Contents Phase 1: Define Your Programme Requirements Phase 2: Due Diligence and Capability Screening Phase 3: Site Qualification and GMP Auditing Phase 4: Assemble the Technical Data Package Phase 5: Stakeholder Governance and Programme Management Phase 6: Technology Transfer from […]
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, […]
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 […]
From Clinic to Commercial Fill-Finish: A Guide for Biologic Manufacturing As biologic programmes transition from development to commercial fill-finish operations, the focus shifts from flexibility and speed to demonstrable understanding, validation, and lifecycle readiness. This phase is critical for ensuring […]
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