What is the BIO-S project?
Servier is redeveloping its medicines production number 3 unit at its site in Gidy, France, to transform it into an investigational medicines bioproduction unit. This project is a turn-key solution which covers all stages of preparing ready for use medicines, through the production of medicines originating from biotechnologies, for pre-clinical and clinical studies.
What is a biomedicine?
Biomedicines represent a new generation of therapies, based on a biological source such as a raw material of an active substance. They are a major innovation in terms of treatment and a crucial step towards personalised medicine. For more information visit, click here
What is the difference between a clinical batch and a pre-clinical batch?
Pre-clinical studies help to evaluate the activity, tolerance and toxicity of a new product. These studies are, initially, conducted in vitro then, at a later stage, in vivo. These studies are essential prior to conducting clinical trials on humans.
Clinical studies, performed on humans, are conducted to evaluate the safety of use as well as the effects of the product in the body (Phase I), to define and validate the therapeutic dose of the molecule according to a given disease (Phases II and III).
What types of medicines will be produced within the BIO-S unit?
The BIO-S unit will produce biomedicines (recombinant proteins, monoclonal antibodies, bi-specific antibodies), which are made from genetically modified mammalian cells. Biomedicines are able to recognise specific antigens present on cancer cells.
What is the operating procedure with R&D in the Group?
The purpose of the BIO-S unit is to produce pre-clinical and clinical batches for our R&D prior to the marketing of biomedicines. R&D is integrated into BIO-S with the pharmaceutical and analysis laboratories; project managers specialised in the production of active substances originating from biotechnology are integrated into the projects which are developing the products.
What are the different phases of the project?
Phase 1: a pilot unit (Bio-engineering) will allow optimisation and production of (non-clinical) batches for research. This should be operational by the end of 2019.
Phase 2: the BIO-S project will have the capacity to manufacture clinical batches in 2020.
How will the bioproduction project form part of the Group’s strategy?
The project for transforming the production site in Gidy forms part of the Group’s strategic objectives: to launch a new molecular entity every 3 years, to become a leading player in the field of oncology.
The bioproduction unit in Gidy, will help to support the research of Servier, through the production of biomedicines, particularly in the field of oncology. It will also help to make innovative medicines available more quickly to patients and the medical profession.
The Servier Group has invested 50 million Euros over 3 years for the project
BIO-S will ultimately occupy a surface area of 3 500 m²
By 2020, 60 people are expected to be dedicated to bioproduction