PARIS, December 13, 2011 /PRNewswire/ --
- The Pharmabiotic Research Institute (PRI) brings together industrial and academic players in the area of probiotics research. It is a unique scientific and regulatory association in Europe.
- The PRI asserts that, beyond their traditional food processing applications, probiotics can also be active pharmacological constituents with preventive and curative potential. This is why PRI uses the terminology "Pharmabiotics", relating to "LBP - Live Biotherapeutic Products" rather than "Probiotics".
- In 2012, the PRI will publish its first works, underway since 2009 through various working groups relating to the adaptation of the general directives provided by the CTD format (Common Technical Document - used for the qualification of drugs) to the specificities of Pharmabiotics.
- The PRI initiative echoes the ever increasing number of scientific publications (more than 100 per month on average), of which the proof of concept attests to a scientific consensus emerging around the therapeutic potential of probiotics.
THE PRI: a French association which has become a single European structure, a federation of more than 40 members throughout Europe
- The PRI is a federation of groups with both academic and industrial competences, working for the development of probiotics, from the fundamental research to the industrial production of the end product.
- Created at the end of 2009 in Aurillac, it is chaired by Professor Michel Dapoigny, gastroenterologist at the University Hospital of Clermont-Ferrand.
- The PRI today counts 42 federated members coming from the pharmaceutical industry, the university world and research. Nevertheless, the number of members continues to increase. As a whole, the members, whose competences include research in microbiology and/or pharmacological development, are involved in research, development, production and the marketing of probiotics.
- Labelled a "cluster of excellence" in 2010, PRI is independent. It is financed mainly by its members and also by subsidies from local public funds (Auvergne Region), national public funds (French State) and European public funds (ERDF).
PRI asserts that probiotics can potentially also be used for their pharmacological properties and thus speaks about "Pharmabiotics"
- Probiotics are widely used by the food industry, however, the use of probiotics goes much beyond this. In fact, they can be used for their therapeutic properties, in a curative or preventive manner. In this precise case, the PRI prefers speaking of Pharmabiotics.
- Generally, the World Health Organization (WHO) gives the following definition of probiotics: "Living organisms, which, when administered in suitable quantity, confer health benefits on the host."
- In this family of probiotics, PRI more particularly identifies Pharmabiotics, i.e. probiotics whose "health benefit" can be clearly connected with the prevention or the cure of a disease. In this direction, PRI relates Pharmabiotics to "LBP" or "Living Biotherapeutic Products", containing living micro-organisms, which formulated alone or with other excipients, have pharmacological, immunological or metabolic properties aiming to restore, correct or modify physiological functions.
In 2012, the PRI will publish its first proposals for an adaptation of the general directives of the CTD format to the specificities of Pharmabiotics
The properties of Pharmabiotics, since they are therapeutic, must be understood according to the pharmaceutical criteria of the drug. However the CTD format governing the regulatory framework of the drug gives general directives, some of which need to be clarified to take into account the specificities of Pharmabiotics.
It is in this field that the works of PRI offer some suggestions, by federating several multi-disciplinary work groups composed of industrial players and scientific academic players.
This group is responsible for defining the minimum level required for the identification of strains at the initial stage of characterisation, at the stage of the bank of mother cells and the bank of active cells, at the stage of quality control during the production of living biotherapeutic micro-organisms (LBM) and living biotherapeutic products (respectively the equivalent of API and the drug), and the follow-up of the strain during pre-clinical and clinical studies.
The group also defines the minimum level required for the description of the inherent characteristics of the strains which could potentially impact health (resistance to antibiotics or antifungals, factors of virulence, etc).
This group is responsible for the adaptation of the guidelines relating to the manufacturing process: the checking of materials, the follow-up of the development of the LBM (API) and the LBP (drug), the description of the lumbago (drug) and its composition, levels of crossed contamination, analytical procedures and their validation, standards of reference, and the stability of the LBM (API) and the LBP (drug).
This group is responsible for the adaptation of the directives which treat pre-clinical and clinical studies of the lumbago (drug). In the case of the pre-clinical studies, the group works on the directives relating to pharmacodynamics, the pharmacokinetics, safety and toxicity. At the clinical level, the group works on the adaptation of the guidelines relating to clinical trials, in particular those related to pharmacokinetics and pharmacodynamics, as well as to the various tests carried out on healthy volunteers and patients.
An independent scientific committee will review the results of the various working groups and will summarise them. PRI will then submit them to EMA, thus offering its full contribution to the definition of the regulatory framework of the Pharmabiotics of tomorrow.
The growing number of scientific publications attests that probiotics have a proven medicinal potential in many therapeutic segments
This therapeutic potential is clearly shown by numerous works concerning every area of the organism presenting a flora and involving numerous pathologies, for example, in the case of the gastro-intestinal tract, inflammatory diseases of the intestine or obesity; periodontitis in the oral area; in the higher air routes infections of the ears, nose, and throat; and finally, in the female urogenital system, sexually transmitted diseases, urinary or vaginal infections. In all these cases, publications have shown a positive effect of probiotics in the prevention or on the evolution of these pathologies.
PRI is also, through its website, a place of expression, in images, for health professionals and experts in probiotics. The site also offers the possibility of following the latest developments in probiotics and offers a calendar of associated events.
|SOURCE The Pharmabiotic Research Institute (PRI)|
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