NEWS

NEWSLETTER

1

AUG

2017

NEWSLETTER 9/2017 BIO BASIC LAB – FROM THE SCIENTIFIC RESEARCH AN INNOVATIVE EXPERIMENTAL PROTOCOL TO EVALUATE IN VITRO THE EFFICACY OF AFTER-SUN PRODUCTS ©

It is well known the important function of after-sun products in relieving the effects resulting from sun exposure and in improving the skin conditions by increasing the hydration, through a soothing, refreshing and restructuring action.

In order to be able to evaluate in vitro the efficacy of that specific typology of cosmetic products, Bio Basic Lab has developed a new protocol, structured on three different levels. This allows demonstrating the repairing action against the damages caused by UV radiations, both in terms of improvement of cell conditions and of repair against the oxidative damages, and demonstrating the soothing action.

The test is performed on keratinocytes cell coltures and it is based on the following evaluations:

-Vitality evaluation and possible total protein dosage after different times of application of the product, following UV radiation.

- Evaluation of the oxidative damage reduction, derived by the exposure to UV radiation, through a dosage of free radicals, produced by those cells treated with the product under test.

- Evaluation of the soothing action through an analysis of IL 1α synthesis in those cells treated with the cosmetic product under test, after exposure to UV radiations.

Thanking you for your attention, we remind that we are always available to provide more information and to develop the most suitable experimental protocols for meeting your specific requirements, and to your different cosmetic formulations.

BIO BASIC EUROPE
In Vitro Tests Responsible
Dr.ssa Eliana Regola +39024155729 testing@biobasiceurope.it

BIO BASIC EUROPE
Technical Director
Dr. Claudio Angelinetta

BIO BASIC EUROPE
Managing Director
Dr. Umberto Pianca

27

JUL

2017

NEWSLETTER 8/17 BIO BASIC EUROPE CONFIRMS ITS QUALITY CERTIFICATION IN COMPLIANCE WITH UNI EN ISO 9001:2015

On Monday 30th May 2017 it was held a day of audit by SQS inspectors (Swiss Association for Quality and Management Systems) of Bio Basic Europe Quality Management System.

We are glad to inform that once more this year we reconfirm our quality certification, working in compliance with the UNI EN ISO 9001 requirements, updated to the 2015 edition.

Bio Basic Europe Management commits to running the processes by increasing the customer’s satisfaction and improving continuously the internal organization, and to sharing this vision with all the staff.

For this reason Bio Basic Europe ensures continually services of clinical and laboratory testing, and technical-scientific, marketing and regulatory consultancies, in compliance with the statutory and regulative law requirements.

In accordance with the updated version of the standard, we have further explored the analysis of our business context, and checked any possible risk and opportunity of our sector.

The inspectors have particularly appreciated the dedication of all the staff, the presence of an internal Quality Office well prepared and constantly updated, and the attention of the Management to organize, measure and monitor, improving on a continuous basis, the efficacy of the entire System.

In case of need of further information about Bio Basic Europe Quality Management System, or to ask a copy of our ongoing certifications, do not hesitate to contact the Quality Office, whose references are mentioned below.

Quality Management System Responsible
Dr. Claudio Angelinetta

Quality Management System Representative
Dr.ssa Ilenia Bertazzo – relation@biobasiceurope.it
Dr.ssa Francesca Toja – secretariat@biobasiceurope.it
Tel. +39 024155729

BIO BASIC EUROPE S.r.l.
Managing Director
Dr. Umberto Pianca

12

JUN

2017

NEWSLETTER 7/17 NEW “MDR” (Medical Device Regulation) 2017/745

We inform that on the 5th May 2017 it has been officially published the new European Regulation “MDR” (Medical Device Regulation) 2017/745, which entered into force on the 26th May 2017, and that amends the 90/385/CEE Directive concerning Active Implantable Medical Devices, and the 93/42/CEE Directive concerning Medical Devices.

The new “MDR” (Medical Device Regulation) 2017/745 is intended to improve the Medical Devices safety through strict controls, making the obligations of the manufacturers, together with the supervision role carried out by the Notified Bodies, more stringent. The desired effect is to guarantee greater benefits for the patients, while maintaining a timely access to innovative solutions in the field of healthcare.

