Menarini has recently made investments to expand its manufacturing capabilities for oncological drugs by setting up new, dedicated facilities in Pisa and Berlin.
In Pisa, advanced manufacturing suites have been built for the production of clinical batches of highly potent antitumoral compounds. The new facility will manufacture small molecules and biological macromolecules such as antibody-drug conjugates (ADC), obtained through the conjugation of monoclonal antibodies to potent toxins. The new suites 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 center for pharmaceutical development in Berlin, a dedicated building 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.