Industry Press Releases

Menarini Expands its Capabilities for Antibody Drug Conjugate (ADC) Projects

Thursday, Jun 08, 2017

Menarini is highly and strategically committed to growing its portfolio of oncological projects. To anticipate the increasing needs of such projects, Menarini has recently made important investments to expand its manufacturing capabilities for oncological drugs by setting up new, dedicated facilities in Pisa and Berlin.

In Pisa, advanced manufacturing suites (about 250 m2) have been built for the production of clinical batches of highly potent antitumoral compounds. The new facility will  manufacture both small molecules and biological macromolecules such as antibody-drug conjugates (ADC), obtained through the conjugation of monoclonal antibodies to potent toxins. These new suites have been built in compliance with the highest standards of containment for the safety of workers and the environment, and are equipped with last generation reactors, ultrafiltration systems and chromatographic apparatuses. At this time, the new facilities will manufacture clinical batches of MEN1309/OBT076. This ADC, which is part of the partnership agreement between Menarini and Oxford Bio Therapeutics (OBT), is being developed for the treatment of solid and hematological tumors.

In the research centre for pharmaceutical development in Berlin, a dedicated building (ca. 230 m2) has been built for packaging, labeling, storage and distribution of clinical trial supplies (CTS) of anti-tumoral compounds, including ADCs. This new facility meets the highest safety standards, is equipped with state of the art systems, and has already received the authorization from the German authority. In the forthcoming months this facility will manufacture and store the CTS for the ADC MEN 1309/OBT076, which will be distributed to clinical trial centers.

These new achievements are part of the strong commitment of Menarini to oncology with scientifically advanced and innovative investigational compounds, fully supported by manufacturing capabilities of the highest technological level.

About the Menarini Group

Menarini Group is an Italian pharmaceutical company, 19th in Europe out of 5,541 companies, and 39th company in the world out of 21,317 companies, with a turnover of more than 3.4 billion Euro and more than 16,600 employees. The Menarini Group has always pursued two strategic objectives: research and internationalization and is present in the most important therapeutic areas with products for cardiology, gastroenterology, pneumology, infectious diseases, diabetology, inflammation, and analgesia. Menarini is also committed to oncology, with four new investigational drugs, including two monoclonal antibodies and two small chemical entities, in development for the treatment of a variety of hematological and solid tumors.



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