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Onboarding a sterile injectable fill-finish Contract Development and Manufacturing Organisation (CDMO) involves eight structured steps: defining your manufacturing requirements, establishing selection criteria, conducting a formal technical audit, completing a feasibility assessment, compiling Chemistry, Manufacturing and Controls (CMC) documentation for European […]

To audit a sterile fill-finish Contract Development and Manufacturing Organisation (CDMO) effectively in 2026, assess nine core areas: quality management systems, contamination control strategy, facility and equipment qualification, technology transfer capability, data integrity controls, analytical and stability services, supply chain […]

How Overall Equipment Effectiveness Predicts Pre-Filled Syringe Capacity at a CDMO Overall Equipment Effectiveness (OEE) is the most reliable indicator of a Contract Development and Manufacturing Organisation’s (CDMO) true available capacity for pre-filled syringe fill-finish. It combines three measurable factors, […]

MUNICH, Germany – May 5th, 2026 – Adragos Pharma, a global contract development and manufacturing organization (CDMO), today announced the appointment of Konstantinos (Kostas) Rengis as its new Chief Executive officer, succeeding Dr. Andreas Raabe, who founded the company and […]

Transferring semisolid drug product manufacturing to a European Contract Development and Manufacturing Organisation requires structured planning across six distinct workstreams: scope definition, contract development and manufacturing organisation selection, Chemistry, Manufacturing and Controls package assembly, analytical method transfer, process characterisation and […]

A contract development and manufacturing organisation’s (CDMO’s) stated capacity for pre-filled syringe production is not the same as its verified, available and scalable capacity. For development and operations leaders making long-term sourcing decisions, understanding this distinction is essential. The metrics […]