In a challenging CDMO framework, Indena has acquired the experience and the equipment to handle high potent NCEs and commercial products.
Moreover, the company is able to ensure business continuity, thanks to 100 years of expertise and solid supply chain, its financial solidity and an ownership that has lasted for one hundred years. Two more pillars of Indena’s custom services are a continuous search for innovation, which allows the company to design science based breakthrough solutions for the clients, and its commitment to sustainability.
Leveraging on its analytical and manufacturing expertise, Indena positions its services in a niche to produce complex molecules having a very high value and requiring strong expertise for R&D, industrialisation, high containment handling and production of HPAPI from early stage to commercialisation.
Indena’s goal is to offer to its customers the possibility of carrying out synthetic processes in a wide range of conditions for both natural molecules that requires semisynthetic steps, and for total-synthetic molecules. The great differentiator as a reliable Western European producer is on Highly Potent API produced down to 20ng/m3 OEL, irrespective of their source, for which Indena is highly skilled and well equipped.
Indena has been investing in expertise and equipment for its CDMO services for years. The most recent expansion program includes the construction of a brand new R&D development laboratory of 400m2 equipped with 12 fumehoods, two walk-in fumehoods, one laminar flow fumehood, two gloveboxes that will be able to host 15 R&D scientists. This laboratory has been built specifically to handle Highly Potent API.
The project will be up and running by mid-2024. Custom services are a key area of Indena’s expertise since 1990s. This business area has been entered mainly to answer to US clients’ needs, both solving complex problems through smart and innovative solutions and capitalising Indena’s expertise in handling HPAPI.
The decision of the shareholders and the management team was to use Indena’s expertise in the field of natural derivative molecules focusing on the completion of pharmaceutical production for third parties (CDMO). Thanks to the work done so far, today Indena offers a full range of manufacturing capabilities for active pharmaceutical ingredients and supporting services, which allow the company to be a fully integrated partner for drug substance.
As said, Indena can put a dedicated CDMO division, supported by a strong R&D team, at our partners’ service, and promptly implement custom solutions for specific projects requiring dedicated equipment. Nowadays, Indena manufactures 12 commercial HPAPIs: fully synthetic, semi-synthetic and fermentation molecules.
Each substance within Indena is assigned an occupational exposure level (OEL) and allocated to the proper production line according to the required handling and containment rules. At its Settala facility (Italy), Indena can handle HPAPIs with an OEL from 20ng/m3 to 1mcg/m3.
On top of its focus on HPAPIs, Indena has leading expertise in the pre-formulation of poorly soluble APIs. The combination of multiple, highly specialised technologies in one site allows the company to optimise the supply chain: for example, Indena is able to carry out the synthesis of an API and the subsequent spray drying step using organic solvents, also in the presence of excipients, to obtain a pre-formulated drug product.
Indena is equipped with development and commercial scale spray dryers to provide clinical and commercial volumes. These activities are fully supported by the analytical team.
Moreover, Indena has a fermentation department to carry out living cells-based bio-transformation or secondary metabolites production. 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 fermentation HPAPI development.
Indena has also a strong commitment to sustainability. It has always been oriented and committed to reducing fossil fuel consumption and use, saving energy, and achieving high levels of energy self-production. Such commitment is achieved mainly thanks to the company’s plant management, starting from its most important one, located at its site in Settala near Milan in Italy, where Indena’s CDMO activities are implemented.
Another important action for sustainability is the use of renewable energy. Indena is equipping all its European sites with state-of-the-art photovoltaic panels. All the Indena’s European factories are also certified ISO 14001 Environmental Management System and ISO 45001 Occupational Health and Safety Management System.