The manufacturers of Medical Devices sold in Europe, will have a transitional period of three years (till the 26th May 2020) in order to adapt to the new requirements. Certain parts of the Regulation are, however, already of interest to some manufacturers and Notified Bodies.

Bio Basic Europe has established internally a Department dedicated to Medical Devices, highly prepared about the subject and constantly updated on the relevant legislation. Below are mentioned the main changes regarding “MDR” (Medical Device Regulation) 2017/745:

• MEDICAL DEVICE DEFINITION EXTENDED: the definition of “Active Implantable Medical Devices” and “Medical Devices” has been extended, to include also those Medical Devices which do not have a medical intended use (for example “coloured contact lenses”, “hyaluronic acid filler”, “silicone implants” etc.).

• CLINICAL TRIALS: it is requested to perform clinical trials to ensure the safety and the clinical performances of each Medical Device according to the associated risk, and to perform comparative studies among Medical Devices. There is the obligation for manufacturers to store all the documentation, also post-marketing, to allow a continuous evaluation of the potential risks concerning the safety in the long term and for a large scale.

• QUALIFIED PERSON: manufacturers shall identify within their organization a “qualified person” who has the responsibility of the Medical Device compliance with the essential requirements of the new regulation.

• UNIQUE IDENTIFICATION (UDI): it is introduced the UDI (Unique Device Identification), a unique identification code of the Medical Device to be included in the label, in order to improve the traceability and the recalling of those products potentially dangerous to health.

• EUROPEAN DATABASE “EUDAMED”: the EUDAMED database will be extended to enhance transparency and to facilitate access to data by the public and the healthcare professionals, and to strengthen the communication among European states.

• STRICT POST-MARKETING SUPERVISION: carried out by the Notified Bodies, for example asking every year the manufacturer to present a document which shall confirm the post-market, safety and performance data concerning the Medical Device.

• COMMON SPECIFICATIONS: European Commission together with a group of experts will publish some “common specifications” which the manufacturers and the Notified Bodies shall take into consideration.

Let us remind that Bio Basic Europe has an internal research centre specialized in safety and efficacy evaluations “CDC Dermo-Clinical Research Centre”, with a team of qualified dermatologists led by a C.R.C. (Clinical Research Coordinator). C.R.C. allows us – supported by relevant Ethical Committees – to deal with the request of clinical trials, to guarantee the safety and efficacy of Medical Devices.

Thank you for your attention and please contact us to get some more information or to arrange an appointment with a dedicated consultant.

Technical Director
Dr. Claudio Angelinetta

Medical Device Dpt Responsible
Dr.ssa Silvia Busoli Badiale doc@biobasiceurope.it +39024155729

Medical Device Dpt Assistant
Dr.ssa Giulia Capasso doctest2@biobasiceurope.it +39024155729

BIO BASIC EUROPE S.r.l.
Managing Director
Dr. Umberto Pianca

22

MAY

2017

NEWSLETTER 6/17 CAREER DAY PORTE APERTE ALLE IMPRESE - 17 MAY 2017 - PAVIA UNIVERSITY

On the last 17 May, Bio Basic Europe attended the event "Porte Aperte alle Imprese", planned every year to allow a direct meeting among Institutions, companies, young students and new graduates coming from all the disciplinary areas of Pavia University.
Bio Basic Europe actively participated with a own stand, and met qualified students, providing them with information about Bio Basic business and collecting the resumes of the interested students and graduates.

If you want to know more please follow us on our LinkedIn page
https://www.linkedin.com/company-beta/10982723

7

APR

2017

NEWSLETTER 5/17 ADVANCED ANALYSIS EQUIPMENT IN IN-VIVO EFFICACY TESTS TO SUBSTANTIATE INNOVATIVE CLAIMS – COSMETORAMA 22 MARCH 2017

As mentioned previously, Bio Basic Europe attended the ninth edition of the event “Cosmetorama” organized by the Hellenic Society of Cosmetology and held on the 22nd March in Athens Greece, which this year was dedicated to the claim substantiation topic.

We showed to the public two scientific reports, concerning respectively the in-vivo efficacy test area, and the in-vitro analysis one. We desire to sum up, as follows, the main contents of these presentations, together with the relevant activities that our team of qualified professionals is able to perform.

