ARETA INTERNATIONAL S.r.l. (ARETAINT)
- Last Updated: 10 September 2013
Competences: ARETA International (ARETAINT) is a biotech company dedicated to the contract development and manufacturing of innovative biological drugs and advanced therapy medicinal products. ARETA has a consolidated ten-year experience in the field of cell culture and biological for clinical, preclinical and R&D studies. The strong commitment towards quality, the multipurpose production facility and the GMP authorization provided by AIFA (Italian Medicines Agency), in compliance with EU requirements, to manufacture and release drug batches for clinical trials, make ARETA the reliable partner for the development of innovative therapies. The business model of ARETA is based on R&D and GMP contract manufacturing. ARETA has been investing an important part of its budget in human resources and funded research projects (EU-funded or national), acquiring a deep and updated know-how and being always in contact with the most innovative technologies in the field. The interaction between different expertises makes ARETA flexible in the management of customized research and development projects. ARETA offers to its partners a GMP facility, authorized by AIFA, to produce and release biopharmaceuticals for clinical trials. Since 2004, ARETA have been authorized to produce cells for cell therapy and in 2009 the authorization was extended to become truly multipurpose, enabling the company to manufacture different types of biodrugs (cells, proteins, immunological products, plasmids for DNA-based vaccines), as well as execute aseptic filling, final lyophilisation and release of finished product. ARETA International provides also safety and QC tests, biochemical and biological characterization, stability studies according ICH and final batch release services. The main activities of the R&D laboratories are the pre-GMP process development for recombinant proteins, the generation and production of new monoclonal antibodies and the set up and development of biological tests.
Material resources: ARETA International is located in Gerenzano (VA) within the facility of Fondazione Istituto Insubrico di Ricerca per la Vita. ARETA is constituted by a GMP high containment and classified production plant for tailor made supply of bio-drugs and research laboratories for the generation of ad hoc tools for R&D and Diagnostics (Mabs, rec proteins, cell). The GMP plant is equipped with four independent class B rooms with laminar flow biohazard cabinets and a liophilizer. Other class C production laboratories, a purification class C room and separated high-containement laboratories are avaialble at the facility.
Role: ARETA will provide specific skills and technical expertise in WP1 on experimental tasks concerning the generation of new immunological tools and subsequent set up of ELISA test for quantification of fish proteins in biological samples. Areta will be able to generate antibodies against the selected proteins, develop a protocol and perform a feasibility study for the detection of the proteins of interest.
Staff members’ profile:
- Luigi Cavenaghi, Qualified Person of ARETA International, is author and co-author of two patents. He has more than forty years industrial experienced in Biotechnology R&D and Quality Control fields. He brings to ARETA International’s projects his expertise in biotechnology, analytical development of biotech molecules and production of controlled and validated batches for clinical and preclinical studies.
- Maria Luisa Nolli, has more than 15 years industrial experience as a scientist and team leader in the field of Biotechnology and she is author or co-author of nine patents and about 50 papers.Her expertise in process development of biotech molecules and production of controlled and validated lots for preclinical studies provides the best qualifications about her contribution to the project.