The Spanish company says it teams are dedicated to making the manufacturing process more cost-effective, scalable and regulatory compliant.
In June this year, the CDMO opened a new manufacturing plant, with the objective of significantly increasing its production capacities by 400% and delivering its lentiviral vectors (LVVs) on a commercial scale to meet the growing demand for those vectors from the cell and gene therapy (CGT) sector. The San Sebastian plant also sees the installation of the largest bioreactor currently available on the global market, enabling batch size to be increased more than 60 times. The new facility also contains seven cleanrooms specifically set up for viral vector production.
“Along with the increased batch size, facility configuration has been designed in a much more flexible manner. In this new site, we have focused not only in increasing the GMP capacity but also very importantly the initial R&D and process optimization phases capabilities,” VIVEbiotech CEO, Dr Gurutz Linazasoro, told BioPharma-Reporter.
The CDMO has contributed to the development and manufacture of LVVs for more than 30 international projects of 20 different customers for different applications that range from immune-oncology and rare diseases among others, both ex vivo and in vivo use.
“For VIVEbiotech the main objective is that these therapies using LVVs reach the largest number of patients as possible. So it is essential that the LVV production processes are more cost-effective with a titer increase and an enhanced purity that has a great impact on the functionality of lentiviral vectors to transduce the target cell, that they target the cells in a more specific manner so as to have a greater impact in terms of the required multiplicity of infection (MOI).” continued the CEO.