A target product profile (TPP) outlines the desired ‘profile’ or characteristics of a target product that is aimed at a diseases. TPPs state intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. Such profiles can guide product research and development (R&D):
IN INDUSTRY : In-house target product profiles (TPPs) are used as planning tools that guide development towards desired characteristics.
IN THE REGULATORY CONTEXT : TPPs are considered as tools to frame development in relation to submission of product dossiers.
IN THE CONTEXT OF PUBLIC HEALTH : TPPs set R&D targets for funders and developers
Facilities and capabilities
Vibiosphen is located in Prologue Biotech, a biotech business incubator (ISO 9001) in Labège, near Toulouse, South of France. Vibiosphen has at disposal, in this high technical and scientific quality environment:
- state of the art technologies (microbiology, molecular biology, histology…)
- BSL2 (biosafety level 2 laboratory and animal facilities)
- BSL3 (biosafety level 3 laboratory and animal facilities)
Regulatory and quality management
We comply with good laboratory practice or GLP to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development.
All the studies are carried out according to the standard operating procedure in place at the test facility. All procedures are performed in accordance with the Directive 2010/63/UE recommendations and with French Veterinary Authorities agreement.
All animals are managed similarly, with due regard for their well-being, according to prevailing practices and the current SOPs in force at Vibiosphen. The in vivo design and procedures was approved by Ethical Committee.
Microorganisms and cells libraries
Gram negative and Gram positive, aerobic/anaerobic, pathogenic/commensal resistant bacterial strains, ESKAPE.
DNA and RNA vírus Sars-Cov-2, influenza H1N1, RSV A2, MS2 phage.
Candida, Aspergillus, Trichophyton, Malassezia.
A549, A549-hACE2, Hep-2, Hep-G2, McCoy, Caco2, MDCK, Vero E6, HFF-1 and MRC-5.