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VIVEbiotech has opened its new lentiviral vector manufacturing facilities in Spain, expanding capacity for lentiviral vectors for use in cell and gene therapies.
VIVEbiotech, a gene transfer technologies contract development and manufacturing organization (CDMO) specializing in lentiviral vectors, announced on June 4, 2021 that it has opened new facilities in Spain for the manufacture of lentiviral vectors for the cell and gene therapy sector.
This expansion will allow the company to significantly increase its production capacity by 400% and deliver commercial-size batches of lentiviral vectors. The expansion also translates to an increase in average batch size per year from 20 batches in 2020 to 80 batches in 2022 of vector material. Furthermore, the facilities are capable of supplying material for early stage research as well as for good manufacturing practice (GMP) clinical- and commercial-scale quantities.
VIVEbiotech also plans to install the largest bioreactor currently available on the global market within the new facilities and seven cleanrooms specifically set up for lentiviral-vector manufacturing, the company stated in a press release. VIVEbiotech said it is using a flexible design that will allow it to further add more cleanrooms in the future as well as accommodate a larger number of batches.
The construction of these new facilities follows an authorization granted by the Spanish Agency of Medicines and Medical Products that allows VIVEbiotech to manufacture drugs to be administered in vivo in clinical trials. VIVEbiotech has also been authorized to manufacture intermediate products. The company currently works in accordance with European Medicines Agency and FDA regulatory requirements.
“The continued expansion of the gene and cell therapy sector has resulted in a significant increase in the demand for lentiviral vectors. In order to meet the exponential growth of lentiviral demand to support the growth of the wider cell therapy industry, VIVEbiotech has invested in new, state-of-the-art, manufacturing facilities [that] will enable the commercial-scale production of our products,” said Gurutz Linazasoro, CEO, VIVEbiotech, in the press release.
“VIVEbiotech [is] one of the few companies that have fully specialized [capabilities] in the manufacture of lentiviral vectors, with expertise in all phases of development, from drug discovery to commercial scale-manufacturing. The new facilities will enable VIVEbiotech to develop new projects and increase our offering to our growing customer base,” Linazasoro added in the press release.