VIVEbiotech, a gene transfer technologies Contract Development and Manufacturing Organization (CDMO) developing and GMP manufacturing lentiviral vectors, today announces it is opening new facilities for the manufacture of lentiviral vectors for the cell and gene therapy sector The facility will be capable of manufacturing batches ranging from those for early stage research to GMP for clinical and future commercial uses.
The facilities will be opened in a ceremony held on June 4, 2021 by by Iñigo Urkullu, the president of the Basque Government in Spain. Pedro Duque, Minister of Science and Innovation of the Spanish government will also participate.
The expanded facilities will allow VIVEbiotech to significantly increase its production capacity and deliver commercial-size batches of lentiviral vectors to both new and existing customers across the cell and gene therapy industry. VIVEbiotech’s production capacity will increase by 400%, with an increase in average batch size per year from 20 in 2020 to 80 in 2022. VIVEbiotech will also be able to broaden its product portfolio, and scale its delivery of products for all phases of clinical trial and commercialization.
VIVEbiotech will also install within the new facilities the largest bioreactor currently available on the global market, and seven cleanrooms fully specifically set up for lentiviral-vector manufacturing. 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.
VIVEbiotech has expanded its manufacturing facilities alongside its other key departments in the organisation. These include its R&D, upstream and downstream process development departments. The R&D department focuses on enhancing intrinsic lentivirus characteristics, while both process development departments are dedicated to making the manufacturing process more cost-effective, scalable and regulatory compliant. As a result of the expansion, VIVEbiotech will also meet the rising demand for lentiviral vectors through expanding its workforce to 85 employees by the end of 2021.
The manufacturing facilities have been constructed following the Spanish Agency of Medicines and Medical Products granting VIVEbiotech ‘Manufacturer of investigational Medicinal Products’ authorization. This authorizes VIVEbiotech to manufacture drugs that will be administered in vivo in clinical trials. This authorization is an addition to VIVEbiotech’s “Manufacturer of sterile or biological active substances” status, enabling VIVEbiotech to manufacture intermediate products. VIVEbiotech is currently working in accordance with both EMA 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 to will enable the commercial scale production of our products,” said Gurutz Linazasoro, CEO, VIVEbiotech. “VIVEbiotech are one of the few companies that have fully specialized 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, which currently stands at over 20 global organisations and 35 international projects.”
VIVEbiotech aims for the transition between the facilities to be completed in October.
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. Working with European, US-based and Asian companies, 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 and the enhancement of the safety profile of viral vectors. In this setting, VIVEbiotech has its own worldwide licensed technology, LENTISOMA. For more information, visit https://www.vivebiotech.com/