VIVEbiotech continues the expansion of its lentiviral vector manufacturing capabilities to address the viral vector bottleneck

San Sebastián, Spain, June 21, 2022 - VIVEbiotech, S.L., a gene transfer technologies Contract Development and Manufacturing Organization (CDMO) developing and GMP manufacturing lentiviral vectors, today announces its Good Manufacturing Practice (GMP)-accredited new facility is now fully operational after receiving the renewal of its GMP accreditation for a further three years.

“As the cell and gene therapy industry continues to grow, we are seeing an exponential increase in the demand for lentiviral vectors. Our facility now being fully operational puts us in the best position to support our customers, from those in early-stage clinical development up to commercialisation,” said Gurutz Linazasoro, CEO, VIVEbiotech. “VIVEbiotech is one of the few companies to be solely focused on the manufacture and development of lentiviral vectors. Furthermore, our expertise in virology allows us to support our customers throughout the development cycle, maximizing production and thus guaranteeing success in more advanced phases. The advanced medicines field has been experiencing a viral vector bottleneck, as the supply is struggling to keep up with demand. We are now ideally placed to help the industry address this bottleneck, and ultimately provide more patients access to these life-saving treatments.”

VIVEbiotech’s expansion has increased the number of manufacturing slots available to produce lentiviral vectors, in order to support customers throughout the development cycle. The Company’s workforce has expanded by over 50 percent in the last two years and now sits at over 100 employees dedicated to the development and manufacturing of lentiviral vectors. Through the expansion of their production capabilities and workforce, VIVEbiotech will be able to meet the industry’s rising demand for viral vectors.

A key aspect of VIVEbiotech’s new capabilities is the further incorporation of automated processes. Costs have been highlighted as a significant barrier to access for cell and gene therapies, and automation is increasingly being looked at as a solution to this issue. VIVEbiotech is able to simplify and quicken the final step by integrating an automated fill/finish system for delivery of their products. This demonstrates VIVEbiotech’s commitment to the digitalization of their entire plant and processes, contributing to the cost-effectiveness of their products.

Moreover, VIVEbiotech´s new GMP accreditation has a greater scope than its previous one. They are now GMP certified for in-vivo applications in addition to ex-vivo. The company currently has 40 programs ongoing, with four of them dedicated to in-vivo administration. In-vivo technologies will allow VIVEbiotech to use lentiviral vectors as a final product, and administer them directly to patients.

About VIVEbiotech S.L.

VIVEbiotech is a company fully specialized in lentiviral vectors with expertise as a GMP CDMO focused on the manufacture of lentiviral vectors from early stages to GMP. Created in 2015, VIVEbiotech works with companies based in Europe, US, Australia and Asia, and its main aim is to adapt to customer own requirements from a technical and timeline perspective. In addition, VIVEbiotech´s technology development strategy is focused on providing a response to the main hurdles that currently exist within the gene therapy field, mainly the need of cost-effective processes. For more information about publicly disclosed customers or any other general queries, visit https://www.vivebiotech.com/