R&D centers

VALBIOTIS R&D in France

Three R&D centers to develop innovative, plant-based healthcare products

To develop its products, VALBIOTIS has constructed a unique properietary tool: VALBIOTIS R&D, an integrated Research and Development platform, specifically designed for researching plants and their applications in the field of metabolic diseases.
This cross-disciplinary entity brings together expert teams and infrastructures focused on plant-based chemistry, preclinical research on the metabolism and clinical development.
VALBIOTIS R&D ensures its entire product development chain, from discovering active ingredients to clinical trials on humans.

The scale of this construction was designed to increase the creation of value over the long-term and to ensure the sustainable autonomy of VALBIOTIS.

Key figures

Staff

70%

of the workforce at VALBIOTIS are assigned to Research and Development.

Patents

4

patent families filed by VALBIOTIS since 2014.

Infrastructures

2600

square meters of which 1,200 m2 is dedicated to Discovery and Preclinical Research.

Publications

8

publications selected by international scientific and medical conventions since June 2016.

1. A center of expertise for plant-based chemistry

In partnership with La Rochelle University and the CNRS, the La Rochelle center is leading the research and the analysis required to develop and perfect active ingredients. This work is conducted by teams specialized in plant-based chemistry and biotechnologies.
The center for plant-based chemistry ensures:

  • The development of extraction processes conducted on raw plant materials and the complete characterization of the extracts obtained (identification of biomolecules, in particular);
  • The perfecting of plant combinations;
  • The purification and pharmacomodulation of biomolecules and certain plant extracts using the latest bioengineering technology;
  • The industrial application of procedures in conjunction with our external partners.

These teams also monitor the compliance of the raw plant materials used, in line with recognized standards, such as the European (EDQM) and American Pharmacopoeias. This compliance reflects the desire of VALBIOTIS to apply pharmaceutical quality standards to healthcare products of natural plant origin.

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

A state-of-the-art tool for GLP standards (Good Laboratory Practices), the platform for Discovery and Preclinical Research is responsible for evaluating the potential of active ingredients and for conducting all the preclinical studies required to begin the initial clinical studies on humans.
Installed in Riom (France) over an area of 1,200 m2, this cutting-edge scientific site is equipped with:

  • A large in vivo screening capacity for metabolic disease models;
  • Latest-generation equipment and methods, designed for studying the metabolism of living beings on all levels;
  • Application of the highest quality standards.

As specialists in the study of the metabolism, the research teams lead all in vitro and in vivo investigations, generating data on a large scale, relating both to the efficacy of VALBIOTIS products as well as to their mechanisms of action.

Specific techniques for studying the metabolism, on all biological levels

In vivo models: Diabetes, obesity, dyslipidemia, NAFLD

Cellular culture

Biochemistry: Enzymatic testing, plasmatic dosages, ELISA

Molecular biology: mARN extraction/RT-QPCR, ELISA, Western Blot, etc.

Physiology: microsurgery, hyperinsulinemic-euglycemic clamp

Histology platform

Body composition, EchoMRI

Indirect calorimetry

Mitochondrial respiration

Radiolabeling in vivo

3. Clinical development center: the highest standards to reduce the risk of metabolic diseases

Once validated by preclinical studies, each product is subject to a rigorous clinical development in order to demonstrate its safety, tolerance and efficacy on target populations.
These development plans are designed and overseen by the clinical research center based in La Rochelle.
The clinical studies are conducted by CROs (Contract Research Organizations) in collaboration with University Hospitals in France and abroad (Europe, the United States and Canada). Each study is conducted in compliance with Good Clinical Practices (GCP) and in line with ICH standards*.

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

Two-Phase clinical plans

  • Phase I/II: evaluation of product safety and tolerance, obtainment of the proof of concept (15 to 40 people);
  • Phase II: proof of product efficacy on one or several of the risk factors of metabolic diseases, determination of the daily dosage (several trials generally involving over 400 people in total).

The end goal is to provide an unequivocal proof of safety, tolerance and efficacy on the risk factors of metabolic diseases in target populations. This is an essential condition for obtaining health claims from health authorities.