Highly potent active pharmaceutical ingredients (HPAPIs) are no longer a niche. They are at the center of modern pharmaceutical innovation. As oncology, targeted therapies, and precision medicine continue to reshape global pipelines, the demand for high-potency compounds is accelerating at a sustained pace.
Oncology dominates HPAPI utilization, accounting for roughly two-thirds to three-quarters of applications. The continued rise of antibody-drug conjugates (ADCs), small molecule warheads, steroidal hormones, and other selective compounds requiring occupational exposure limits (OELs) below 10 ng/m³, is reshaping expectations around containment, engineering controls, and process integration.
In this environment, customers are seeking partners with measurable high-containment performance, scalable infrastructure, regulatory credibility, and the ability to integrate complex chemistries under one roof. In this space Indena has built its distinctive CDMO proposition.
Indena’s evolution in high-potency manufacturing
Founded in 1921, Indena is widely known for its expertise in active ingredients derived from medicinal plants for pharmaceutical, nutraceutical and cosmetic applications. Over time, this heritage has expanded into advanced capabilities in the development and manufacturing of complex molecules, including highly potent APIs and ADC payloads.
A defining feature of the company’s model is the integration of R&D and GMP manufacturing in high-containment environments, enabling smooth progression from early development to clinical supply and commercial production.
High containment from development to commercial scale
Indena’s CDMO platform is engineered to handle compounds with OELs down to 1 ng/m³, supporting the safe development and production of ultra-potent molecules and ADC payloads.
The infrastructure includes a dedicated HPAPI kilolab, GMP manufacturing facilities capable of handling OEB5 compounds, advanced containment technologies such as isolated centrifugation and contained filter dryers, large-scale preparative chromatography, and particle engineering solutions including spray drying from organic solvents and contained freeze-drying systems.
Recent investments between 2024 and 2025 have further expanded reactor capacity up to 1,000 L, with plans for 3,000 L glass lined reactors, and added hydrogenation capability using Biazzi technology. These upgrades extend containment through critical steps such as isolation and drying, reducing operator exposure and minimizing cross-contamination risks.
Supporting next-generation oncology pipelines
Indena also combines synthetic chemistry, semi-synthetic processes, fermentation capabilities up to 20,000 L, and complex natural product handling within a unified high-containment framework. This technological breadth is particularly valuable in oncology and ADC development, where molecules often originate from complex natural scaffolds or fermentation-derived intermediates.
With 10 commercial HPAPIs and 13 molecules currently in clinical development, Indena continues to strengthen its position as a strategic CDMO partner capable of supporting increasingly complex and highly potent pharmaceutical pipelines.
Today, the company operates multiple GMP-certified sites in Italy and France, with its main CDMO hub located in Settala near Milan. These facilities operate under EU GMP with AIFA approval and are supported by certifications such as ISO 14001 and ISO 45001. Indena’s regulatory team also maintains extensive experience working with international authorities including FDA and EMA.
