Lentiviral vector manufacturing plant
San Sebastian, Basque Autonomous Community, Spain
VIVEbiotech, a good manufacturing practice (GMP) contract development and manufacturing organisation (CDMO) based in Spain, has opened a lentiviral vector manufacturing plant in Spain to meet demand from the cell and gene therapy industry.
The facility was inaugurated by officials of the Basque and Spanish governments in June 2021. The plant will be able to produce batches of lentiviral vectors ranging from those used for early-stage research to GMP vectors for clinical and future commercial applications.
The project is backed by the company’s partners and shareholders, including investment firm Easo Ventures and venture capital fund Inveready.
The facility will quadruple VIVEbiotech’s manufacturing capacity, with the average annual batch size set to increase from 20 in 2020 to 80 in 2022. The transition to the new facility is expected to be completed by October 2021.
Details of VIVEbiotech’s lentiviral vector manufacturing plant
The facility will be equipped with the largest bioreactor currently available in the market worldwide, and seven cleanrooms dedicated to lentiviral-vector production. It is part of VIVEbiotech’s capital investment plan to expand its capacity to 600m² of clean rooms, with eight nano bioreactors and two large-capacity bioreactors.
The production facility was built after the company secured the ‘Manufacturer of Investigational Medicinal Products’ status from the Spanish Agency of Medicines and Medical Products. The authorisation allows the company to produce drugs that can be administered in vivo to patients during clinical trials.
The plant’s modular design will provide the flexibility to add more clean rooms in future and support more batches. The initial expansion will increase the company’s product range and expand its product delivery for all stages of clinical trials and commercialisation.
The plant adheres to the regulatory requirements of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). It will allow the company to commercially manufacture its products to satisfy growing demand for lentiviral vectors, thereby contributing to the growth of the cell therapy sector.
The expansion will allow the company to increase the product offerings to its customers.
Other VIVEbiotech expansions
VIVEbiotech has also expanded its other main departments, including research and development (R&D) and upstream and downstream process development.
The R&D department aims to improve intrinsic lentivirus characteristics, while the upstream and downstream processes development departments are focused on enhancing the cost-effectiveness, scalability and regulatory compliance of the production process.
VIVEbiotech will increase its staff to 85 persons by the end of 2021 to support the production of lentiviral vectors.
Services offered by VIVEbiotech
VIVEbiotech provides a range of manufacturing-related services for the lentiviral vectors, including early-phase development specific to the needs of each vector, R&D production in bioreactors, GMP batches used in clinical and commercial phases, and stability studies.
The R&D department works on multiple projects that are applied to the services once the desired results are obtained in the R&D process.
The company operates process optimisation departments for both upstream manufacturing and downstream purification to deliver a highly functional product.
Marketing commentary on VIVEbiotech
VIVEbiotech is a lentiviral vector GMP CDMO that provides customised solutions to its clients. It was the first Spanish company to develop viral vectors for clinical trials of gene treatments, which allow for the elimination or modification of diseased cells’ properties.
The company is currently manufacturing lentiviral vectors for 16 gene therapy projects, six of which include chimeric antigen receptor T cells (CAR-Ts). It serves customers in the US, Europe, Israel and Australia among other regions.