44 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 INDENA The integration of fully-contained freeze-drying and spray-drying technologies further elevates the HPAPI platform, combining advanced particle engineering with maximum containment. This is particularly important in ADC payload development, where powder handling, drying and micronisation can present significant exposure risks. As oncology pipelines continue to evolve toward higher potency and more complex modalities, this combination of chemistry, fermentation, containment engineering and scale-up flexibility becomes a decisive advantage. Addressing customers’ requirements When selecting an HPAPI CDMO, pharmaceutical and biotech companies consistently prioritise several key criteria: 1. Demonstrated containment performance at target OEL/OEB levels. 2. End-to-end technical depth, from route scouting and scale-up to commercial supply. 3. Advanced unit operations in high containment (centrifugation, filter drying, spray drying from organic solvents, preparative chromatography, fermentation/biotransformations where required). 4. Regulatory and quality credibility. 5. Supply chain resilience and sustainability. 6. ADC readiness. Indena’s platform has been deliberately engineered around these expectations. Containment down to 1 ng/cu m OEL demonstrates measurable OEB4/5 performance. Integrated R&D and GMP operations at Settala enable smooth transitions from early development to commercial production. Western European manufacturing mitigates geopolitical risks and supports regulatory alignment. System certifications and environmental and occupational safety programs reinforce credibility and long-term sustainability. At the same time, the company maintains the flexibility that small and mid-size pharmaceutical and biotech companies often require. Customised solutions, including dedicated equipment and multi-purpose pilot and industrial plants, allow sponsors to tailor development pathways without compromising containment or compliance. Strategic partnership In today’s HPAPI landscape, technical excellence alone is not sufficient. Customers must navigate increasingly complex development pathways, compressed timelines and heightened regulatory scrutiny. Indena addresses these challenges through early-stage R&D expertise integrated with scalable GMP production, strong analytical support, continuous infrastructure investments, fermentation and synthetic chemistry under a unified quality system and the ability to progress projects from clinical phases to commercial supply within a single, specialised site. This integrated model reduces hand-offs, simplifies technology transfer and strengthens knowledge continuity. These are factors that directly impact timeto-market and project risk. Trusted choice As HPAPI pipelines tilt toward ever-higher potency, narrower therapeutic windows and hybrid modalities such as ADCs, outsourcing strategies are becoming more selective. Clients are concentrating work with CDMOs that can demonstrate scalable containment, proven OEB4/5 performance and credible regulatory systems. Market signals consistently point to sustained growth in HPAPI outsourcing, driven by oncology and targeted therapies. In this expanding, but demanding environment, Indena offers a distinctive combination: - Ultra-low OEL handling down to approximately 1 ng/cu m. - Recent GMP capacity additions for potent isolation, drying and advanced synthesis. - Multi-route chemistry spanning natural, fermentation, semi-synthetic and synthetic approaches. - ADC payload and linker readiness supported by backward integration. - A Western European manufacturing base with robust regulatory standing. For pharmaceutical and biotech companies seeking a high-containment CDMO partner capable of combining chemistry breadth with containment finesse, Indena represents more than a service provider. It is a strategic collaborator equipped to translate scientific complexity into reliable, scalable manufacturing solutions. In the high-potency era, confidence is grounded in engineering discipline, scientific rigour and operational excellence. At Indena, these principles guide every stage of development and every molecule we produce. BERNARD VIANES Global CDMO Director Indena SpA
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