GMP Manufacturing

Archivel Farma it the developer and manufacturer of the Proprietary RUTI® Vaccine

RUTI® is manufactured from a highly specialized drug substance consisting of purified and inactivated nano-cell wall fragments of Mycobacterium tuberculosis, produced in a dedicated Biosafety Level 3 (BSL-3) facility. The manufacturing process has been successfully scaled to industrial production, with each drug substance batch capable of supplying up to 80,000 vaccine vials.

Archivel Farma has established a strong and proven manufacturing track record, having produced more than 90 drug substance batches, over 30 preclinical batches, and 8 GMP clinical batches. This extensive experience demonstrates the robustness, scalability, and reliability of the manufacturing platform, providing a solid foundation to support late-stage clinical development and future commercialization.

GMP Manufacturing

Archivel Farma it the developer and manufacturer of the Proprietary RUTI® Vaccine

RUTI® is manufactured from a highly specialized drug substance consisting of purified and inactivated nano-cell wall fragments of Mycobacterium tuberculosis, produced in a dedicated Biosafety Level 3 (BSL-3) facility. The manufacturing process has been successfully scaled to industrial production, with each drug substance batch capable of supplying up to 80,000 vaccine vials.

Archivel Farma has established a strong and proven manufacturing track record, having produced more than 90 drug substance batches, over 30 preclinical batches, and 8 GMP clinical batches. This extensive experience demonstrates the robustness, scalability, and reliability of the manufacturing platform, providing a solid foundation to support late-stage clinical development and future commercialization.

archivelfarma-ruti

Bladder Cancer

Archivel Farma is a R&D biotech company that develops RUTI® as immunotherapeutic agent.

Bladder Cancer

Archivel Farma is a R&D biotech company that develops RUTI® as immunotherapeutic agent.

Bladder cancer is one of the most common cancers in men and represents a significant healthcare challenge worldwide. Approximately 70–80% of newly diagnosed cases are classified as non–muscle-invasive bladder cancer (NMIBC), a form of the disease characterized by high recurrence rates despite available treatments.

Since the 1980s, Bacillus Calmette-Guérin (BCG) therapy has been the standard treatment for NMIBC. Administered directly into the bladder, BCG helps reduce the risk of tumor recurrence and progression. However, treatment is associated with adverse effects and there remains a need for more effective and better-tolerated therapeutic options.

In collaboration with IrsiCaixa and IGTP, Archivel Farma is developing RUTI® as a novel immunotherapy for non–muscle-invasive bladder cancer (NMIBC). RUTI® has the potential to enhance the efficacy of standard BCG treatment through aninnovative prime-boost strategy and is also being explored as a future alternative to intravesical BCG therapy.

The Phase I RUTIVAC-1 clinical trial has been successfully completed and published, supporting the further clinical development of RUTI® in bladder cancer.

archvielfarma-ruti-bladder-cancer-1
Reference: Buisan O, Servian P, Pedreño-Lopez S, et al. A Novel Heterologous Prime-Boost Strategy Using RUTI® Vaccine to Improve the Bacillus Calmette-Guérin Response in Non–muscle-invasive Bladder Cancer Patients: Phase 1 RUTIVAC-1 Trial. Eur Urol. 2026;89:114–120.
“Our findings indicate that the new therapeutic strategy of RUTI® vaccination prior to intravesical BCG treatment in NMIBC patients is safe and capable of modulating the BCG-induced immune response by generating a more balanced effective/suppressive response, which ultimately improves patient outcomes. Despite the limited sample size and baseline imbalances limitations, this new approach has the potential to significantly impact both the clinical management of NMIBC patients and the consequent cost associated with high-risk NMIBC”

Tuberculosis

Archivel Farma is a R&D biotech company that develops RUTI® vaccine against Tuberculosis.

Tuberculosis (TB) continues to be one of the world’s deadliest infectious diseases, affecting an estimated 10.7 million people and causing more than 1.2 million deaths in 2024. Although antibiotic therapy can cure most patients, treatment remains lengthy and challenging, particularly in drug-resistant TB. These limitations have driven the development of therapeutic vaccines, a novel approach designed to work alongside standard antibiotic treatment by stimulating the patient’s immune system to better control and eliminate residual infection.

In collaboration with the Germans Trias i Pujol Research Institute (IGTP) and the Germans Trias i Pujol University Hospital,  Archivel Farma has developed RUTI®, a poly-antigenic vaccine aimed at the treatment of active, multidrug-resistant and latent tuberculosis since 2005.

RUTI® is an innovative immunotherapeutic vaccine originally developed by Archivel Farma to improve the treatment of tuberculosis (TB). Designed as an adjunct to antibiotic therapy, RUTI® aims to enhance the patient’s immune response against Mycobacterium tuberculosis, helping to reduce the residual bacterial burden, shorten the duration of treatment and potentially lower the risk of relapse.

The vaccine is based on inactivated cell-wall nanofragments of M. tuberculosis containing a broad spectrum of antigens, capable of inducing a strong polyantigenic immune response.

