INDENA Since the 1990s, Indena has acted as a strategic partner in CDMO services, going beyond the mere client-supplier relationship, with full commitment to developing new HPAPIs and APIs, from early clinical stages to commercial-scale manufacturing. Indena’s technological and research capacity, together, represents a unique and distinctive case in the CDMO operator sector. Its leadership and excellence in custom services lie in its commitment to continuously investing in new and updated equipment and technologies, as well as on talented researchers. The company’s goal is to offer its customers the possibility of carrying out synthetic processes in a wide range of conditions, both for naturallyderived molecules (from botanical sources or from microbial fermentation) requiring semi-synthetic steps and for total-synthetic molecules. Leveraging on its analytical, development and manufacturing capabilities, Indena positions its services in a high added value segment, producing complex molecules requiring both leading technologies and significant expertise in R&D and industrialisation. As a highly reliable Western European API producer, Indena displays a key uniqueness on Highly Potent APIs down to 1ng/m3 OEL, irrespective of their source, for which Indena is highly skilled and well-equipped. Nowadays, Indena manufactures ten commercial HPAPIs and 12 clinical phase HPAPIs: fully synthetic, semi-synthetic and fermentation molecules. This is now one of the company’s core areas of expertise. Each substance within Indena is assigned an Occupational Exposure Level and allocated to the proper production line according to the required handling and containment rules. At the Settala facility, Indena can handle HPAPIs with an OEL starting from 1 ng/m3. Indena’s expertise includes payloads for Antibody Drug Conjugates (ADCs), with a backward integration on fermentation for toxins requiring this step and freeze-drying ability in high containment. As for the equipment, since 2019 in Indena’s main production site is a GMP plant that can handle a wide range of synthetic reactions within a temperature ranges of -80 °C/+150 °C. The plant includes two 1000 L reactors in stainless steel, 400 and 1000 L glass lined reactors, 250 L hastelloy reactor, 500 L chromatographic column and a hastelloy centrifuge, and can be also used for small-scale commercial productions. TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 34
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