Indena, an organisation specialising In CDMO services, will showcase its custom services at this year’s DCAT 2024. The company 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.
Leveraging on its analytical, development and manufacturing capabilities, Indena positions its services in a high added value segment, producing complex molecules requiring both novel technologies and significant expertise in R&D, analytics and industrialisation, encompassing high containment handling and production of HPAPIs from early stage to commercialisation.
“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.
“Indena endeavours to produce highly potent APIs down to 1 ng/m3 OEL, irrespective of their source.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 personalised medicine, is shaping the demand for CDMO services.
The HPAPI market is undergoing a shift toward NCEs characterised by higher potency, growing molecular diversity and segmentation for specific populations.
Within its long-term strategy, Indena has always tried to keep ahead of the curve by timely investment in specialised containment facilities that guarantee that both employees and the external environment are safe from exposure, capitalising 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.
All of Indena’s European sites are fitted with photovoltaic panels, as well as being ISO 14001 Environmental Management System and ISO 45001 Occupational health and safety management system certified.
All the actions taken in favour 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.
