BIOFABRI

What BIOFABRI does

Biofabri, S.L. is a Spanish biopharmaceutical company founded in 2008 and headquartered in O Porriño, Pontevedra, Spain. The company operates as a wholly-owned subsidiary of the Zendal Group and specializes in the research, development, and manufacturing of human vaccines and immunotherapies, employing 101-250 people. Its core product is MTBVAC, the only live-attenuated Mycobacterium tuberculosis vaccine in clinical trials, offered in two formulations — MTBVAC PRIME for newborns and MTBVAC BOOSTER for adolescents and adults — designed to address limitations of the BCG vaccine which lacks over 100 genes compared to the human pathogen. The company also markets IMMUNO BCG, an immunotherapy for non-muscle invasive bladder cancer, and provides EU GMP certified CDMO services for biologics and vaccine contract development and manufacturing across preclinical to commercial stages.

Name

BIOFABRI

Legal name

Biofabri, S.L.

Website

https://biofabri.es

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

101–250 employees

Short description

Biofabri is a Spanish biopharmaceutical subsidiary of Zendal Group developing human vaccines, including MTBVAC (a live-attenuated tuberculosis vaccine in Phase 3 trials), the IMMUNO BCG bladder cancer immunotherapy, and EU GMP certified CDMO biologics manufacturing services.

Ownership category

akta.pro rank

Product category

Human Vaccines

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Vaccine Technology Platforms (mRNA, viral vector, protein subunit, inactivated/live-attenuated, VLP, DNA) (HLAAAEAD)

akta.pro secondary industries

Therapeutic Vaccines (cancer, chronic infection immunotherapy) (HLAAAEAB), Adult Vaccines (HLAIAEAB), Clinical Development & Regulatory for Vaccines (trials, pharmacovigilance, lot release) (HLAAAEAK), Immunization & Vaccine Delivery Programs (BPADAIAB)

Keywords

• Human vaccine development
• Biologics contract manufacturing
• Tuberculosis vaccine research
• Immunotherapy products
• Vaccine CDMO services

Headquarters

HQ city

Pontevedra

HQ country

Spain

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Technology or R&D, Supply Chain

Distribution channels3 records

Marketing channels4 records

Core offering

Biofabri researches, develops, and manufactures human vaccines and immunotherapy products. Its flagship asset is MTBVAC, a live-attenuated Mycobacterium tuberculosis vaccine in Phase 3 clinical trials, offered in neonatal (MTBVAC PRIME) and adolescent/adult (MTBVAC BOOSTER) formulations. The company also produces IMMUNO BCG, a BCG-based immunotherapy for non-muscle invasive bladder cancer, and provides EU GMP certified Contract Development and Manufacturing Organization (CDMO) services for third-party biologics and vaccines from development through commercial-scale production.

Product overview

Biofabri is a biopharmaceutical company founded in 2008 and part of the Zendal Group, specializing in human vaccines and immunotherapy. The company operates two core product lines: (1) MTBVAC - a novel live-attenuated tuberculosis vaccine with two formulations (MTBVAC PRIME for newborns and MTBVAC BOOSTER for adolescents/adults), representing the most advanced pipeline asset currently in Phase 3 clinical trials; and (2) IMMUNO BCG - an immunotherapy for non-muscle invasive bladder cancer. Biofabri also offers CDMO (Contract Development and Manufacturing Organization) services providing end-to-end biologics development and manufacturing capabilities from preclinical through commercial scale, EU GMP certified. The company utilizes multiple vaccine technology platforms including classic vaccines, genetically engineered live attenuated vaccines, subunit vaccines (recombinant protein), and latest-generation RNA and DNA vaccines.

Differentiator

Problem solved

Functional benefit

Products and services

• MTBVAC Live-attenuated Mycobacterium tuberculosis vaccine designed to provide improved efficacy compared to BCG; the only live-attenuated M. tuberculosis vaccine evaluated in clinical trials demonstrating safety, efficacy and immunogenicity in both preclinical and clinical studies.
• MTBVAC PRIME MTBVAC formulation for newborns, designed as a more effective and potentially longer-lasting alternative to BCG for neonatal immunization in TB-endemic regions.
• MTBVAC BOOSTER MTBVAC formulation for adolescents and adults, designed to prevent TB disease in populations for whom there is currently no effective vaccine.
• IMMUNO BCG Immunotherapy based on BCG to combat recurrence of non-muscle invasive bladder carcinoma (superficial bladder carcinoma), which originates in cells lining the inner surface of the bladder.
• CDMO Services Contract Development and Manufacturing Organization services for biologics and vaccines, from development phase through clinical phases I to III as well as commercial-scale manufacturing; EU GMP certified.

Quantifiable outcome

• Phase 3 trial enrolled with 7120 newborns across 6 sites in sub-Saharan Africa
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Ten partnerships are on record, tiered core and major.

