INDENA SPOTLIGHTS EXPANDED CAPABILITIES AND INNOVATION AT CPHI 2025
FEATURING: NEXT – GENERATION TECHNOLOGIES FOR PHARMA
MANUFACTURING, BREAKTHROUGH APIs AND A KEY ADC PROJECT
Milan, 28th October, 2025 – Indena announces its participation at CPHI 2025, taking place from 28th to
30th October at Messe Frankfurt, Germany. The company is pleased to invite customers, prospects,
and industry experts at Booth 5.0C102 to discover its latest advancements. Indena will highlight
significant upgrades to its main Italian manufacturing plant with new, groundbreaking equipment;
present some of its highly effective and innovative APIs; and announce its strategic cooperation with
TCG GreenChem for the development of Antibody-Drug Conjugates (ADCs).
“We are delighted to once again be a prominent participant at CPHI 2025, one of the most notable
events in the pharmaceutical industry. This year CPHI provides an invaluable opportunity to share with
all our stakeholders our latest enhancements, highlighting our specialized facilities – says Daniele
Giavini Managing Director of Indena S.p.A. –. We have made significant investments to equip our
production sites with efficient and advanced technologies, reinforcing our leadership in CDMO services.
For example, our main facility in Settala, Milan, is now equipped with a filter dryer for highly potent
molecules, and these upgraded plants are where we develop and produce also our well known and
long lasting taxanes. Moreover, we are displaying two recent botanically-derived APIs, Squalene,
derived from Amaranthus plants, and Cytisine, sourced from Laburnum anagyroides Medik plants:
crafted specifically for the pharmaceutical industry, these products exemplify our unwavering
commitment to the highest standards of quality and sustainability.
We look forward to engaging with attendees and discussing how Indena continues to drive innovation
and excellence in the pharmaceutical sector.”
INDENA NEWS AT CPHI 2025
In 2025, Indena significantly upgraded its facilities, as part of a continuous expansion plan, marking a
substantial advancement in the scope, versatility, and reliability of its CDMO services for partners.
These strategic improvements primarily focused on its main production site in Settala, near Milan, Italy.
The GMP synthetic plant now features an innovative filter dryer for highly potent molecules, unlocking
novel production capabilities and addressing complex client demands while maintaining the highest
safety standards. This AIFA-approved facility is fully operational, underscoring Indena’s leadership in
high-potency molecule synthesis.
The GMP plant’s expansion enables large-scale production of HPAPIs (Highly Potent Active
Pharmaceutical Ingredients) from synthesis and purification (small molecules up to OEB5). The plant
handles diverse synthetic reactions from -80 °C to +150 °C, with infrastructure including stainless steel
reactors with capacities up to 10,000 liters, glass-lined reactors up to 3,000 liters, Hastelloy reactors up
to 1,200 liters, a 500-liter chromatographic column, and a Hastelloy centrifuge. This setup also supports
small-scale commercial productions. For hydrogenation, Indena recently installed a 250-liter. Biazzi
hydrogenator, capable of operating up to 10 barg.
Beyond the GMP Plant, Indena’s HPAPI kilolabs at the Settala site are another cornerstone. The
kilolabs allow safe handling of highly potent molecules, guaranteeing an Occupational Exposure Limit
(OEL) of 1 ng/m³. Following the successful integration of a small freeze dryer for HPAPI lyophilization (1
ng/m³ OEL), a larger-scale commercial freeze-drying line is under installation.
“A key advantage of Indena’s kilolabs facility is the co-location of laboratories and the production plant
within the same building, fostering exceptional process efficiency and secure handling of highly potent
molecules – explains Stefano Togni Chief Commercial Officer of Indena S.p.A. – Two additional
production lines are planned for highly potent molecules. The first, operational in 2026, will feature 65
liter and 100-liter reactors within glove boxes, and a 40 cm diameter Hastelloy C22 filter dryer, enabling
dynamic filtration and drying. A second line includes a freeze dryer with a surface area of 1 m² with a
capacity of 10 kg of ice in 24 hours, also located inside a glove box. The same glovebox will also
feature a spray dryer, to allow working on HPAPIs, guaranteeing an OEL of less than 1 ng/m³”.
Indena’s expansion also includes a new 400 sqm R&D laboratory with high-performance, high
containment fume hoods (12 bench-top, 2 walk-in), a laminar flow fume hood, and two glove boxes,
providing ample space for scientists. A new industrial GMP line with reactors up to 10,000 L will enable
higher-volume API and HPAPI production. Indena’s fermentation department for cell-based
biotransformation or secondary metabolite production can be leveraged for in-house production of
toxins for ADC payloads, ensuring an integrated supply chain. Indena’s expertise in GMP microbial
fermentation and biotransformation, coupled with high-containment lines, positions it as an ideal partner
for precision fermentation HPAPI development.
EXPLORING INDENA’S LEADING PRODUCT SOLUTIONS AT CPHI 2025
Another key area Indena will address is its specialized capabilities in the sustainable and reliable
manufacturing of taxanes, essential compounds for cancer therapies: Indena has been a pioneer in the
selection and cultivation of highly productive yew breeds and has devised a semi-synthetic proprietary
process allowing the obtainment of paclitaxel, docetaxel and cabazitaxel, overcoming yew tree supply
issues and ensuring long-term sustainability and stability.
Indena will also highlight other specialized pharmaceutical product offerings: Squalene, a key
immunological adjuvant for various vaccines, derived from Amaranthus plants. It is a responsible,
plant-based alternative to animal-derived sources, which often lack comparable environmental and
traceability assurances. Also featured is Cytisine, an effective anti-smoking agent, derived from
Laburnum anagyroides Medik plants, cultivated under a strictly controlled and fully traceable biomass
supply chain.
INDENA AND TCG GREENCHEM: A STRATEGIC COLLABORATION FOR NEXT-GENERATION ADC TECHNOLOGIES
On 28th October, Pietro Allegrini, Indena’s R&D Director, will formally announce a pivotal strategic
cooperation with TCG GreenChem, unifying Indena’s profound expertise in developing and
manufacturing high-potent payloads with TCG GreenChem’s innovative approaches in green chemistry
and highly efficient process development.
