Indena, a global leader in the identification, development, and production of complex active pharmaceutical ingredients (APIs), today announced its participation in CPHI 2026, taking place October 6–8, 2026, at Fiera Milano. Exhibiting at Hall 3, Booth 3F9, Indena will present its integrated European Contract Development and Manufacturing Organization (CDMO) platform, designed to support pharmaceutical and biotechnology companies from route development through GMP commercial manufacturing.
As the pipeline for targeted oncology and precision medicines expands, demand continues to surge for highly potent active pharmaceutical ingredients (HPAPIs) requiring occupational exposure limits (OELs) down to the low-nanogram-per-cubic-meter range. Operating from its main Settala site near Milan, Indena leverages over a century of scientific expertise to deliver integrated containment strategies, process safety, advanced analytical control, and secure supply chains across complex natural, fermentation-derived, semisynthetic, and fully synthetic molecules.
The global CDMO market is undergoing a profound transformation, in which manufacturing capacity alone is no longer sufficient. Today, sponsors require deep technical integration, end-to-end supply-chain control, and a robust European manufacturing footprint. With the global market for high-potency APIs expanding rapidly, driven by targeted oncology and next-generation biotherapeutics, Indena’s ongoing investments at Settala reinforce our position as a trusted, single-interface partner. By combining fermentation, complex chemistry, purification, and particle engineering under one quality system, we provide pharmaceutical partners with the reliability and agility needed to develop life changing therapies.
Said Daniele Giavini, Managing Director of Indena.
At CPHI 2026, Indena will highlight four major technical capabilities advancing its European platform.
- Integrated European route for maytansinoid ADC payloads: to provide secure supply chains for critical antibody-drug conjugate (ADC) components, Indena manufactures the maytansinoid payloads DM1 and DM4 entirely in Europe. The platform fully integrates microbial fermentation of the ansamitocin intermediate with downstream synthesis and high-containment processing. Process validation for DM1 and DM4 is currently nearing completion, offering sponsors a single European interface for complex ADC payload-linkers.
- Ultra-high containment spray drying: expanding its particle engineering capabilities, Indena is commissioning a glovebox-integrated GMP spray dryer planned for operation by late 2027. Capable of handling organic solvents and OELs down to 1 ng/m³, this asset connects HPAPI development directly with commercial-scale particle engineering under extreme containment.
- Scalable cytisine sourcing: supporting smoking-cessation therapies, Indena has established a fully traceable, sustainably managed biomass supply chain for cytisine derived from Laburnum anagyroides Medik. Industrial-scale process validation is scheduled to begin in early 2027.
- QS-21 vaccine adjuvant strategy: addressing global supply bottlenecks for QS-21, a critical saponin adjuvant system used in FDA-approved vaccines and featured in over 120 clinical trials, Indena has been partnering with Desert King International for few years. The collaboration combines Desert King’s upstream botanical expertise and precursor supply with Indena’s downstream purification, chromatographic isolation, and final lyophilization.
The same scientific rigour extends across our entire platform, whether we are engineering 1 ng/m³ glovebox spray drying systems, or completing process validation for DM1 and DM4 payloads, or applying high containment analytical control from early route design through commercial release.
Our strategic partnership with Desert King on QS-21 demonstrates how we apply advanced analytical and separation sciences to overcome severe industry constraints. With global GMP capacity for QS-21 currently estimated at just 10 kg per year against a benchmark demand of 50 kg per year for key vaccine programs, our dual-horizon model establishes a dependable, scalable pathway for vaccine developers. This approach pairs current sustainably managed Chilean biomass with future clonal plantation sources to ensure long-term supply security.
Stated Nicola Sardone, R&D Analytical Research Director at Indena.
By co-locating R&D, analytical development, quality control and multi-scale GMP manufacturing at Settala, Indena minimizes technology transfers and preserves process knowledge across the drug lifecycle. Pharmaceutical and biotechnology companies can keep critical steps within one organisation rather than transferring processes among unrelated fermentation, chemistry, purification, and high-containment providers. From early route design to commercial GMP supply, Indena offers a single technical and quality framework for complex HPAPI programs, including the fast-evolving field of ADCs.
INDENA’S PRESENTATION AT CPHI 2026
Overcoming QS-21 Supply Constraints: A Scalable GMP Approach for Global Vaccine Preparedness, by Nicola Sardone, R&D Analytical Research Director at Indena. October 7th, 3:15 – 3:40 pm, Hall 2 – 2A132
VISIT INDENA AT CPHI 2026: HALL 3 BOOTH 3F9
October 6th to 8th, Fiera Milano, Italy
