The Pharmabiotic Research Institute (PRI) is Preparing to Publish its First Works on the Therapeutic and Medicinal Potential of Probiotics
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
– 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
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
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)