The expansion of VIVEbiotech facilities will enable increased production capacity and the further optimization of its manufacturing processes. Versatility in the design will result in a more flexible configuration enabling the possibility of further clean rooms in the future as well as making it feasible accommodating a much larger number of batches.
In addition, the expansion will provide the additional space for VIVEbiotech to invest in additional manufacturing capital and equipment to be able to respond to the different phases of upcoming projects. This will also cater for the international market requirement for an increase in sophistication of lentiviral manufacturing, with a combination of flexibility, cost-effectiveness and an increase in efficiency.
“The continued expansion of the gene and cell therapy sector has resulted in an increase in the number of clinical trials, as well as additional trials moving into later-stage development. In turn, this has led to a continued increase in the demand for both lentiviral vectors, as well as expertise in their use and application,” said Gurutz Linazasoro, CEO of VIVEbiotech. “This demand for lentivirals is increasing for therapies throughout the clinical stages and into commercialization. A higher number of early-stage cell and gene therapy developers now are requiring a longer-term partner in lentiviral supply that provides continuity throughout the clinical stages. VIVEbiotech has responded to this growth in requirement from the cell and gene therapy sector by constructing new facilities with increased cleanrooms to cater for the demand, and a renewed focus on innovation to continue leading the development of lentiviral vectors. This will enable us to utilize our sole lentiviral expertise and specialization to contribute towards moving gene therapies through the clinical process and to patients in a range of different conditions.”
The new facilities will also provide the potential for VIVEbiotech to further advance the optimization of lentiviral-vector properties and the associated manufacturing process. Therefore, VIVEbiotech has a highly qualified team specialized both in manufacturing and in virology. This is required as the international gene and cell therapy sectors move into a broader spread of indications that affect more patients and use more innovative applications.
The new facilities are expected to be completed in April 2021, and VIVEbiotech aims for the transition between the facilities to be completed in October.