41 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 INDENA and commercialize many higher volume APIs and HPAPIs. Moreover, Indena has a fermentation department for carrying out living cells-based bio-transformation or secondary metabolite production, which can be exploited for the in-house production of toxins used in ADCs payload, guaranteeing an integrated and independent supply chain. Indena masters GMP microbial fermentation and bio-transformation, and thanks to the availability of high containment lines for the downstream phase, it is the ideal partner for precision fermentation HPAPI development. Actually, the market for HPAPIs is growing due to the increasing prevalence of complex diseases and the development of targeted therapies. It has been estimated that HPAPIs may now account for more than 30% of the drug development pipeline. Some of the conditions that use HPAPIs include: cancers, autoimmune disorders, infectious diseases and rare diseases. And Indena is at the forefront in addressing the last market challenges. Among these are molecules that increasingly act in a targeted manner on specific conditions, aligning with the principles of precision medicine. In the oncology sector, ADCs represent the latest frontier, and Indena is actively engaged through its research and development activities to produce payload linkers for ADCs (Antibody drug conjugates) on a large scale. These engineered molecules combine the specificity of monoclonal antibodies with the potent cytotoxicity of chemotherapeutic drugs, offering a more precise and potentially less toxic approach. The uniqueness of Indena’s LK2 facility lies in the fact that both the laboratories and the production plant are located in the same building. This allows for great process efficiency while ensuring the ability to handle highly potent molecules in complete safety. Looking ahead, two further production lines will be added, always designed for research and processing of highly potent molecules. The first, which will be operational in 2026, will have a 65-liter reactor and a 100-liter reactor, both inserted inside glove boxes, and a 40 cm diameter filter dryer in Hastelloy C22. This configuration allows for filtration and drying under dynamic conditions, and the new equipment integrates with the existing systems in the plant. A second production 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. Idnena’s most recent expansion program also includes the construction of a state-of-the-art new 400 sqm R&D laboratory equipped with high performances and high containment fumehoods (12 bench-top fumehoods and 2 walk-in fumehoods), 1 laminar flow fumehood, 2 gloveboxes able to host a large team of scientists working at Indena. Additionally, a new industrial GMP line with reactors up to 10.000L will allow the company to produce
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