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GMP services

areta works at all stages of development of biodrugs and products for innovative therapies, offering its services in the field of process optimization, manufacturing, aseptic filling, development of new analytical methods, quality control testing, batch release and stability studies, while also offering highly-qualified consultancy for quality and regulatory requirements.

areta offers its customers a GMP facility, authorized by AIFA, to produce and release biopharmaceuticals for clinical trials. In 2004, areta has 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 biodrug types (cells, proteins, immunological products, plasmids for DNA-based vaccines), as well as execute aseptic filling, final lyophilization and release of finished product.

The expertise of GMP's staff is founded on a consolidated experience in the field of research and development of innovative pharmaceuticals, and on constant training as required by the internal Quality System. This particular feature makes areta a dynamic partner for the development of new molecules, from process development to support of clinical trials.

The facilities and the acquired know-how allow areta to simultaneously manage projects which are very different one from the other, both in terms of product categories and quantity of the finished product. The processes provided are simple, GMP compliant, highly personalized and easily scalable, according to the customer needs.

The Gerenzano facility has recently been expanded and renewed. It now covers a classified area of 500 m2, sub-divided in D, C, and A/B classes. Each class is supported by independent filtering and air expulsion systems. The facility is also equipped with 150 m2 of QC (Quality Control) laboratories. Two separate production zones are available for products generated in mammalian and bacterial cells.

The 200 m2 areta’s facility in Siena was completed in 2009. It is equipped with D and C classes and devoted to production of recombinant proteins and DNA.

 

 
 
 

areta international S.r.l | via R. Lepetit, 34 | 21040 Gerenzano (VA) Italy
Tel: +39 02 96474804 | Fax: +39 02 96474800 | P.iva: 12914940155 | Share capital € 709.249,00