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Why Implement Aggregation Alongside Serialization Now?
Regulations put in place by the US Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD) have significantly progressed the…
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Creating flexibility and efficiency in isolator-based filling with robotics and automation
Fill-finish is a critical part of biopharmaceutical manufacture, any mistakes at this point can lead to the product being mis-formulated, contaminated, or improperly packaged…
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Q&A: The Potential of Pulsed Light Decontamination in Sterile fill-finish
Reducing the risk of contamination when working in a sterile environment is a demanding process. If the filling process cannot be controlled to prevent…
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Choosing the Right Clinical Trial Solution for Distribution And Supply Optimization
Bringing a drug through clinical trials to the commercial market is an expensive and lengthy process which involves a network of moving parts. It…
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Supporting commercial gene therapies – transforming from supply-led to patient-led demand model
Cell and gene therapies (CGT) are unique in that they often target diseases or conditions for which no other therapy alternative exists, which makes…
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Embedding continuous improvement in clinical services and commercial drug packaging
Ever since the FDA first formalized the drive for continuous improvement (CI) in 2004, our industry has adopted and embedded the philosophy to apply better business…
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