Gene therapy is witnessing explosive growth, with over 600 clinical trials currently underway, representing approximately 32% of the Cell & Gene Therapy trial portfolio.

A significant number of these therapies rely on viral vectors, including adeno-associated virus (AAV) and lentivirus (LV), to effectively deliver genetic material for various diseases.

As the focus shifts towards treating more common, non-rare diseases, the demand for these viral vectors is surging, prompting a need for increased production capacity.

To meet these clinical and commercial demands, there is a notable trend towards scaling up bioreactor volumes to thousands of liters.

However, scaling up production presents technical challenges, such as managing fluid dynamics and ensuring consistent cell lysis, especially in bioreactors that exceed 200 liters.

In response to these challenges, manufacturers are increasingly adopting optimized production platforms that utilize suspension-adapted cell lines, such as HEK293 and Sf9, to enhance efficiency.

To successfully navigate the complexities of large-scale manufacturing, advanced solutions and process innovations are essential for maintaining control and achieving high yields in gene therapy production.