Valbiotis’ R&D centers

R&D Centers

Valbiotis has created a proprietary platform for its product development: Valbiotis R&D. This integrated Research and Development platform has been specifically designed for research on plants and applications in the field of metabolic and cardiovascular diseases. This cross-disciplinary entity brings together expert teams and infrastructures dedicated to plant-based chemistry, preclinical research on metabolism, and clinical development. It manages its entire product development chain from the discovery of active substances to the launch of clinical trials on humans, and complies with the highest quality standards, which contributed to Valbiotis achieving ISO 9001 certification.

Valbiotis R&D was designed to increase the creation of value over the long-term and to ensure the sustainable autonomy of the company.

Key figures

Team: 75% of the workforce at Valbiotis is assigned to Research and Development
Patents: 3 patent families filed by Valbiotis since 2014
Infrastructures: 2,600 m², of which 1,200 m² are dedicated to Discovery and Preclinical Research
Publications: 44 papers selected by international scientific and medical congresses since June 2016, and 10 scientific papers published by international journals since 2021.

R&D centers

+ a subsidiary in Quebec at Nutrition and Functional Food Institute (INAF) from Laval University.

A center of expertise for plant-based chemistry

In partnership with La Rochelle University and the CNRS, the La Rochelle center conducts research and analysis to develop and perfect active substances. This work is performed by teams specialized in plant-based chemistry and biotechnologies.

The center for plant-based chemistry focuses on:
• In collaboration with CMOs, the development of extraction processes for raw plant materials and the complete characterization of the extracts obtained (identification of biomolecules, in particular);
• Perfecting plant combinations;
• Purification and pharmacomodulation of biomolecules and certain plant extracts using the latest bioengineering techniques;
• Analytical support for the development of products, thanks to specific analytical methods, based on recognized standards, such as the European and American pharmacopeias.

A platform designed for Discovery and Preclinical Research in the field of metabolic and cardiovascular diseases

The Discovery and Preclinical Research platform is responsible for evaluating the potential of active substances and for conducting all the preclinical studies required to launch clinical studies on humans.

Located in Riom, France, this 1,200 m² cutting-edge scientific center has:
• A large in vivo screening capacity for metabolic disease models;
• The latest in equipment and methods, designed for studies on the metabolism of living beings at all levels.

As specialists in the study of metabolism, the research teams conduct all in vitro and in vivo investigations to generate data on a large scale relating both to the efficacy of Valbiotis’s products and to their modes of action.

Specific techniques for studying metabolism, on all biological levels:

• In vivo models – Diabetes, NAFLD, obesity, hypertension, dyslipidemia;
• Cell culture;
• Biochemistry – Enzymatic testing, plasmatic dosages, ELISA;
• Molecular biology – mRNA extraction/RT-qPCR, ELISA, western blot, etc;
• Physiology – microsurgery, euglycemic-hyperinsulinemic clamp, physiological monitoring by telemetry;
• Histology – staining, immunohistochemistry, fluorescence;
• Body composition by EchoMRI;
• Indirect calorimetry;
• Mitochondrial respiration;
• In vivo radiolabeling.

The clinical development center: compliance with the highest standards to reduce the risk of metabolic and cardiovascular diseases

Once validated in the preclinical phase, each product is subject to clinical trials to demonstrate its safety, tolerance and efficacy in target populations.
Development plans are drafted and supervised by the clinical research center based in Périgny.
The clinical studies are designed with experts and clinicians in the relevant field, and are conducted by CROs (contract research organizations) in collaboration with university hospitals in France and abroad (Europe, the United States and Canada). Each study complies with Good Clinical Practices (GCP) and ICH standards*.

*International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

 

Rigorous clinical studies

• Phase I/II: evaluation of product safety and tolerance; proof of concept regarding efficacy (15 to 40 subjects);
• Phase II: proof of product efficacy for one or more metabolic and cardiovascular disease risk factors (trials conducted on small groups of the target population);
• Phase II/III: confirmation of product efficacy for one or more metabolic and cardiovascular disease risk factors; determination of the daily dosage (trials conducted on a few hundred subjects in the target population).

The end goal is to provide unequivocal proof of safety and efficacy regarding risk factors for metabolic and cardiovascular diseases in the target populations. This is an essential condition for obtaining health claim authorizations from health authorities.