In 2025, Indena significantly upgraded its facilities, marking a substantial advancement in the quality, versatility, and reliability of its CDMO services for partners. These strategic improvements primarily focus on the GMP Plant at its main production site in Settala, near Milan, Italy. The GMP Plant now features a cutting-edge filter dryer for highly potent molecules, unlocking novel production capabilities and addressing complex client demands while maintaining the highest safety standards. This AIFA-approved facility is fully operational, underscoring Indena’s leadership in high-potency molecule synthesis.
The GMP plant is undergoing a multi-phase expansion initiated in 2024, augmenting its reaction/chemical synthesis capacity tenfold. This enables larger-scale production of HPAPIs (Highly Potent Active Pharmaceutical Ingredients) from synthesis and purification (small molecules up to OEB5). The plant handles diverse synthetic reactions from -80 °C to +150 °C, with infrastructure including 1000 L stainless steel reactors, glass-lined reactors (400 L, 1000 L), a 250 L Hastelloy reactor, a 500 L chromatographic column, and a Hastelloy centrifuge. This setup also supports small-scale commercial productions. By 2025, 3,000-liter enameled reactors will be installed, further expanding large-scale API and HPAPI production.
Existing GMP Plant technologies for API and HPAPI synthesis and purification include contained centrifugation (reverse bag centrifuge), contained reactor loading (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 recently acquired a Biazzi hydrogenator, capable of operating up to 10 barg.
Beyond the GMP Plant, Indena’s kilolab LK2 plant at the Settala site is another cornerstone. Since 2024, LK2 has been enhanced for safe handling of highly potent molecules, guaranteeing an Occupational Exposure Limit (OEL) of 1 ng/m³, a significant improvement from the previous 20 ng/m³. Following the successful integration of a small freeze dryer for HPAPI lyophilization (1 ng/m³ OEL), a larger-scale commercial freeze-drying line will be installed in 2026.
A key advantage of Indena’s LK2 facility is the co-location of laboratories and the production plant within the same building, fostering exceptional process efficiency and secure handling of highly potent molecules. Two additional production lines are planned for highly potent molecules. The first, operational in 2026, will feature 65-liter and 100-liter reactors within glove boxes, and a 40 cm diameter Hastelloy C22 filter dryer, enabling dynamic filtration and drying. A second line includes a freeze dryer with a surface area of 1 m² with a capacity of 10 kg of ice in 24 hours, also located inside a glove box.
The same glovebox will be equipped with a spray dryer inside the glove boxes, which will allow work on HPAPIs, guaranteeing an OEL of less than 1 ng/m³.
Indena’s expansion also includes a new 400 sqm R&D laboratory with high-performance, high-containment fume hoods (12 bench-top, 2 walk-in), a laminar flow fume hood, and two glove boxes, providing ample space for scientists. A new industrial GMP line with reactors up to 10,000 L will enable higher-volume API and HPAPI production. Indena’s fermentation department for cell-based biotransformation or secondary metabolite production can be leveraged for in-house production of toxins for ADC payloads, ensuring an integrated supply chain. Indena’s expertise in GMP microbial fermentation and biotransformation, coupled with high-containment lines, positions it as an ideal partner for precision fermentation HPAPI development.
The HPAPI market is growing significantly due to complex diseases and targeted therapies, with HPAPIs now constituting over 30% of the drug development pipeline. These compounds treat cancers, autoimmune disorders, infectious diseases, and rare diseases. Indena leads in addressing these market challenges, particularly with targeted molecules aligning with precision medicine. In oncology, ADCs are the latest frontier, and Indena actively researches and develops large-scale payload linkers for ADCs. These engineered molecules combine monoclonal antibody specificity with chemotherapeutic drug cytotoxicity for a more precise and less toxic approach.
The quality of Indena’s CDMO services is paramount, driven by its dedicated teams where professional experience merges with the enthusiasm of young scientists. Indena recognizes that highly qualified, motivated, and trained technical staff, supported by a corporate culture committed to quality and stringent HSE policies, is essential for safe, seamless, and efficient operations.
Since the 1990s, Indena has been a strategic CDMO partner, fully committed to developing new HPAPIs and APIs from early clinical stages to commercial manufacturing. Indena’s combined technological prowess and research capabilities offer a unique model in the CDMO sector. Its leadership stems from continuous investment in equipment, technologies, and talented researchers. The company aims to offer clients synthetic processes across diverse conditions for both naturally derived and total-synthetic molecules.
Leveraging its analytical, development, and manufacturing strengths, Indena positions its services in a high-value segment, producing complex molecules requiring advanced technologies and significant R&D and industrialization expertise. As a reliable Western European API producer, Indena uniquely handles Highly Potent APIs down to 1 ng/m³ OEL, regardless of source, an area where it is exceptionally skilled.
Currently, Indena manufactures 10 commercial and 12 clinical-phase HPAPIs (fully synthetic, semi-synthetic, and fermentation-derived), a core expertise. Each substance is assigned an Occupational Exposure Level and allocated to the appropriate production line based on handling and containment protocols.
