Oroxcell, a contract research organization (CRO) specialized in the invention and development of alternative approaches for research establishments and industrial companies, announces that it has been granted good laboratory practice (GLP) certification under the 2004/9/EU directive (safety testing), following an inspection by the French Health and Safety Agency (Agence Française de Sécurité Sanitaire des Produits de Santé – Afssaps).
The inspection was carried out on January 18 and 19 this year at the company’s premises in the Biocitech life sciences technology park, where it has been established since 2004. The inspection resulted in Oroxcell’s laboratories receiving Grade A GLP compliance certification, which relates to tests on medicines for human use and cosmetics and covers the following areas of activity: skin irritation and corrosion, validation of bioanalytical methods, bioanalysis, and cytochrome induction and inhibition.
GLP certification will enable Oroxcell to strengthen its position on the regulatory market of alternative methods, which is booming. In effect, the relevant European directives encourage researchers to switch to new models that are alternatives to the use of laboratory animals in all areas, and especially in the field of cosmetics, where animal testing is now banned.
Oroxcell applies its culture of innovation to the development, validation and setting up the production process of alternatives to the use of laboratory animals, and its expertise in bioanalysis and cell and tissue testing to the evaluation of the bioavailability and toxicity of products.
“Oroxcell is an innovative company operating at the crossroads between several disciplines, which enables it to reconcile the benefits of its different sectors of activity and drive the innovation process further,” said the President of Biocitech, Jean-François Boussard. “It has developed novel and advanced technologies and has now given its business added value with this certification. The park’s supportive environment and its ultra-modern and safe premises have helped Oroxcell achieve this distinction. We congratulate the whole team on attaining this new milestone in their development.”
“Oroxcell knows how to innovate, develop, internationally validate and industrialize alternative testing methods,” noted Oroxcell’s chairman and scientific director, Jean Pachot. “Oroxcell has secured this GLP certification through substantial human and financial investment, reflecting its longstanding commitment to improving quality and developing innovation. This certification will enable us to push ahead with our development projects at the service of human health and the safety of our clients’ products by offering them a real guarantee.” And he added: “With its integrated, automated platform, Oroxcell is recognized as the European leader in the exclusive provision of alternative methods. With this Afssaps certification, the company becomes an indispensable player in the implementation of its clients’ projects.”
Oroxcell is an independent research organization (CRO) offering research services focused on assessing the bioavailability and toxicity of compounds originating in the life sciences and chemical industries. Oroxcell is developing its business on two fronts:
– Services: It has developed a technology platform for performing in vitro ADMET (Absorption, Distribution, Metabolism, Elimination and Toxicity) tests, bioanalytical studies, and the calculation of pharmacokinetic parameters for evaluating products developed by the pharmaceutical, cosmetics, food, home care, chemical and veterinary industries.
– Innovation: Oroxcell has developed alternatives to the use of laboratory animals. It is investing in the development and validation of new technologies, such as the HCE (human corneal epithelium) model for assessing the eye irritation potential of chemical substances, predictive models of skin irritation following exposure, and new predictive genotoxicity and phototoxicity assays.
The company’s integrated, automated platform, its commitment to innovation and quality, and its location at Biocitech, a modern and secure technology park, are so many assets giving Oroxcell a real competitive advantage and confirming its advance and leadership role in reconciling people’s safety and compliance with the rule of the 3Rs (replace, refine and reduce) in the use of laboratory animals.
Operating at the interface between several different sectors of activity, Oroxcell gives players in each sector the benefit of its knowhow and its scientific and technological advances in different industrial fields through a process of cross-fertilization. By offering a range of services that stretches from innovation to development and includes international validation, industrialization and automated testing, Oroxcell gives a maximum number of clients access to its reliable and efficient state-of-the-art predictive technologies for evaluating the safety of medicines, cosmetics, chemicals and personal and home care products.
Among other things, Oroxcell contributed to securing the validation of the European Centre for the Validation of Alternative Methods (ECVAM) for RHE(R) epidermis reconstruction technology for combating skin irritation, which was subsequently approved by the European Commission and endorsed by the OECD (Organization for Economic Cooperation and Development). This technology, which has thus become a regulatory test, was developed by the cosmetics industry and is now also used by the chemical and pharmaceutical industries, as well as more broadly for evaluating the risks run by staff at their work stations.
Thanks to this comprehensive, integrated platform, Oroxcell now has more than 50 partners and customers in the life sciences and chemical industries around the world.
For more information, go to: http://www.oroxcell.com