In vitro safety and efficacy tests for the characterization of active pharmaceutical ingredients (APIs) and other compounds.
Spanish biotechnological research organization offers in vitro models to test safety and efficacy of compounds using eukaryotic mammalian and parasitic cell cultures that can be grown under static or shaking conditions in carbon dioxide thermostatized incubators. Some cell lines include fluorescent reporter genes that can be easily monitored to measure cell viability. This service is offered under service or research cooperation agreement.
The partner sought is an academic, research organization or company in the field of activity of pharmaceuticals, which are interested in carrying out in vitro trials for the screening of compounds in terms of safety and efficacy under a service or a research cooperation agreement.
Spanish biotechnological research institute, founded in 1993, has experience in cellular and molecular biology and microbial biotechnology. The institute's remarkable scientific profile (more than 80 public funded research projects, 15 of them under European Union framework programmes) is underpinned by the expertise of its staff in cellular and molecular biology, omics tools and bioinformatics. The institution keeps close links with industrial research and innovation in the regional and national areas. The research organization, with broad experience in microbiology, cellular and molecular biology and biotechnology, and strong background as participant in European projects from different calls, offers its expertise in conducting in vitro safety (cytotoxicity, mutagenicity and genotoxicity) and efficacy (antibiotic, antifungal, antiparasitic, antitumoral, etc) tests using eukaryotic mammalian and parasitic (as Leishmania ) cells in close collaboration with the department of biomedical sciences of a Spanish university. The offered in vitro tests are of strategic great value for the development of potential drugs in the preclinical testing phase. The desired cooperation type would be as a service agreement with biotechnological entities interested in validating its models with in vitro test. The research institute want be part of a consortium built up for any European call, where they could participate for conducting in vitro safety and efficacy tests in the development of novel drugs.
Advantages and innovations
These analyses require specific know-how and high degree of expertise, which have been acquired by the researchers for several years. Safety is assessed in mammal cell lines (vero, raw macrophages, hepG2 cells, etc.), where cytotoxicity is measured using methods included in OECD guidelines, such as alamar blue or (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) . Efficacy is assessed in different cell types, including bacteria, fungi and parasites. In this specific case, when required, they can use engineered parasites with fluorescent reporter genes, which can be easily monitored to measure cell viability. This is precisely the main innovative aspect of the service, the use of Leishmania parasites, which have been genetically modified to make them fluorescent and easily monitored to measure cell viability.
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