Indena CDMO origin: Founded in 1921 by Carlo Boccaccio Inverni and Biagio Alberto Della Beffa and headquartered in Milan, Indena is a market leader in botanical derivatives for the pharmaceutical industry, with a know-how developed over a century.

One hundred year history is an important heritage, but it’s also the link towards the future. The four pillars on which Indena built its brand are: botanical expertise, quality, research and state of the art technologies and it is precisely from these features and a constant drive to innovate that back in 2010s the concepts of CDMO activities was defined.

Indena CDMO today

The long-term vision of the shareholders and of the management team was to capitalize on Indena core expertise gained in the field of naturally derived molecules and extend its reach focusing on technologies rather than the molecule origin. 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. Such services include the extraction, isolation and purification of natural molecules, manufacturing of HPAPI synthetic molecules, microbial fermentation and spray drying. The GMP plant, the HPAPI kilolabs and a PSD2 spray dryer from organic solvents are only the latest investments carried out in the last few years and underlines that the CDMO business area is one of the priorities for Indena’s strategic development.

Leveraging on its analytical and manufacturing expertise, Indena is positioning its services in a niche to produce complex molecules having a very high value and requiring strong expertise for R&D, industrialization, specific handling and production of HPAPI from early stage to commercialization.

The great differentiator as a reliable Western European producer is on Potent and Highly Potent API produced down to 20ng/m3 OEL, irrespective of their source, for which Indena is highly skilled and well equipped.

With the aim to increase and improve its services to customers, Indena recently doubled the lines able to manage OEB 5 products (2 instead of one) and the new one has reactors of  double capacity with respect to the old one (65 L instead of 30 L).

The combination of Indena’s expertise with state-of-the art facilities allows the company to deliver products and processes from small-scale GMP batches for clinical use (even in the gram scale) to large commercial supplies (up to hundreds kgs).

Nowadays, Indena typically undertakes the development of molecules (NCEs) in clinical phase 2 and support the development up to the launch and the commercial scale, offering a full range of process development and analytical development, regulatory support (preparation of the CMC section) activities in close collaboration to the sponsor of the project within a dedicated team.

Indena CDMO tomorrow

With the aim of providing customers with an increasing range of services, in the last 10 years the company has indeed been investing in the implementation of cutting-edge technologies; the plans for the future are to continue investing by further expanding the capacity for both NCEs and consolidated APIs. For 2023 and 2024, Indena has planned the expansion of the existing GMP plant, the installation of pilot scale hydrogenator and the expansion of the R&D lab for highly potent compounds.

New production plant for active pharmaceutical ingredient and industrial scale hydrogenator

In order to always meet and surpass its customer expectations, Indena has been working on expanding the offering of its GMP Pilot plant for active pharmaceutical ingredient, with an additional industrial scale facility equipped with reactors up to 10.000L. This intervention takes place with the aim of upgrading the system and exploiting Indena’s technologies at a larger scale and obtaining a state-of-the- art system in line with the best practice of the sector from every standpoint: engineering, safety, quality and scale.

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. Moreover, to face market requests in the most efficient and flexible way, Indena will be installing a 250L 10 Bar hydrogenator, which will be fully operational by the end of 2023. Together with the existing

20L hydrogenator, the new one will allow Indena to satisfy a wider demand for this kind of service.

New R&D development lab for Highly Potent API

Driven by the increased number of running projects, a major expansion of the R&D building has been planned to respond to customers’ demand; thanks to the highly-committed shareholders behind Indena, the decisions and the investments for expansions are taken and executed quickly. The expansion program includes the construction of a brand new R&D development laboratory of 400 m2 equipped with 12 fumehoods, 2 walk-in fumehoods, 1 laminar flow fumehood, 2 gloveboxes that will be able to host 15 R&D scientists. The project has been authorized in December 2022 and the new laboratory will be up and running by end-2023.