adenoviral Vectors

SK pharmteco has successfully developed a novel HEK293 cell line optimized for suspension culture and viral vector production. This cell line, derived from the established Frank Graham HEK293 cell line, was adapted to thrive in animal component-free conditions, demonstrating comparable AAV vector yields to commercially available suspension HEK293 cell lines.

To ensure GMP compliance, the cell line was clonally derived using the Cytena f.sight cell printing and CloneSelect imaging platform, enabling full traceability from single-cell to scale-up. The selected lead clone, 4G9, exhibited robust viral production across various platforms, including AAV, LVV, and Adenovirus. Notably, the 4G9 clone accommodated a wide range of AAV serotypes and Lentiviral CAR-Ts, highlighting its versatility.

The establishment of a cGMP master cell bank for large-scale AAV manufacturing is currently underway, with availability anticipated in 2024. This advancement is expected to significantly reduce the cost of viral vector production. With integrated process and analytical development, coupled with commercial-scale manufacturing capabilities, SK pharmteco is poised to streamline the entire production process.