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A value added medicine offers a practical route to a differentiated specialty product without the cost and risk of developing a new molecule. This guide explains what a value added medicine in specialty pharma is, why these products matter, the […]
Pharmaceutical scale-up for semi-solid and liquid products is the structured transfer of a formulation from laboratory or pilot scale to commercial manufacturing batches. The process requires alignment between formulation behaviour, equipment geometry, process parameters and quality controls, so that the […]
Scaling a sterile injectable from clinical batches to validated commercial supply is one of the most demanding transitions in pharmaceutical manufacturing. It requires synchronised progress across Contract Development and Manufacturing Organisation (CDMO) selection, technology transfer, Chemistry, Manufacturing and Controls (CMC) […]
Contents What Is Semisolid Technology Transfer? Why Semisolid Formulations Require a Dedicated Transfer Strategy The Core Stages of a Semisolid Technology Transfer Good Manufacturing Practice Alignment in European Semisolid Manufacturing Risk Management Throughout the Transfer Selecting a European CDMO for […]
Contents What a Pre-Filled Syringe Technology Transfer Involves Phase 1: Feasibility Assessment Phase 2: Documentation Compilation and Transfer Phase 3: Analytical Method Transfer and Stability Planning Phase 4: Equipment Mapping and Process Design Phase 5: Aseptic Process Simulation and Process […]
In sterile liquid manufacturing, equipment qualification is much more than a project milestone. It is one of the systems that protects patients, operators, product quality and GMP compliance. In a CDMO environment, where multiple clients, projects and expectations may coexist, […]
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