Headquartered in Verbania, on the shores of the Lago maggiore, in the Italian region of Piedmont, Abich is a Contract research organization (CRO) whose aim is to provide companies with testing and consulting services, also thanks to the subsidiaries it opened both in Italy and North America. The Abich laboratory was established in 2002 at the Lake maggiore Technopark with the main goal of developing innovative in vitro testing to check efficacy and safety of large consume products and ingredients. 13 years ago in vitro alternative tests were not so spread even if it was clear that the regulation was heading towards a replacement of animal testing with more sophisticated ones on human cells and tissues. A pioneer in the arena, Abich was appointed with an official Innovation award from the Italian Chamber of commerce in 2004. Throughout the years the company, a Contract research organization (CRO) has implemented a chemical and microbiological laboratory, with a wide range of performing techniques and innovative instrumentation; and created Alltox, a spin-off with the Laboratory of cell and molecular allergology at the San Raffaele Hospital in Milan, focused on skin allergy tests. In 2007 the Verbania facility was enlarged and two years later Abich inaugurated a new plant in Vimodrone (near Milan) for testing procedures on human volunteers. With a 2,000 square meters surface, its ISO 9001 and GLP-certified labs are mainly addressed to test cosmetics, medical devices and ingredients. To serve the needs of the US, Canadian and European clients and facilitate the technical compliance of products when exporting on these markets, in 2014 Abich opened a subsidiary in Montreal, Canada. Elena Bocchietto, director at the Verbania testing facility, gave KosWorld an overview of the Center’s activity.
What kind of services can Abich offer to the cosmetics industry today?
A CRO like Abich is the best partner for small-medium size cosmetic companies that require need testing, advice and consulting. We can develop small research projects, like designing new active ingredients, new formulation concept, or point out new efficacy/safety claims, always based on scientifically grounded assays and data. We can identify and screen ingredients or formulas for specific purposes, testing them on cells and human tissues in order to prove the mechanism of action. Thanks to the many analytical techniques (GC-MS, ICP, IR, UPLC and HPLC) the laboratory can check chemical composition, trace impurities and detect them, verify chemical stability. The microbiology lab can also investigate effectiveness of preservative system or screen antimicrobial properties of finished products and ingredients. We are finally able to test safety and effectiveness on human volunteers, with different clinical protocols supervised by skilled dermatologists and medical specialists.
Could You describe the different competences and goals of Your subsidiaries?
In Verbania the main laboratory provides services in analytical chemistry, cell and molecular biology, microbiology, R&D and consulting, while Vimodrone is focused on clinical testing on volunteers, with many medical specialists collaborating and supervising the activities. Our customers in Italy are represented by Italian, European and global companies. We also work with New Zealand and India; while in North-America, Abich Inc is a start-up dating at the end of 2014 and providing clinical testing, in vitro safety assays, microbiology, R&D and consulting. The US market is keen to acquire testing services in a nearby facility, familiar with the FDA regulations, and benefiting from a very favorable exchange rate. Canadian companies will also have big benefits in tax refunding when R&D activities are performed inside their country; while US and Canadian companies willing to export to Europe, can deal with a local laboratory that provides all the testing and documentation carried out according to the EU regulations and, if necessary, in a EU facility. Working on different sites allows us to split the urgent projects in the more available facility, reducing timing and skipping the problem of summer and holiday stops: in Montreal a shorter summer will enable us to test anti-age and sun products all along the year. The Canadian lab is also specializing in hair products testing, Italy is more focused on anti-age products.
What kind of skills are the most required from the cosmetics industry today, Mrs. Bocchietto?