• ADVANCED ANALYSIS EQUIPMENT IN IN-VIVO EFFICACY TESTS TO SUBSTANTIATE INNOVATIVE CLAIMS - Dr.ssa Roberta Villa (In Vivo Efficacy Test Department)

We presented some new technologies used in Bio Basic Europe, based on the images analysis, extremely important to substantiate new generation claims. In order to perform our clinical experimental protocols, among the equipment that allows getting precise and reproducible measurements, the following are certainly of great significance:

- Go!SCAN 3D - 3D Scanner: instrument able to record any data concerning body surface. Those data can be used to build 3d rotatable models of the body, and to obtain punctual and accurate measures of circumferences and body volumes. It allows us to clearly see the silhouette reduction after a treatment (reduction expressed in cm3).

- BodyMetrix™ Adipometer: system which allows measuring the thickness (mm) of the subcutaneous adipose tissue, thanks to an ultrasound technology.

- Antera 3D®: instrument that allows acquiring high resolution and three dimensional images. It let us to calculate a wide range of parameter, among which: volume, area, depth, wrinkles width and length, skin roughness (Ra, Rq parameters); dark circles visibility (melanin and erythema indexes); stains visibility (melanin index); skin redness (erythema index); eye bags volume and area; pores volume, area, density and depth; lips volume; scars and stretch marks volume and area (volume, area and lengths measure are expressed in mm3/mm2/mm).

- HIROX – RH 2000: 3D Digital Microscopy System able to capture high level images, with the aim of performing precise analysis of hair (clinical analysis, hair diameter), eyelashes (curvature, length, diameter and volume), skin texture and nails structure (clinical analysis, thickness) (volume, area and lengths measure are expressed in mm3/mm2/mm).

Our team of the In-Vivo Test Area is always available to provide you with more information.

For further references:
Technical Director
Dr. Claudio Angelinetta

In Vivo Efficacy Test Department
Dr.ssa Roberta Villa +39024155729 labtox2@biobasiceurope.it

Thank you for your attention,

BIO BASIC EUROPE S.r.l.
Managing Director
Dr. Umberto Pianca

7

APR

2017

NEWSLETTER 4/17 IN VITRO TEST AS AN INNOVATIVE INSTRUMENT TO ASSESS THE SAFETY AND EFFICACY IN SUPPORT OF NEW GENERATION CLAIMS – COSMETORAMA 22 MARCH 2017

As mentioned previously, Bio Basic Europe attended the ninth edition of the event “Cosmetorama” organized by the Hellenic Society of Cosmetology and held on the 22nd March in Athens Greece, which this year was dedicated to the claim substantiation topic.

We showed to the public two scientific reports, concerning respectively the in-vivo efficacy test area, and the in-vitro analysis one. We desire to sum up as follows the main contents of these presentations, together with the relevant activities that our team of qualified professionals is able to perform.

• IN VITRO TEST AS AN INNOVATIVE INSTRUMENT TO ASSESS THE SAFETY AND EFFICACY IN SUPPORT OF NEW GENERATION CLAIMS – Dr.ssa Eliana Regola (In Vitro Test Responsible)

We presented three particular in vitro tests (1 safety test, 2 efficacy tests) performed within our laboratory (Bio Basic Lab – Parco Tecnico Scientifico of Pavia University) to evaluate the safety and efficacy of cosmetic products/medical devices, supporting new generation claims.

SAFETY TEST

- ALTERNATIVE METHOD TO EVALUATE THE PRO-SENSITISING ACTION OF COSMETIC PRODUCTS/MEDICAL DEVICES
It is a morphological evaluation of THP-1 cells, performed with a cytofluorimetry analysis (Light scatter signals analysis (FSC/SSC)), which allows to discriminate damaged cells from the ones with a normal morphology.
Substances characterized by known pro-sensitising properties, are able to cause in the cells morphological modifications, consequently the evaluation of the cell morphology appears a rapid and easy method to identify the pro-sensitising action of cosmetic product/medical device.
This evaluation can be performed as a preliminary screening or to support the method normally used (OECD 442E-In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT))

EFFICACY TESTS

- EVALUATION OF THE MUCO-ADHESIVENESS OF OPHTHALMIC PREPARATIONS ON RECONSTRUCTED CORNEAL EPITHELIUM
Through a colorimetric reaction (spectrophotometric evaluation) we are able to quantify the accessible/not accessible sites for the mucus-adhesion on reconstructed corneal epithelium, and, consequently, to evaluate the efficacy of ophthalmic preparations in increasing the time of permanence on the epithelium, growing the bioavailability of the active principles contained therein.

