Draft:VIVEbiotech

• Comment: In accordance with Wikipedia's Conflict of interest policy, I disclose that I have a conflict of interest regarding the subject of this article. Mikeletegui (talk) 07:14, 29 July 2025 (UTC)

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VIVEbiotech is an international biotechnology company based in Donostia-San Sebastian, Basque Country, Spain. It is the first and only Spanish CDMO GMP specialized exclusively in the development and manufacture of lentiviral vectors (LVV) for advanced therapies aimed at fighting diseases such as hematological cancer (leukemias, lymphomas, myelomas...), solid tumors and rare hematological, metabolic or primary immunodeficiency diseases, among others. It currently has more than 45 clients, being present in more than 15 countries on four continents. Nearly 50% of its activity is concentrated in the United States, although it also maintains a solid presence in Europe -especially in Belgium, Germany, the Netherlands and Switzerland- and has begun to expand into Asia and Australia.

History The background of VIVEbiotech goes back to the Inbiomed Foundation, a regenerative medicine research centre founded in 1997. The creation of the company -initially incorporated as Inbiomed Pharma S.L.- was driven by the team of professionals at Inbiomed, among them the neurologist Gurutz Linazasoro. The new company was created with the aim of channelling, from a business perspective, the knowledge and experience accumulated in the field of cell therapies and gene therapies.

2015-2017 In 2015, and thanks to all the knowledge accumulated in the Inbiomed Foundation, VIVEbiotech was born, in Donostia-San Sebastian. During this first stage, the company began to develop lentiviral vectors for gene therapy in the Miramon Technology Park, giving rise to the first production facilities and becoming accredited in compliance with GMP in 2017 before the Spanish Agency of Medicines and Health Products (AEMPS).

2017-2019 After its accreditation, VIVEbiotech started with the production and commercialization of viral vectors for cell and gene therapy. Since then, the company has continued to grow, increasing its production and its worldwide customer base to more than 45 customers today.

2019-2021 During this stage, significant investments were made as the first phase of the production capacity expansion process is to be implemented in 2021. In addition, the planning of the construction and assembly of the new manufacturing plant was carried out.

2021-2024 In February 2021, VIVEbiotech received authorization as a Pharmaceutical Laboratory, which gave it the capacity to manufacture lentiviral vector-based drugs for in vivo use. In August of the same year, the new facilities in the Tandem Building were inaugurated and the renewal of the GMP certification by the AEMPS was obtained. In December 2024, the US Ampersand Fund made an important investment aimed at consolidating VIVEbiotech as a reference CDMO in the manufacture of lentiviral vectors.

Current and future plans VIVEbiotech currently has seven clean rooms in a manufacturing facility of more than 3,000 m² and a team of more than 140 employees. The company continues to work on the development of larger production scales and is in the advanced stages of reaching commercial scale. As part of this growth strategy, it plans to build a new plant that will significantly expand its operating capacity.

Operations VIVEbiotech develops and manufactures lentiviral vectors, being European leaders and working under the regulations of the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). Lentiviral vectors produced by VIVEbiotech are administered by their clients both ex vivo and in vivo to treat various disorders, such as hematological and solid cancers and rare diseases.

In summary, the highlights of VIVEbiotech are as follows: 

- VIVEbiotech is a biotech company that develops and produces lentiviral vectors for gene therapy clinical trials. - It is a leading GMP-certified CDMO, a Development and Manufacturing Organization with a service tailored to the needs of its customers. - It covers all processes, from innovation to production for clinical trials, with large-scale commercial capabilities. - The company produces according to GMP regulations and follows EMA and FDA standards.

Lentivirus A lentivirus is a type of retrovirus that causes chronic diseases characterized by long incubation periods. Taking advantage of certain properties of lentiviruses, biotechnologists have developed in recent decades what we now call lentiviral vectors, which allow the genetic modification of patients' cells with therapeutic genes.

The most relevant properties of lentiviral vectors as a gene engineering tool are: - Their high transduction efficiency: this means that, compared to other gene therapy vectors, the number of particles to be applied to obtain the therapeutic effect is very small, which facilitates the process. - Its ability to transduce many different cell types regardless of whether the cell divides or not. This allows it to be the most widely used vector for CAR-T immunotherapies that save the lives of numerous hematological cancer patients. - Its ability to permanently modify cells: this allows effective therapies with a single dose. - Its ability to display on its surface envelope proteins different from those carried by the original lentivirus (pseudotype), which allows it to target all or certain specific cells.