When an injectable solution is administered, it bypasses the patient’s normal protective barriers. Skin and the digestive system no longer act as filters. At that point, the primary packaging becomes the barrier. That is the starting point for any sterility […]
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 […]
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