43 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 INDENA authorities, including FDA, EMA and AIFA. What distinguishes Indena is not only regulatory compliance, but the integration of R&D and GMP manufacturing in high-containment environments – a combination that allows seamless progression from early development through clinical supply and into commercial production. High containment by design At the heart of Indena’s CDMO platform is its highcontainment capability, engineered to handle products with OELs down to 1 ng/cu m. This level of containment supports the safe development and manufacturing of ultra-potent small molecules and ADC payloads, where operator protection and cross-contamination control are paramount. The company’s infrastructure includes: - A dedicated HPAPI kilolab. - An expanded GMP synthetic plant capable of handling OEB5 compounds. - High-containment isolation technologies, including contained centrifugation and advanced filter dryers. - Preparative chromatography at large scale. - Particle engineering technologies such as PSD spray drying from organic solvents. - Fully contained freeze-drying systems integrated within glove boxes. Recent investments (2024–2025) have further strengthened the platform. These include the installation of a state-of-the-art contained filter dryer for highly potent molecules, increased reactor capacity up to 1,000 L with plans for 3,000 L enamel reactors and hydrogenation capability (Biazzi technology up to 10 bar). These upgrades extend end-to-end containment through isolation and drying, which are traditionally among the highest-risk process steps. This minimises operator exposure and prevents crosscontamination. The result is not just compliance, but engineered confidence across the full development lifecycle. Distinctive strengths One of Indena’s most distinctive strengths lies in its ability to combine diverse technological platforms within a unified high-containment framework. The company integrates: - Modern synthetic organic chemistry. - Semi-synthetic approaches. - Fermentation capabilities up to 20,000 L scale, including for toxic compounds. - Botanical extraction and complex natural product handling. - High-containment downstream processing. This breadth is particularly relevant for oncology programs and ADC payload development, where molecules often originate from complex natural scaffolds or require fermentation-based intermediates. By combining route scouting, process development, scale-up and high-containment manufacturing within a single co-ordinated environment, Indena can significantly streamline technology transfer and reduce development timelines. The company currently reports manufacturing ten commercial and 13 clinical-phase HPAPIs, reflecting sustained demand across oncology and other specialty areas. This track record demonstrates not only technical capability, but operational reliability at different stages of the product lifecycle. Oncology and antibody-drug conjugates The increasing number of oncology New Chemical Entities (NCEs), along with the rapid expansion of ADC pipelines, is reshaping CDMO requirements. ADCs, in particular, require precise co-ordination between toxin payload production, linker chemistry and strict containment controls. Indena has strategically positioned itself to support this field through advanced payload manufacturing down to 1 ng/cu m OEL, backward integration into microbial fermentation for toxin production, high-containment downstream processing, integrated freeze-drying and spray-drying technologies within glove boxes. Backward integration in fermentation enhances supply chain independence and reliability for critical ADC components, an increasingly important consideration in client decision-making. By controlling both upstream and downstream phases under high-containment conditions, Indena mitigates the risk of supply interruptions and quality variability.
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