- ANTI-POLLUTION TEST
In vitro evaluation, in terms of cell viability, of the protective and repairing action of a cosmetic product, towards environmental factors (UV, cigarette smoke, urban pollution and/or heavy metals standards) both on cell coltures and on reconstructed skin models.
We are developing within our laboratory some protocols to evaluate those actions, through an assessment of the modulation of interleukins production and modulation/neutralization of free radicals, both on cell coltures and on reconstructed skin models.

Our team of the In-Vitro Test Area is always available to provide you with more information.

For further references:
Technical Director
Dr. Claudio Angelinetta

In Vitro Test Responsible
Dr.ssa Eliana Regola +39024155729 testing@biobasiceurope.it

Thank you for your attention,

BIO BASIC EUROPE S.r.l.
Managing Director
Dr. Umberto Pianca

3

APR

2017

NEWSLETTER 3/17 IN-COSMETICS GLOBAL 04-06 APRIL 2017 LONDON

We are glad to inform that Bio Basic Europe is attending from the 04th to the 06th of April the 27th edition of “In-Cosmetics Global” in London, an event dedicated to the cosmetic sector, and in particular the leading event for personal care ingredients.

It is expected the participation as exhibitors of 800 international companies, suppliers of ingredients, fragrances, lab equipment, testing and regulatory assistance, with visitors coming from 121 different countries.

BIO BASIC EUROPE S.r.l.
Managing Director
Dott. Umberto Pianca

20

MAR

2017

NEWSLETTER 2/17 CONFERENCE COSMETORAMA “CLAIM SUBSTANTIATION” – 22 MARCH 2017 ATHENS (GREECE)

We are glad to inform you that Bio Basic Europe S.r.l. will attend on the 22nd March 2017 in Athens (Greece) the ninth edition of “Cosmetorama”, an event dedicated to the cosmetic sector, arranged by Hellenic Society of Cosmetology.
In this edition the main topic will be the “cosmetic claim substantiation”.

Two sessions will be held by Bio Basic Europe internal speakers, who will explain to the public two scientific presentations about in vivo and in vitro tests:

• ADVANCED ANALYSIS EQUIPMENT IN IN-VIVO EFFICACY TESTS TO SUBSTANTIATE INNOVATIVE CLAIMS - Dr.ssa Roberta Villa (In Vivo Efficacy Test Department);

• IN VITRO TEST AS AN INNOVATIVE INSTRUMENT TO ASSESS THE SAFETY AND EFFICACY IN SUPPORT OF NEW GENERATION CLAIMS – Dr.ssa Eliana Regola (In Vitro Test Responsible)

BIO BASIC EUROPE S.r.l.
Managing Director
Dott. Umberto Pianca

20

MAR

2017

NEWSLETTER 1/17 MASTER DEGREES “PLUS” – NETWORKING BETWEEN COMPANIES/STUDENTS

We are glad to inform that Bio Basic Europe will participate on the 22nd March 2017 at 03.00 PM, within the Aula Magna of Pavia University headquarter, to the first networking event among companies, students and professors, for what it concerns the project “Master Degrees PLUS, LM+”.

As mentioned last year in a past newsletter, Bio Basic Europe is one of the companies involved in this project, offering to the students who are enrolling to the master degree course in Advanced Biotechnology, the possibility to attend two semesters as a formative training within our laboratories.

The conference which will be held on the 22nd March is an opportunity to the interested LM+ students of meeting the companies together with their professors, and discussing further of the project.

The networking day will be for Bio Basic Europe an occasion to explore the interest of the students, to show all the areas in which it will be possible to experience the internship (they can be done within the microbiological, chemical-physical, in vitro laboratories of Bio Basic Europe, in the Parco Tecnico Scientifico) and to know the students’ thesis plans under definition.

To get more information please have a look at the official site: http://news.unipv.it/?p=19994

BIO BASIC EUROPE S.r.l.
Managing Director
Dott. Umberto Pianca

Dermo-cosmetic and medical R&D center