For years, custom services have been a key focus and have become a strategic contributor to Indena's success. In recent years, the company has devoted both time and effort to being a top-tier CDMO by opening new suites, installing new equipment and — by creating a separate division to take care of custom development projects — investing in dedicated R&D resources.
It’s not just machinery that adds value for Indena’s customers, though, it’s also the highly skilled operators who are supported by colleagues in functions such as R&D, Industrial Operations, HSE and Business Development. In line with company policy, it’s a relationship of mutual respect that encourages customers to trust Indena to develop and produce their new synthetic molecule or natural derivative, an asset that could define the destiny of the entire company.
Indena’s focus in recent years has been on innovative molecules, particularly highly potent active pharmaceutical ingredients (HPAPIs) obtained by synthesis, fermentation or natural origin, which require high containment facilities. Currently, the company is equipped to handle substances with an Occupational Exposure Limit (OEL) of 20 ng/m3, including toxin-based payloads for antibody-drug conjugates (ADCs).
Another area of expertise is the preformulation of poorly soluble APIs (using spray drying and proprietary phospholipid-based technology) and naturally derived complex molecules.
The combination of multiple highly specialised technologies at one site facilitates supply chain optimisation, enabling, for example, the synthesis of an API, subsequent spray drying, the addition of excipients to obtain a drug product intermediate, the contained fermentation of an oncological API and downstream processing.
The availability of multiple and complementary areas of expertise, in a company such as Indena, represents an efficient way to secure, optimise and streamline the entire pharma supply chain.
Indena's new pilot plant
As for equipment, in the last three years, Indena has developed some very innovative suites at its main manufacturing site in Settala (Milan, Italy), including a new HPAPI kilo lab and a pilot pharmaceutical plant with a GEA spray dryer. Moreover, the company has upgraded its fermentation plant for multipurpose use.
Indena’s manufacturing site had long been equipped with large-scale isolators for the commercial production of semisynthetic HPAPIs with an OEL of 800 ng/m3, which have been upgraded to handle even more toxic compounds (natural and synthetic) with an OEL in the range of 150 ng/m3.
These large-scale suites have been complemented with an additional kilo lab (LK2), which is dedicated to handling extremely potent compounds (OEL = 20 ng/m3).
In addition, Indena also opened a brand-new pharmaceutical pilot suite for the GMP production of clinical batches, the manufacture of non-potent intermediates and commercial batches requiring yearly productions in the range of tens of kilos.
And, as a natural extension of its existing capabilities, Indena installed a GEA PSD-2 spray dryer to complement the large-scale machine that has been working with organic solvents since the early 1990s. The PSD-2 is a medium sized plant for clinical and commercial needs that can handle Class 2 organic solvents and is designed to process APIs and preformulated APIs with an OEL of ≥10 µg/m3.
To further increase Indena’s services customers, an existing fermentation plant (once dedicated to a proprietary biotransformation technique) has been upgraded to a multipurpose facility (which features 1000–20,000 L industrial equipment, a 10 L laboratory and 100/150 L pilot-scale fermenters). Its specialty application is the ability to ferment toxic compounds, making it a valuable complement to the existing HPAPI suites where downstream processing takes place.
In a scenario in which approximately 56% of pharma and biotech companies outsource the clinical stage synthesis of small molecules, and 33% use CDMOs for commercial production, the strategic decisions and investments made by Indena will position the company as an authoritative supplier of contract services in the industry.