In vitro assays and clinical tests on volunteers are definitely the most successful. The international regulations are always more addressing towards a scientifically-grounded and standard-based safety and efficacy testing to improve the quality of cosmetics. We must remember that according to FDA many European cosmetic products are considered as OTC in other countries, with stricter regulation and controls. For example we perform a very large number of SPF and water resistance tests both in Italy and North-America, where they are dubbed as OTC. Also in vitro testing is highly required both as screening test and as a complement to clinical testing. Also, the CLP regulation as well as other EU regulations requires that most toxicity test on ingredients, chemicals and mix (cytotoxicity, skin irritation, corrosion, eye irritation, skin sensitization, mutagenesis, phototoxicity, ecotoxicity and so on) are performed according to validated in vitro methods. Many official methods are currently available, and they are increasing every year. Furthermore we have now more than 150 in vitro methods to check every kind of biological activity that could be of interest. And the analytical chemistry assays are going to be more and more required, especially to trace unwanted impurities (nickel, heavy metals, phthalates, allergens, interdicted substances) or to check products stability (photostability, titration of preservatives, active ingredients or sun filters).
What does the term innovation mean to You and what kind of innovations are underway?
We started developing in vitro testing protocols on human cells fifteen years ago, when companies did not even know what in vitro meant, and continued to propose innovative protocols and testing systems. Customers are interested in quicker and easier ways to check the safety/compliance of products and ingredients, as well as to new claims to put on their label. We are creative and able to develop innovative testing to satisfy specific claims, like 24h hydration, 48h antiperspirant or eco-compatible and sea water-resistant; and fast in developing new products starting from the concept: investigating an unexploited herb or plant, to identify the interesting part of it, the active molecules and the biological activity, and also suggest the best extraction protocol, in a couple of months only. We have acquired a Blue Top Laser, a very advanced instrumentation able to scan in a very precise and scientific way all the face profile, able to record, behind the wrinkles definition, the volume and shapes changes in detailed area (under-eye bags, lip volume, eye lashes length). In the analytical chemistry field, we acquired a simultaneous ICP-OES that, once analyzed a sample, can keep in mind all the periodic table elements details and these data can be provided even years after, on demand. We have two UPLCs, that allows us to trace ppt (part for trillion) of molecules, performing percutaneous absorption assays with a very high sensitivity, even with small quantities of sample. Concerning the in vitro testing, we are the only one laboratory in Italy to perform the FL(fluorescein leakage) test according to OECD 460 to classify severe eye irritant and we are to implement a series of genotoxicity/carcinogenicity assays avoiding the use of animals.
Will the cosmetics market offer You new challenges and opportunities in the near future?
The cosmetics market is always more a global one and it is very important to think on a global level. We were the first company to develop and offer in vitro testing protocols in Italy, and we can build upon a very large panel of testing protocols, to be shared with our American facility. These are a powerful tool to investigate the nature of products and ingredients, and can be very effective when coupled to human clinical testing protocols to fully dress an innovative product for the global market. Borderline medical devices are also getting more and more important in the global market, and we are happy to say that we have a strong regulatory and testing experience in this field, that will help our customers once more to develop innovative products.
A FREE CALCULATING SPREADSHEET FOR SUNSCREEN PERFORMANCE
The SPF calculating spreadsheet comes from the knowledge Abich has of sunscreens performance coming from thousands of sun products tested in the last years. To better perform the in vivo SPF testing, especially for the volunteers’ safety, it is very important to correctly predict the SPF value of an unknown product, and the laboratory developed this tool by acquiring the reflection spectra of every single sunscreen, for internal use. It then saw that it could be useful for formulators, so decided to make it freely available on its Website abich.it. Fully independent from of any commercial manufacturers of sunscreens, it was created by underestimating a bit the sun protection of each molecule, in order to be quite sure to pass the in vivo test. When using it, it must anyway be kept in mind that other ingredients in the formula can modify the in vivo data, like anti-inflammatory ingredients or very volatile ones.
ALL ABOUT ALLTOX
The spin-off Alltox was created with the Laboratory of cell and molecular allergology at the San Raffaele Hospital, Milan, in 2003 to investigate the topical response to allergies and we developed a wide range of skin sensitization tests very effective and predictive. Abich can then offer Human cell activation test, both performed on monocytes or on dendritic cells, and assays to evaluate the THP-1 and THP-2 immune response, as well as test to detect the ability to inhibit sensitization. Also, it performs the LLNA (Local Lymph Node Assay) the only one alternative test fully validated to replace the GPMT (Guinea Pigs maximization Test).