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.
The high titer increases transduction efficiency, and the high purity reduces cytotoxicity.
More than a third of VIVEbiotech's budget is invested in R&D and USP/DSP optimization, and those teams are also working on, among other aspects, the development of different pseudotyping strategies, with a strong focus on optimizing purity.
Studies have demonstrated the great impact that a different pseudotyping approach can have on the final functionality of target cells. Commentators says pseudotyping is, and will continue to be, one of the major vector characteristics to be considered on the road to improving LVVs.
What other challenges in viral vector production remain and what is VIVE doing to overcome them?
“It is not only a matter of increasing particles production but also that these particles are more functional. VIVEbiotech is actively working on a dedicated project related to this," said Linazasoro.
Moreover, accurate enumeration of total particle count of gene therapy vectors is critical in order to minimize the risk of adverse immune response or other negative outcomes when treating patients.
In that context, VIVE says it has R&D projects focused on rapid particles counting, along with electronic microscopy analysis and lipidomic characterization work, said the CEO.
VIVE is to increase its staff to 85 employees by the end of 2021 to support the production of LVVs. The US is the CDMO’s main market, representing 70% of its customer base, with companies in Europe and Asia accounting for the remaining 30%.