• IAVIcoreStrategic or Co-development Partner · 1 June 2026Nonprofit scientific research organization developing vaccines and antibodies for HIV, TB, emerging infectious diseases, and neglected diseases. IAVI brings 15 clinical research centre partners in South Africa, Kenya, and Tanzania for Phase 2b IMAGINE clinical trial evaluating MTBVAC in adolescents and adults.
• TuBerculosis Vaccine Initiative (TBVI)coreStrategic or Co-development Partner · 1 June 2026Research and Innovation partnership that facilitates the discovery and development of new, safe and effective TB vaccines that are accessible and affordable for all people. Brings together partners from around the world creating an enabling environment for TB vaccine research and innovation.
• EDCTP (European & Developing Countries Clinical Trials Partnership)coreStrategic or Co-development Partner · 1 June 2026Public-public partnership between institutions mandated by national governments in Europe and sub-Saharan Africa, supported by the European Union. Awarded €18.2 million to MTBVAC AVANTE consortium for advancing clinical trials in sub-Saharan Africa.
• MTBVAC AVANTE Consortium PartnerscoreStrategic or Co-development Partner · 1 June 202612-partner consortium including: IAVI Stichting (Netherlands), IAVI South Africa, IAVI Africa (Kenya), Enhancing Care Foundation NPC (South Africa), Ifakara Health Institute (Tanzania), South African TB Vaccine Initiative (SATVI), Universidad de Zaragoza (Spain), University of Cape Town Lung Institute, Wits Health Consortium (South Africa), Kenya Medical Research Institute. Consortium advancing Phase 2b IMAGINE and Phase 3 MTBVACN3 clinical trials.
• Bharat Biotech International Limited (BBIL)coreStrategic or Co-development Partner · 22 December 2025Technology transfer agreement for MTBVAC tuberculosis vaccine to prepare BBIL for manufacturing readiness in India ahead of vaccine licensure. Follows a 2022 licensing deal. Partnership aims to support manufacturing and distribution in over 70 countries as part of India's Phase III clinical trial preparations expected to start recruiting in early 2026.
• CZ VaccinescoreTechnology or IntegrationPart of Zendal Group specializing in development and manufacturing of biological products and vaccines for human and animal health. Has 30 years of experience with EU GMP certification. Offers CDMO services for third-party companies with manufacturing facilities in Spain and Portugal.
• University of ZaragozacoreStrategic or Co-development PartnerMTBVAC was designed by Dr. Carlos Martín Montañés from the Department of Microbiology at University of Zaragoza in collaboration with Brigitte Gicquel from Institut Pasteur. University provides ongoing research collaboration in TB vaccine development.
• Institut PasteurcoreStrategic or Co-development PartnerPrivate nonprofit foundation with mission to help prevent and treat diseases, mainly those of infectious origin, through research, teaching, and public health initiatives. Co-designed MTBVAC vaccine with University of Zaragoza.
• Fundação Ataulpho de Paiva (FAP)majorStrategic or Co-development PartnerPartnership established to facilitate regional manufacturing capacity in Brazil for MTBVAC vaccine distribution.
• Zendal GroupcoreOthersBiofabri is part of Zendal, a Spanish biopharmaceutical group comprising seven companies focused on researching, developing, manufacturing and marketing high value-added products in the healthcare industry. Specializes in development and large-scale manufacturing of vaccines and other biologics.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Lonza: World's largest contract biologics manufacturer offering mammalian and microbial biologics production. Comparable to Biofabri's CDMO business as a large-scale GMP-certified contract manufacturer serving vaccine and biologics developers globally.
• Merck & Co. (MSD): Major vaccines and biologics manufacturer with late-stage infectious disease pipeline. Comparable to Biofabri as an established developer of complex biological products (including vaccines) with global commercial and manufacturing infrastructure.
• Serum Institute of India: World's largest vaccine manufacturer by doses, producing BCG and developing recombinant TB vaccine candidates (e.g., VPM1002). Comparable as a high-volume, low-cost global vaccine producer serving similar public-sector immunization markets as Biofabri targets.
• Sanofi Pasteur: Sanofi's vaccines division develops and commercializes a broad portfolio of human vaccines across bacterial and viral indications. Comparable as a global vaccine developer with EU/EMA-grade manufacturing, regulatory expertise, and global distribution reach overlapping with Biofabri's ambitions.
• GSK: Global vaccines giant developing the M72/AS01E tuberculosis vaccine candidate, the most advanced competing TB vaccine. Directly comparable as a major vaccine R&D and commercial manufacturer operating in infectious disease immunization at global scale.

Others

• TuBerculosis Vaccine Initiative (TBVI): Non-profit product development partnership advancing new TB vaccines, and a current Biofabri consortium partner. Comparable as an enabler and coordinator within the TB vaccine R&D ecosystem, shaping access pathways for candidates like MTBVAC.

Direct peers

• Catalent: Global biologics CDMO offering vaccine and viral vector development and manufacturing services from preclinical through commercial scale. Directly comparable to Biofabri's CDMO service line targeting third-party biologics manufacturers.
• IDT Biologika: German CDMO and vaccine developer offering contract manufacturing for human and veterinary vaccines, including biologics fill-finish. Comparable to Biofabri as a mid-sized European CDMO with vaccine platform capabilities and EU GMP certification.
• Bharat Biotech International: India-based vaccine manufacturer and Biofabri's technology transfer and licensing partner for MTBVAC. Operates in human vaccine R&D and manufacturing across viral and bacterial diseases with WHO prequalified products, making it a directly comparable vaccine developer and manufacturer.

Emerging players

• Vakzine Projekt Management: German biotech developing VPM1002, a recombinant BCG vaccine candidate for tuberculosis. Directly comparable to Biofabri as a small specialized TB vaccine developer focused on improving on standard BCG.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInes.linkedin.com/company/biofabri

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BIOFABRI