Overcoming the challenges in industrial-scale Lentivirus manufacturing
Lentiviral vectors (LV) face significant challenges in industrial-scale manufacturing for cell and gene therapy applications due to the required dose size and quality of vectors for defined therapies.
The scale-X™ family from Univercells Technologies is the next generation structured fixed-bed bioreactors. They offer unique features, like homogeneous cell distribution, uniform and low-shear media flow, easy implementation of perfusion processes and high cell densities in a reduced volume, contrary to stirred-tank bioreactors and traditional adherence-based technologies.
scale-X bioreactors suited for high productivity, flexible LV production
The study aims to evaluate the productivity during the process transfer of LV production with a HEK293T cell line from a first generation packed-bed bioreactor to the scale-X hydro structured fixed-bed bioreactor and test two different harvest strategies to assess their impact on LV production efficiency in the fixed-bed bioreactors. Moreover, it outlines a non-invasive method for accurate estimation of the cell numbers in a FB bioreactor using metabolite measurements as a complementary approach to direct FB sampling via sample carriers. The results presented in this study demonstrated a 1 log increase in productivity in the scale-X hydro FB bioreactor and an improved functional/physical titer ratio (TU/p24), which constituted the basis for significantly increased LV productivity after process optimization in the scale-X technology.