Indena at DCAT 2024: a new generation of CDMO services

Milan, 18^th March 2024 – In CDMO services, Indena acts as a strategic partner, going beyond the mere client/supplier relationship, with full commitment to developing new HPAPIs and APIs, from early clinical stages to commercial-scale manufacturing.

With this mindset, Indena approaches DCAT 2024, where the CDMO team from the Italian company is ready to meet pharma and biotech enterprises offering a full range of reliable and innovative custom services.

Leveraging on its analytical, development and manufacturing capabilities, Indena positions its services in a high added value segment, producing complex molecules requiring both leading technologies and significant expertise in R&D, analytics and industrialization, encompassing high containment handling and production of HPAPIs from early stage to commercialization.

“Indena’s positioning is to offer its customers the possibility of carrying out synthetic processes in a wide range of conditions, both for naturally derived molecules (from botanical sources or from microbial fermentation) requiring semisynthetic steps and for total-synthetic molecules - explains Bernard Vianes, Global CDMO Director at Indena -. As a highly reliable Western European API producer, Indena displays a key uniqueness on Highly Potent APIs down to 1 ng/m³ OEL, irrespective of their source, for which the company is highly skilled and well equipped. This expertise includes payloads for ADCs, with a backward integration on fermentation for toxins requiring this step and freeze-drying ability in high containment”.

The increasing number of oncology NCEs and antibody-drug conjugates under development, coupled with a growing focus on personalized medicine, is shaping the demand for CDMO services. The HPAPI market is undergoing a shift toward NCEs characterized by higher potency, growing molecular diversity and segmentation for specific populations.

As shown by its long story and expertise, and unlike newcomers in the field, Indena can count on extensive know-how in safely handling HPAPIs, complemented by state-of-the-art equipment and installations.

Within its long-term strategy, Indena has kept ahead of the curve by timely investment in specialized containment facilities that guarantee that both employees and the external environment are safe from exposure, capitalizing on more than 30 years of know-how in high containment.

Nowadays Indena manufactures 12 commercial HPAPIs: fully synthetic, semi-synthetic and fermentation molecules. This is now one of the company’s core areas of expertise. Each substance within Indena is assigned an Occupational Exposure Level and allocated to the proper production line according to the required handling and containment rules. At the Settala facility, Indena can handle HPAPIs with an OEL from 1 mcg/m³ to 1 ng/m³.

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 fermentation HPAPI development.

Climate change is one of the most urgent sustainability challenges that people, governments and companies have to face, and this involves a responsible use of energy. Indena has always been oriented and committed to reducing fossil fuel consumption and use, saving energy and achieving high levels of energy self-production.  This commitment is mainly achieved thanks to the company’s plant management, starting with its most important plant, located at Settala near Milan in Italy, where Indena’s CDMO activities are conducted.

Another important action for sustainability is the use of renewable energy, and Indena is equipping all its European sites with state-of-the-art photovoltaic panels. Moreover, all of the Indena’s European factories are ISO 14001 Environmental Management System and ISO 45001 Occupational health and safety management system certified.

All the actions taken in favor of sustainability also enable Indena to be fully reliable in terms of business continuity, and therefore to be a reliable partner for all its clients.