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Automation to guide technology shift in aseptic environments

European Pharmaceutical Review

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Yet in 2021, 100 nanomedicines had been marketed. Nanoparticle HIV vaccine shows potential in trial Nanomedicines generally require aseptic processing.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

1 (2021):48. 6540 (2021):341–42. Pharmaceutical Processing World. 1 (2021):7200. Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” PDA Journal of Pharmaceutical Science and Technology 75, no. 3 a b c Algorri, M., 3 (2022):593–607. Discussion paper.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Journal of Pharmaceutical Sciences (2021). 2021.09.046.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. 5 (September/October 2021). 2021.09.046 2021.

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Laboratory services poised for the digital revolution

Pharmaceutical Technology

According to GlobalData analysis, the number of clinical trials with a decentralised and virtual component increased by 50% between 2020 and 2021, and this trend is here to stay. The Covid-19 pandemic catalysed an enormous upswing in the adoption of innovations including telemedicine, wearables and remote patient monitoring.