UNLOCK NEXT-LEVELHEALTH SOLUTIONSA NEW GENERATION OF CDMO SERVICESCustom Development & Manufacturing services have been one of Indena’s key
areas of expertise for more than 30 years now.
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 and industrialization, encompassing high containment
handling and production of HPAPIs from early stage to commercialization.
Indena’s goal 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 semi-synthetic
steps and for total-synthetic molecules. As a highly reliable Western European
API producer, Indena displays a key uniqueness on Highly Potent APIs down
to 20ng/m3 OEL, irrespective of their source, for which Indena 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.
Indena has been continually investingin know-how, personnel and equipment for
its CDMO services for many years.
Its most recent expansion program includes
the construction of a brand new 400 sqm
R&D laboratory equipped with 12 fumehoods,
2 walk-in fumehoods, 1 laminar flow fumehood,
2 gloveboxes able to host 15 R&D scientists.
This laboratory has been conceived and built
specifically to handle Highly Potent APIs
and will be up and running by mid-2024.

INDENA’S CDMO SERVICES:THE FORMULAFOR CLIENTS’ SUCCESS

Indena is also well supported by a strong regulatory
department that continuously interacts globally withthe most important national health authorities, such as
FDA, EMA, AIFA, ANSN, PDMA.

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.

The strengths of Indena’s CDMO offer are then supported
by manufacturing excellence programs, the highest
equipment standards and qualified human resources.

In order to always meet its clients’ expectations,
every year Indena invests in innovative technologies
and services. The quality and efficiency ofits equipment and facilities, however, are only halfof the story.
At Indena, it’s well understood that highly qualified,
motivated and trained technical staff, supported
by a corporate culture that is strongly oriented
toward quality and rigorous HSE policies, is essential
to ensure that operations run safely, seamlesslyand efficiently.

THE CURRENT CDMOSCENARIO AND INDENA’SSTRATEGY TO MEET
MARKET NEEDSThe increasing number of oncology NCEs
and antibody-drug conjugates, coupledwith 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 moleculardiversity 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 rom
1 mcg/m3 to 20 ng/m3 (with ongoing SMEPAC tests to reach 1 ng/m3).
Moreover, Indena has a fermentation department for carrying out living cells-based bio-transformationor secondary metabolite production, which can be exploited for the in-house production of toxins usedin 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.

SUSTAINABILITY:
A CONCRETE COMMITMENT
Indena constantly works to drive progress towards the UN’s Sustainable Development Goals,
aiming to prioritize sustainability in every phase – from raw material sourcing to production
and marketing – with a focus on environmental impact, use of renewable energies and a tangible
contribution to a more circular economy.
In particular, climate change is one of the most urgent sustainability challenges that people,governments and companies have to face. Recognizing responsible use of energy as a key factor
in this context, Indena has always been oriented and committed to reducing fossil fuelconsumption by saving energy as well as by achieving high levels of energy self-production.
Plant management – starting with Indena’s most important site, located in Settala near Milan in Italy,
where the company’s CDMO activities are carried out – plays a pivotal role in this.

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 Indena’s Europeanfactories are certified according to the ISO 14001 Environmental Management System
and ISO 45001 Occupational Health and Safety Management System.
All these strategic actions taken in favor of sustainability also make Indena fully reliable
in terms of business continuity, strengthening the foundations for long-term, solid partnerships
with clients.

To f i n d o u t m o r e :indena.com

Contact: cdmo@indena.com