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Biofabri

A Spain-based vaccines company within the Zendal Group, combining clinical development with large-scale vaccine manufacturing. It is best known for MTBVAC, a live attenuated tuberculosis vaccine candidate in Phase III evaluation.

Company Overview

Biofabri develops and manufactures vaccines for human use, with capabilities spanning process development, GMP manufacturing and clinical supply. The company operates as Zendal’s human vaccines arm and supports both proprietary programs and external manufacturing collaborations.

Headquarters and Global Presence

Biofabri is based in O Porriño (Galicia), Spain. Its manufacturing footprint has been positioned for international supply, with the site referenced in pandemic-era initiatives to reserve capacity for large-volume vaccine production.

Founding and History

Biofabri was established in 2008 with a focus on human vaccine R&D and manufacturing. During the COVID-19 period, it was involved in large-scale manufacturing initiatives, including work connected to Novavax’s COVID-19 vaccine supply chain for Europe and agreements associated with CEPI-backed capacity reservation.

Therapy Areas and Focus

Biofabri’s disclosed focus is vaccine development and manufacturing, with the most visible disease-area emphasis in:

Tuberculosis prevention (MTBVAC as the lead proprietary candidate)
Pandemic and infectious disease manufacturing support (through external manufacturing collaborations)

Technology Platforms and Modalities

Biofabri’s work centers on:

Live attenuated bacterial vaccine development (MTBVAC is a genetically attenuated Mycobacterium tuberculosis candidate)
Vaccine process development and GMP manufacturing (drug substance and drug product, clinical through commercial scale)
Tech transfer and scale-up for partner vaccine programs

Programs and Clinical Pipeline

MTBVAC (tuberculosis vaccine candidate)

Phase III: A head-to-head efficacy, safety and immunogenicity trial versus BCG in newborns in TB-endemic regions of sub-Saharan Africa (commonly referenced as the IMAGINE program; one registered trial is NCT04975178).
Earlier-stage work: Prior Phase I and Phase II studies have been completed and have supported progression into pivotal evaluation.

Key Personnel

Recent publicly reported leadership activity includes:

Rolando Pajón Feyt: appointed as Medical and Scientific Director (announced February 17, 2026) to support the late-stage clinical development phase of MTBVAC.

Strategic Partnerships

Biofabri has been named in several external-facing collaborations tied to manufacturing capacity and TB vaccine development:

CEPI: agreement (announced in 2020) to reserve vaccine manufacturing capacity for outbreak response.
TB vaccine ecosystem collaborations: MTBVAC development has been associated publicly with global TB stakeholders and trial partners (including large-scale clinical trial operators).
COVID-19 supply chain manufacturing: Biofabri was publicly linked to manufacturing work supporting the Novavax COVID-19 vaccine supply chain for the EU (historical, pandemic-era activity).

FAQ Section

Biofabri’s core activity is vaccine development and GMP manufacturing. On the R&D side, its most advanced proprietary program is MTBVAC, a live attenuated tuberculosis vaccine designed to improve protection versus BCG. Operationally, Biofabri also functions as a manufacturing partner for third-party vaccine programs where scale, quality systems and tech transfer capability are required.

Biofabri’s proprietary pipeline emphasis is tuberculosis prevention. Beyond its own pipeline, the company’s role in infectious diseases is largely manufacturing-led—supporting development and supply for external vaccine programs, including pandemic-response capacity initiatives.

The disclosed lead program is MTBVAC for tuberculosis prevention, currently in Phase III evaluation in newborns in TB-endemic settings. Public materials typically position MTBVAC as the company’s primary proprietary clinical asset.

Most recent items, in reverse chronological order:

February 17, 2026: Biofabri announced the appointment of Rolando Pajón Feyt as Medical and Scientific Director, framed as strengthening the final stage of MTBVAC’s clinical development.
2024–2025: MTBVAC Phase III activity continued under the IMAGINE clinical trial framework in sub-Saharan Africa, comparing MTBVAC with BCG in newborn populations.
2020 (pandemic-era): Biofabri was publicly named by CEPI as part of a manufacturing-capacity reservation initiative, and it was linked to manufacturing activities supporting Novavax’s COVID-19 vaccine supply chain for Europe.

Public-facing summaries describe MTBVAC as having progressed through Phase I and Phase II safety and immunogenicity studies, supporting advancement into Phase III efficacy evaluation versus BCG in newborns. The key decision-making dataset now is Phase III—whether MTBVAC demonstrates superior or at least clinically meaningful protective efficacy alongside an acceptable safety profile in the intended infant population.

For MTBVAC, the next milestones are typical of a pivotal vaccine program:

Phase III execution (enrollment completion, follow-up duration, and case accrual)
Top-line efficacy and safety readout, followed by regulatory strategy definition by geography (including manufacturing comparability and lot consistency planning for licensure)
Alignment on post-approval commitments and pharmacovigilance planning for infant immunization use, if the program reaches filing stage

Three practical indicators matter most:

MTBVAC Phase III progress: clarity on timelines, endpoint performance, and whether results support differentiation versus BCG
Late-stage readiness: manufacturing scale strategy, consistency plans and quality systems suitable for global supply
External manufacturing traction: whether Biofabri continues to be selected for high-volume vaccine manufacturing projects beyond MTBVAC, indicating sustained competitiveness as a European vaccine manufacturer

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