Cerbios welcomes a comprehensive review on the efficacy and safety of its E. faecium SF68® probiotic
Press Release | Cerbios-Pharma SA
MAY 21, 2018
Lugano, Switzerland: – Pharmaceutical ingredient specialist Cerbios-Pharma SA (Cerbios) has announced the publication of a scientific review on the efficacy and safety of its proprietary probiotic active ingredient Enterococcus faecium SF68® (SF68®).
Cerbios markets SF68® for the prevention and treatment of gastrointestinal disorders.
The publication of the study (Holzapfel et al., 2018) coincides with the 50th anniversary of the discovery of the probiotic strain and provides a comprehensive overview on the huge amount of scientific information available regarding efficacy and safety of SF68® as a pharmaceutical probiotic.
Safety and efficacy of SF68
In an article, published in the scientific journal Beneficial Microbes, extensive information is provided on the efficacy and safety of SF68®, supported by well-established scientific and surveillance data.
The review entitled ‘Enterococcus faecium, SF68 as a model for efficacy and safety evaluation of pharmaceutical probiotics’ is authored by scientists acknowledged as experts in the field of probiotics. Among them first author Prof. Wilhelm Holzapfel of Handong Global University and Prof. Bruno Pot from the Research Group of Industrial Microbiology at Vrije Universiteit Brussels (VUB).
Beneficial strains of E. faecium
As written in the review, the species E. faecium has attracted increased attention “thanks to beneficial strains marketed as probiotics, and because of its beneficial role in traditional fermented foods such as artisanal cheeses in some Southern European countries.”
However following reports on the increasing association of some enterococcal strains with nosocomial infections such as endocarditis and bacteraemia, frequently highly resistant to ‘last-defense-line’ antibiotics such as the glycopeptide derivatives, enterococci have been classified in risk group 2 in the European Directive 93/88.
E. faecium SF68® as a model for the evaluation of safety of probiotic strains
The review discusses also the subgroups within the E. faecium species as well as the possible taxonomic separation into subspecies, thus enabling the formal definition of a qualified presumption of safety (QPS) subgroup as already suggested by the European Food Safety Agency (EFSA, 2016).
“This could avoid confusion in the literature when, e.g. discussing the safe use of probiotic preparations based on E. faecium strains,” the review concludes.
“We propose the approach presented above as a model for the evaluation of safety at the strain level, going beyond QPS,” say the authors.
Best characterized probiotic
“This article is in line with our experience of more than 30 years distribution to patients in different markets where SF68® has gained importance thanks to its beneficial effects for the prevention and treatment of gastrointestinal disorders without any adverse events,“ commented Cerbios CEO, Dr. Gabriel Haering.
“In fact, SF68® has been used for decades both for human and animal health applications and is considered as one of the best characterized probiotic with respect to efficacy and safety with an exceptionally long history of safe use in probiotic therapy,” Dr. Haering adds.
Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacturing of both chemical and biological APIs for its partners world-wide.
Cerbios’ is a global leading supplier of a portfolio of Generic APIs primarily used for the treatment of Respiratory and Dermatological disorders as well as in Oncology.
Exclusive, CDMO services are offered for the development and manufacturing of HPAIs as well as for Biological products including monoclonal antibodies, recombinant proteins, Antibody Drug Conjugates (ADCs) and pharma probiotics.
Cerbios provides full CMC support, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.
Since 2015, Cerbios has been a member of the ADC manufacture PROVEO™ consortium, forged with AGC Biologics of Denmark and with Germany’s Oncotec.
PROVEO can offer an end-to-end service for ADCs, from substance development through manufacturing to fill & finish.
SF68® is a probiotic active ingredient of pharmaceutical quality produced by Cerbios-Pharma SA and is contained in pharmaceutical probiotics such as Bioflorin®, Newflora®, Neoflor®, Diaflor® and Ventrux®.
It is approved as a pharmaceutical probiotic by the health authorities of different countries, starting from Switzerland in 1979.
Besides its application as pharmaceutical probiotic it is approved by EFSA under the name of the strain deposit E. faecium NCIMB 10415 as a ‘gut flora stabilizer’ for various animal categories.
Chiara Brusadelli, Commercial Operations Assistant Manager, Cerbios-Pharma SA
Tel: +41 91 985 63 11
Click on Cerbios welcomes a Review on efficacy and safety of SF68® for more information.
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The original publication is available at this link: Beneficial Microbes to see article abstract.
Click on SF68 Review to download original study.