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How to Choose a Sterile Fill-Finish CDMO When selecting a sterile fill-finish Contract Development and Manufacturing Organisation (CDMO), the most consequential evaluation criteria are regulatory compliance history, aseptic process technology, lyophilisation capability, clinical-to-commercial scalability, network redundancy, technology transfer rigour and […]
Sterile liquid manufacturing is unforgiving. A small lapse in control can become a patient risk, a batch disposition delay, an investigation that consumes weeks, or an interruption to supply. In that environment, in-process control (IPC) is not administrative overhead. It […]
A non-sterile liquid CDMO is the right partner for the products that do not need to be sterile: creams, gels, ointments and oral or topical liquids. These are the everyday medicines that make up a large share of most portfolios, […]
Choosing a CDMO for small batch injectables is one of the harder decisions in sterile drug development. A contract development and manufacturing organisation (CDMO) that suits a large commodity campaign is often the wrong fit for a small, high-value sterile […]
Moving clinical to commercial sterile injectables from trial batches to market supply is one of the most demanding transitions in drug manufacturing. This injectable pharmaceutical manufacturing scale-up has to increase batch size, line speed and annual volume while never weakening […]
In pharmaceutical development and manufacturing, stability testing is not simply a regulatory requirement. It is one of the most important ways we protect patients, preserve product quality, and maintain confidence in the product throughout its lifecycle. For sponsors outsourcing development […]
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