skills
We foster collaborative and trust-based business environments, aimed at building an economy focused on the development and use of talent in Biomedicine, with a special focus on advanced therapies.
skills
We foster collaborative and trust-based business environments, aimed at building an economy focused on the development and use of talent in Biomedicine, with a special focus on advanced therapies.
This is a pharmaceutical lab created by Leitat Medical, which follows Good Manufacturing Practices (GMP) standards for the manufacture and marketing of gene therapy elements:
Founded in 2021, Gene Vector Barcelona is a small company (SME) that started out as a Special Purpose Company (SPC) to comply with all the regulatory and legal requirements set by the Spanish Medicines Agency (AEMPS) and the European Medicines Agency (EMA) to manufacture and export viral vectors used to produce gene therapies.
The first products manufactured by Gene Vector were the lentiviral vectors used to produce the 2nd generation CAR-T therapies developed at Hospital Clínic de Barcelona, currently ARI-0001 and ARI-0002.
Gene Vector has also participated in the following projects:
Implementation of scaled and centralized production of viral vectors for the manufacture of varnimcabtagene autoleucel (var-cel) for commercial development and international expansion. (2023 – 2024).
Joint action ISCIII-CDTI, innovation in personalized medicine (PMTA22/00093 / IDI-20230060). Coordinated project: Gene Vector Barcelona, S.L., Fundació de Recerca Clínic Barcelona – Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS).
Project PMPTA22/00093 / IDI-20230060 funded by the Recovery, Transformation and Resilience Plan financed by the European Union – NextGenerationEU.
Optimised platform for the personalised production of transgenic TCR in T lymphocytes (2023 – 2025).
Joint action ISCIII-CDTI, innovation in personalized medicine and advanced therapies (PMTA23/00027 / IDI-20230956). Coordinated project: Gene Vector Barcelona, S.L., Fundació de Recerca Clínic Barcelona – Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS).
Project PMTA23/00027 / IDI-20230956 funded by the Recovery, Transformation and Resilience Plan financed by the European Union – NextGenerationEU.
Innovative Human-Derived 3D Liver Models for Drug Toxicity Testing and Discovery (2022 – 2025).
Projects in public-private collaboration 2021 (CPP2021-008633). Coordinated project: ReadyCell (Coordinator), Leitat (Technical Coordinator), Vall d’Hebron University Hospital – Vall d ‘Hebron Research Institute (HUVH-VHIR).
Project CPP2021-008633 funded by the Ministry of Science and Innovation – State Research Agency, MICINN-AEI/10.13039/501100011033 and the European Union – NextGenerationEU/PRTR.
Microphysiological systems based on liver on chip for drug discovery and testing (2022 – 2025).
R&D projects in strategic lines 2022 (PLEC2022-009481). Coordinated project: Leitat (Coordinator), Vall d ‘Hebron-Vall d ‘HebronUniversity Hospital Research Institute (HUVH-VHIR), ReadyCell.
Project PLEC2022-009481 funded by the Ministry of Science and Innovation – State Research Agency, MICINN-AEI/10.13039/501100011033 and the European Union – NextGenerationEU/PRTR.
Optimization in the production of lentiviral vectors for the production of CAR-T therapies or other cell therapies (LENTI-UP) (2023 – 2024).
Complementary Biotechnology Plan applied to Health (C17.I1), Recovery, Transformation and Resilience Plan (PRTR-C17.I1) (ID Z7318). Coordinated project: Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS) (Coordinator), Leitat, Hospital Sant Joan de Deu (HSJD); Collaborator: Complejo Hospitalario Universitario de Santiago (CHUS)-Galaria.
Project co-financed by the Ministry of Science and Innovation with funds from the European Union NextGenerationEU, of the Recovery, Transformation and Resilience Plan (PRTR-C17.I1) and the Autonomous Community of Catalonia within the framework of the Complementary Plan for Biotechnology Applied to Health.
Development of a novel lentiviral Production Cell System for optimized Gene Therapy manufacturing. (2023 – 2026).
Projects in Public-Private Collaboration 2022 (PCPP2022-009650). Coordinated project: Gene Vector (Coordinator), Leitat.
Project PCPP2022-009650 funded by the Ministry of Science and Innovation – State Research Agency, MICINN-AEI/10.
13039/501100011033 and the European Union-NextGenerationEU/PRTR.
State Network Consortium for the Development of Advanced Therapy Medicinal Products (CERTERA).
This call, which is part of the actions of the PERTE for Vanguard Health, granted 45 million euros to 43 entities in 14 autonomous communities via the Ministry of Science and Innovation, through the Carlos III Health Institute (ISCIII), thanks to European funds from the Recovery, Transformation and Resilience Plan.
The CERTERA Consortium is a networked scientific and technical R+D infrastructure aimed at the development of advanced therapy drugs from academic environments to early clinical trials, always in pre-commercial phases. To this end, it gathers, coordinates and amplifies the already existing or under-construction capacities in this area in Spain. The CERTERA structure will also facilitate the establishment of strategic alliances with the industrial sector.
Leitat is the largest Spanish beneficiary in the call, being granted a total budget that exceeds 10 million euros.
It’s a unique proposal that encompasses a comprehensive vision and outstanding training at the national level.
A phase 2, European multinational, single-arm clinical trial to evaluate the efficacy and safety of varnimcabtagen autoleucel for the treatment of acute lymphoblastic leukemia in relapsed/refractory adults. ATTRACT 2023 Call.
Coordinated Project: Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS) (Coordinator).
Gene Vector participates as a centralized producer and distributor of the ARI-0001 lentiviruses for this European multinational CAR19-BE-04 Phase 2 trial that has obtained European funding (ATTRACT 2023 Call, funded with €9.3M) that will be opened in 4 countries in addition to Spain, which are the Netherlands, Belgium, France and Austria.
Dr Sílvia Cufí is a biologist and holds an International PhD in Biomedicine from the University of Girona and the Salk Institute in the United States. She has more than fifteen years of experience in biomedical research, innovation and healthcare technology transfer.
She holds several master’s degrees in biomedicine, a postgraduate qualification in healthcare management and an Executive Development Programme (PDD) in research, innovation and technology transfer institutions from IESE Business School.
Previously, she was Corporate Director at the TIC Salut Social Foundation, part of the Department of Health of the Government of Catalonia, where she led initiatives in digital transformation, omics data and digital health. She has also held strategic innovation and technology transfer roles at the Barcelona Clínic Campus.
She is an Associate Professor at the University of Girona and the author of more than sixty scientific articles, with an h-index of 23. Her research has focused on cancer, metabolism, stem cells and autophagy. She also serves as an expert project evaluator for organisations including the Carlos III Health Institute, the European Commission and the ”la Caixa” Foundation.
She currently works at Leitat, with a particular focus on Advanced Therapy Medicinal Products (ATMPs), leading initiatives in biomedicine, advanced medicinal product development and technology transfer. At Leitat, she is the Principal Investigator of the Spanish CERTERA consortium, funded by the Carlos III Health Institute, and promotes public-private partnerships, high-impact projects and multidisciplinary teams. Leitat also has GMP manufacturing and cleanroom capabilities through GeneVector Barcelona, an AEMPS-accredited CDMO.
