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October 06-08, 2026
Milan, Lombardy, Italy
Our Capabilities
Designed for small‑volume programs, with end‑to‑end control from development through GMP production.
ADAPTED TO EVOLVING PROGRAMS
Orphan drug programs can evolve rapidly as clinical, regulatory, and supply requirements develop. We translate product and process knowledge into a production-ready manufacturing approach, with defined controls and documentation to support GMP manufacturing and ongoing supply.
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We formalize process knowledge, manufacturing instructions, and batch documentation to support progression into GMP manufacturing.
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We define critical process parameters and in-process controls to maintain consistent performance as the program advances.
Release control from clinical to commercial
Orphan drug programs require reliable analytical control as they progress from clinical development to routine supply. We establish fit-for-purpose analytical methods, release strategies, and stability programs to support consistent product quality throughout the product lifecycle.
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We align analytical methods and release requirements with product risks, development phase, and applicable GMP requirements.
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We generate stability data and manage method and specification updates as programs evolve to support reliable ongoing supply.
Our Services
Designed for rare disease programs, combining development, analytical readiness, and GMP small‑batch manufacturing.
Product Development
Manufacturing-ready development that reduces rework later, with decisions that scale as requirements increase.
Analytical Services
Clear data for decision-making stability plans, and confident release as your program progresses.
Manufacturing & Packaging
Consistent execution designed for predictable release and routine supply, with controlled changes over time.