VIVEbiotech says its facility in San Sebastian is fully operational after it received renewal of its GMP accreditation for a further three years.
Contract development manufacturing organization (CDMO) VIVEbiotech claims the good manufacturing practice (GMP) accreditation means it is now certified for in vivo applications as well as ex vivo.
Additionally, the CDMO’s capabilities will continue to be expanded through the incorporation of automated processes. VIVEbiotech says that it is looking at automation as a potential solution to cost challenges highlighted as a barrier to access for cell and gene therapies.
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“In this new facility we are continuing to expand all the different areas from R&D to engineering to GMP manufacturing to be able to manufacture from early-stage to commercial-scale lentiviral vector batches. As a result, we have many intermediate scales accessible with wide slot availability,” Natalia Elizalde, business development director at VIVEbiotech told BioProcess Insider.
“Additionally, VIVEbiotech is incorporating automated processes in different areas. As an example, it should be noted that we have integrated an automated fill-finish system.”
The expansion of its San Sebastian plant has also increased the number of manufacturing slots available to product lentiviral vectors, according to the CDMO.
“VIVEbiotech offers slots in a very timely and convenient manner,” said Elizalde. “We can start set-up phases very promptly, avoiding any kind of delays. Once these set-up phases have been performed, engineering and GMP phases are executed consecutively. For us it is essential to customize every single set-up phase so that we can proceed with more advanced phases as soon as this initial crucial design is finished.”
As well as increasing the number of manufacturing slots, the firm has expanded its workforce by over 50 percent in the last two years, bringing the total number of employees to more than 100.
Elizalde said that VIVEbiotech has been fortunate in the recruitment process due to “agreements with highly specialized professional training centers and as a result, we are guaranteed the hiring of qualified personnel such as trained laboratory technicians. Regarding intermediate and key positions, we can say they are almost fully covered and VIVEbiotech now has a very well-structured organization chart.”
The CDMO has 40+ programs underway, four of which are dedicated to invivo administration, and the firm believes that in vivo technologies will enable VIVEbiotech to make use of lentiviral vectors as final products.
While VIVEbiotech is continually expanding its lentiviral vector manufacturing capabilities, Elizalde said “even if we have a very well-established manufacturing platform, we are continuously working to get more scalable and cost-effective processes.”
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