40 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 In 2025, Indena completed several facility upgrades that enable it to make a further leap in the quality, versatility, and reliability of its CDMO activities for its partners. Specifically, these enhancements concern the GMP Plant at its main production facility located in Settala, near Milan, Italy. The GMP Plant has been equipped with a new, state-of-the-art filter dryer for highly potent molecules. This equipment allows for entirely new productions and thus enables Indena to meet even more complex and sophisticated client requests, always under conditions of total safety for operators. This plant has been approved by AIFA and is now fully operational. This highly specialized technology is crucial for the production of complex molecules, an area where Indena is already recognized as one of the leading international players. The GMP plant is being expanded in some steps starting 2024, and this expansion allowed the plant to enlarge the capacity of reactions / chemical synthesis up to 10 times the original capacity and produce on larger scale HPAPIs obtained both by synthesis and purification (small molecules to OEB5). The plant can handle a wide range of synthetic reaction within a temperature range from -80 °C to +150 °C. It includes 2 x 1000 L reactors in stainless steel, 400 and 1000 L glass lined reactors, 250 L hastelloy reactor, 500 L chromatographic column and an hastelloy centrifuge and can be also used for small scale commercial productions. By 2025, the installation of 3,000-liter enameled reactors will also be completed, which will enable large-scale production of APIs and HPAPIs in addition to the smaller-scale productions already carried out by Indena. The technologies already existing in the GMP Plant for the chemical synthesis and purification of APIs and HPAPIs include centrifugation under containment (reverse bag centrifuge), reactor loading under containment (glove boxes), isolation and drying with filter dryers featuring surface areas of 0.2, 0.4, 1 m², and purification through 2,000 liter chromatographic columns operating at a pressure up to 9 bars. For hydrogenation, Indena has recently acquired a Biazzi hydrogenator, able to work up to 10 barg. Regarding production plants, another point of strength of Indena is the kilolab LK2 plant at the Settala site. Started in 2024, LK2 has been further enhanced with equipment that allows Indena to work with highly potent molecules, guaranteeing an OEL of 1 ng/m³. This is a very significant development, considering that the previous containment level for highly potent compounds was 20 ng/m³. The site is currently equipped with a freeze dryer dimensioned for the supply of clinical batches of super-potent compounds. INDENA
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