RUTI® was initially developed to prevent the progression of latent tuberculosis infection (LTBI) to active pulmonary TB. In Phase I and Phase II clinical studies, the vaccine demonstrated a favourable safety and tolerability profile, together with the ability to induce specific immune responses in a dose-dependent manner.

In 2016, the development strategy was redirected towards the use of RUTI® as a therapeutic vaccine administered alongside anti-tuberculosis treatment. The objective was to enhance treatment outcomes and potentially shorten or simplify antibiotic regimens, particularly in patients with drug-resistant TB. RUTI® has subsequently been evaluated in a Phase IIa study in Ukraine and in Phase IIb proof-of-concept clinical trials conducted in Argentina and India.

At present, the tuberculosis development programme is on hold pending a comprehensive assessment of the clinical data generated to date and the definition of the most appropriate strategy for future development.

Tuberculosis

Archivel Farma is a R&D biotech company that develops RUTI® vaccine against Tuberculosis.

Tuberculosis (TB) continues to be one of the world’s deadliest infectious diseases, affecting an estimated 10.7 million people and causing more than 1.2 million deaths in 2024. Although antibiotic therapy can cure most patients, treatment remains lengthy and challenging, particularly in drug-resistant TB. These limitations have driven the development of therapeutic vaccines, a novel approach designed to work alongside standard antibiotic treatment by stimulating the patient’s immune system to better control and eliminate residual infection.

In collaboration with the Germans Trias i Pujol Research Institute (IGTP) and the Germans Trias i Pujol University Hospital,  Archivel Farma has developed RUTI®, a poly-antigenic vaccine aimed at the treatment of active, multidrug-resistant and latent tuberculosis since 2005.

RUTI® is an innovative immunotherapeutic vaccine originally developed by Archivel Farma to improve the treatment of tuberculosis (TB). Designed as an adjunct to antibiotic therapy, RUTI® aims to enhance the patient’s immune response against Mycobacterium tuberculosis, helping to reduce the residual bacterial burden, shorten the duration of treatment and potentially lower the risk of relapse.

The vaccine is based on inactivated cell-wall nanofragments of M. tuberculosis containing a broad spectrum of antigens, capable of inducing a strong polyantigenic immune response.

RUTI® was initially developed to prevent the progression of latent tuberculosis infection (LTBI) to active pulmonary TB. In Phase I and Phase II clinical studies, the vaccine demonstrated a favourable safety and tolerability profile, together with the ability to induce specific immune responses in a dose-dependent manner.

In 2016, the development strategy was redirected towards the use of RUTI® as a therapeutic vaccine administered alongside anti-tuberculosis treatment. The objective was to enhance treatment outcomes and potentially shorten or simplify antibiotic regimens, particularly in patients with drug-resistant TB. RUTI® has subsequently been evaluated in a Phase IIa study in Ukraine and in Phase IIb proof-of-concept clinical trials conducted in Argentina and India.

At present, the tuberculosis development programme is on hold pending a comprehensive assessment of the clinical data generated to date and the definition of the most appropriate strategy for future development.

archvielfarma-ruti-tuberculosis-2

Ruti® on the media

TV3, QuèQuiCom –2016

TV3, Trenta Minuts –2011

Scientific Advisor

Dr. Pere-Joan Cardona

Institute for Health Science Research Germans Trias i Pujol (IGTP)

BIO

Doctor specialized in Clinical Microbiology and MD by the Autonomous University of Barcelona (UAB), he is the chief of the Experimental Tuberculosis Unity of the Germans Trias i Pujol Institute (IGTP). He also is associated teacher of the Genetics and Microbiology Department of the UAB from 2001. After his training at the Colorado State University (1995-96), he devoted to the study of tuberculosis in its more immuno-pathological side through “in vitro”, “in vivo” and “in silico” experimental models using human origin tissues. He is the Head of clinical microbiology Dept. Hospital Trial I Pujol from 2021. Reviser of several international specialized magazines, he is editor of the book “Understanding Tuberculosis”; he is author of 5 book chapters and of 70 articles revised by experts (index h=21). He is also Academic Editor of the PLOS One magazine since 2009.

He has been the Scientific and Medical Director of Archivel Farma during the Phase I and Phase II clinical trials of the RUTI® vaccine. He is author of the 7 invention patents referred to the RUTI® vaccine.

Collaborations

Dr. Pere-Joan Cardona and  Dr. Cristina Vilaplana Unitat Tuberculosis Experimental (UTE)
Prof. T. Van der Werf and M. Groeschel
Prof. Helen Fletcher and Satria Prabowo, PhD
Dr. Simon Clark
Prof. T. Van der Werf and M. Groeschel
Dr. Pere-Joan Cardona and  Dr. Cristina Vilaplana Unitat Tuberculosis Experimental (UTE)
Prof. Helen Fletcher and Satria Prabowo, PhD
Dr. Simon Clark

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